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Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

Primary Purpose

Infections, Meningococcal

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Prevnar13
Pediarix
Hiberix
Rotarix
M-M-R II
Varivax
Placebo (saline water)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Meningococcal focused on measuring Meningitis, Immune response, Sufficiency, Neisseria meningitides, Bexsero

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits).
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
  • A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born full-term (i.e. after a gestation period of ≥ 38 weeks).

Exclusion Criteria:

If any exclusion criterion applies, the subject must not be included in the study:

• Child in care

Each subject must not have:

  • Progressive, unstable or uncontrolled clinical conditions.
  • Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study.
  • Hypersensitivity to latex.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Abnormal function of the immune system resulting from:

    • Clinical conditions.
    • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth.
    • Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth.
    • Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
  • Received immunoglobulins or any blood products from birth.
  • Received an investigational or non-registered medicinal product from birth.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
  • Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
  • Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
  • Study personnel as an immediate family or household member.
  • Current or previous, confirmed or suspected disease caused by N. meningitidis
  • Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization.
  • Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent.
  • Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed.
  • Serious chronic illness.
  • Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MenB+PCV Group

Placebo+PCV Group

Arm Description

Approximately 800 subjects enrolled in this group will receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prevnar13) and other RIV (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6 and 12 months of age.

Approximately 400 subjects enrolled in this group will receive PCV13 concomitantly with placebo and other RIV at 2, 4, 6 and 12 months of age.

Outcomes

Primary Outcome Measures

Percentages of subjects with solicited local and systemic Adverse Events (AEs)
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Percentages of subjects with solicited local and systemic AEs
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Percentages of subjects with solicited local and systemic AEs
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Percentages of subjects with solicited local and systemic AEs
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Percentages of subjects with solicited systemic AEs
For MMR and VV-specific solicited systemic AEs assessed are parotid/salivary gland swelling, fever and rash and are summarized. Each solicited systemic AE are further summarized as "any". "Any" = Occurrence of the solicited systemic AE regardless of intensity grade.
Percentages of subjects with all unsolicited AEs
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Percentages of subjects with all unsolicited AEs
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Percentages of subjects with all unsolicited AEs
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Percentages of subjects with all unsolicited AEs
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Percentages of subjects with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the subject from the study. Adverse events of special interest (AESIs) are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. A medically attended AE includes any AEs that requires medical visit.
Percentages of subjects with human serum bactericidal assay (hSBA) antibody titers ≥ Lower Limit of Quantitation (LLOQ) for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ at 1 month after the 3rd vaccination is demonstrated if the adjusted lower confidence limit for the percentage of subjects achieving hSBA titers ≥LLOQ is ≥60% for the N. meningitidis serogroup B test strains M14459, 96217, NZ98/254, M13520 (individually).
Percentages of subjects with hSBA antibody titers ≥LLOQ for all strains combined (M14459, 96217, NZ98/254 and M13520)
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ at 1 month after the 3rd vaccination is demonstrated if the adjusted lower confidence limit for the percentage of subjects achieving hSBA titers ≥LLOQ is ≥ 50% for all strains combined (composite endpoint).
Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for each of the test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ is demonstrated if the adjusted lower confidence limit for the percentage of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for the individual N. meningitidis serogroup B test strains.
Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for all strains combined (composite endpoint)
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ is demonstrated if the adjusted lower confidence limit for the percentage of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined (composite endpoint).
Antibody Geometric Mean Concentrations (GMC) using electrochemiluminescence (ECL) assay for each of the 13 PCV13 antigens
Pneumococcal serotype-specific immunoglobin G (IgG) antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).

Secondary Outcome Measures

Antibody GMCs using ECL for each of the 13 PCV13 serotypes
Pneumococcal serotype-specific IgG antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).
Percentages of subjects with serum pneumococcal anti-capsular polysaccharide IgG ≥0.35 μg/mL
Pneumococcal serotype-specific IgG antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).
GMCs against 3 pertussis antigens (pertussis toxin [PT], pertactin [PRN], filamentous hemagglutinin [FHA])
Antibodies (IgG's) against the pertussis components PT, PRN and FHA having 2.693, 2.187, 2.046 assay cut-off, respectively. The antibodies GMCs are measured by Enzyme linked immunosorbent assay (ELISA) expressed as International Units per millilitre (IU/mL) to evaluate the immunogenicity of acellular B. pertussis containing vaccines. The seropositivity for all 3 pertussis antibodies is based on new respective ELISA cut-off, where subjects with antibody concentration below the cut-off being considered seronegative. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Percentages of subjects with antibodies concentrations against hepatitis B surface antigen (AntiHBsAg) ≥10 mIU/mL
Antibodies against the anti-HBs are measured using a ChemiLuminescence ImmunoAssay (CLIA) expressed as milli-international units per millilitre. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥0.1 IU/mL
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets is performed by a second randomization, whereas the first ran-domization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Percentages of subjects with anti-polyribosyl-ribitol phosphate (PRP) concentration ≥0.15 µg/mL and ≥1 µg/mL
Concentrations of IgG antibodies against the Hib polysaccharide PRP is measured by ELISA. An immunological correlate of protection has been established when anti-PRP concentrations ≥0.15 µg/mL. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
GMCs for anti-Varicella (VV) antibodies
A suitable ELISA assay for analysis of anti-VV antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
GMCs for anti-measles antibodies
A suitable ELISA assay for analysis of anti-measles virus antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
GMCs for anti-mumps antibodies
A suitable ELISA assay for analysis of anti-mumps virus anti-body concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
GMCs for anti-rubella antibodies
A suitable ELISA assay for analysis of anti-rubella virus antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Percentages of subjects with hSBA antibody titers ≥5 and ≥8 and ≥16 for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5, and ≥8 and ≥16 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Percentages of subjects with hSBA antibody titers ≥5 and ≥8 for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5 and ≥8 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Percentages of subjects with hSBA antibody titers ≥5 for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
hSBA Geometric Mean Titers for the M14459, 96217, NZ98/254 and M13520 test strains
Serum antibody titers are presented as hSBA GMTs.The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The GMTs calculated is described for the four strains.
Percentages of subjects with hSBA antibody titers ≥LLOQ for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
hSBA Geometric Mean Ratios (GMR) of GMTs over pre 4th vaccination for the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The GMR calculated at one month post 4th vaccination versus pre-4th vaccination is described for the four strains.
Percentages of subjects with 4-fold rise in hSBA titers (from pre-4th vaccination) for each of the M14459, 96217, NZ98/254 and M13520 test strains
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. A 4-fold rise in hSBA titers is defined as: if pre-vaccination titer < LOD, then a post-vaccination titer ≥ 4 times the LOD or ≥ LLOQ, whichever is greater; if pre-vaccination titer is ≥LOD but <LLOQ, then a post-vaccination titer ≥4 times the LLOQ; if pre-vaccination titer is ≥LLOQ, then a post-vaccination titer ≥4 times the pre-vaccination titer, where pre-vaccination titer=pre-4th dose titers (Day 301).
Percentages of subjects with anti-HBs antibody concentrations ≥100 mIU/mL
Antibodies against the anti-HBs are measured using CLIA expressed as milli-international units per millilitre. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection.
GMCs for Anti-HBsAg antibodies
Antibodies against the anti-HBs is measured using CLIA. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection.
Percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥1 IU/mL
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected.
GMCs for anti-diphtheria and anti-tetanus antibodies
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected.
Percentages of subjects with anti-polio type 1, 2 and 3 neutralization antibody titers ≥8
Antibodies against poliovirus types 1, 2 and 3 are determined by a virus micro neutralization test. Titers are expressed in terms of the reciprocal of the dilution resulting in 50% inhibition (ED50TR). The assay cut-off for anti-polio 1, 2 and 3 is 8 ED50.
Percentages of subjects showing seroresponse for anti-Varicella (VV), anti-measles virus, anti-mumps virus and anti-rubella virus antibodies
Seroresponse is defined as post-vaccination anti-VV virus, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentration ≥ a protective threshold among subjects who were seronegative (antibody concentration <assay cut-off) before vaccination. A suitable ELISA assay for analysis of anti-VZV, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentrations is yet to be selected and/or developed.

Full Information

First Posted
July 10, 2018
Last Updated
July 20, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03621670
Brief Title
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Official Title
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).
Detailed Description
This study will be divided into 3 timepoints: Epoch 1- Primary- From Day 1 to Day 301 Epoch 2-Secondary-From Day 301 to Day 331 Epoch 3-Safety follow up -From Day 331 to study end (Day 481 or Day 661). For subjects who have not yet reached the 6-month safety follow-up after the last dose at the time protocol amendment 7 takes effect, Visit 7 will take place on Day 481. In addition to receiving the study vaccines, infants will also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix), to ease the disruption to the standard infant vaccine schedule caused by participating in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Meningitis, Immune response, Sufficiency, Neisseria meningitides, Bexsero

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Observer-blind study Data will be collected in an observer-blind manner. By observer blind, it is meant that during the course of the study, the subject/parent/caregiver, site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel are aware of the treatment assignment. To do so, vaccine preparation and administration will be done by authorized medical personnel who will not participate in any of the study clinical evaluation assays or procedures. The serological data, which would lead to the unblinding of the study groups, will not be available during the course of the study to any investigator or any person involved in the clinical conduct of the study. The laboratory in charge of the laboratory testing will be blinded to the treatment, subject and visit number, and codes will be used to link the subject, visit and study to each sample.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MenB+PCV Group
Arm Type
Experimental
Arm Description
Approximately 800 subjects enrolled in this group will receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prevnar13) and other RIV (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6 and 12 months of age.
Arm Title
Placebo+PCV Group
Arm Type
Placebo Comparator
Arm Description
Approximately 400 subjects enrolled in this group will receive PCV13 concomitantly with placebo and other RIV at 2, 4, 6 and 12 months of age.
Intervention Type
Biological
Intervention Name(s)
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Intervention Description
Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.
Intervention Type
Biological
Intervention Name(s)
Prevnar13
Intervention Description
Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
Pediarix
Intervention Description
Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
Hiberix
Intervention Description
Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
Rotarix
Intervention Description
Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
M-M-R II
Intervention Description
M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
Varivax
Intervention Description
Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.
Intervention Type
Biological
Intervention Name(s)
Placebo (saline water)
Intervention Description
Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.
Primary Outcome Measure Information:
Title
Percentages of subjects with solicited local and systemic Adverse Events (AEs)
Description
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Time Frame
During the 7-day follow-up period after the 1st vaccination
Title
Percentages of subjects with solicited local and systemic AEs
Description
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Time Frame
During the 7-day follow-up period after the 2nd vaccination
Title
Percentages of subjects with solicited local and systemic AEs
Description
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Time Frame
During the 7-day follow-up period after the 3rd vaccination
Title
Percentages of subjects with solicited local and systemic AEs
Description
Assessed solicited local AEs are hardness and swelling of the skin and redness, tenderness or discomfort to touch at injection site. Assessed solicited systemic AEs are decreased eating, increased sleepiness, vomiting/throwing up, loose stools/diarrhea, irritability, persistent/continuous crying and fever, defined as body temperature ≥38.0°C/100.4°F. Each solicited local and systemic AE are summarized as "any". Any=Occurrence of the solicited local/systemic AE regardless of the intensity grade.
Time Frame
During the 7-day follow-up period after the 4th vaccination
Title
Percentages of subjects with solicited systemic AEs
Description
For MMR and VV-specific solicited systemic AEs assessed are parotid/salivary gland swelling, fever and rash and are summarized. Each solicited systemic AE are further summarized as "any". "Any" = Occurrence of the solicited systemic AE regardless of intensity grade.
Time Frame
During the 30-day (Day 1 - Day 30) follow-up period after the 4th vaccination
Title
Percentages of subjects with all unsolicited AEs
Description
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Time Frame
During the 30-day follow-up period after the 1st vaccination
Title
Percentages of subjects with all unsolicited AEs
Description
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Time Frame
During the 30-day follow-up period after the 2nd vaccination
Title
Percentages of subjects with all unsolicited AEs
Description
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Time Frame
During the 30-day follow-up period after the 3rd vaccination
Title
Percentages of subjects with all unsolicited AEs
Description
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs.
Time Frame
During the 30-day follow-up period after the 4th vaccination
Title
Percentages of subjects with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
Description
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the subject from the study. Adverse events of special interest (AESIs) are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. A medically attended AE includes any AEs that requires medical visit.
Time Frame
Throughout the study period [Day 1 up to study end (Day 481 or Day 661)]
Title
Percentages of subjects with human serum bactericidal assay (hSBA) antibody titers ≥ Lower Limit of Quantitation (LLOQ) for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ at 1 month after the 3rd vaccination is demonstrated if the adjusted lower confidence limit for the percentage of subjects achieving hSBA titers ≥LLOQ is ≥60% for the N. meningitidis serogroup B test strains M14459, 96217, NZ98/254, M13520 (individually).
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with hSBA antibody titers ≥LLOQ for all strains combined (M14459, 96217, NZ98/254 and M13520)
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ at 1 month after the 3rd vaccination is demonstrated if the adjusted lower confidence limit for the percentage of subjects achieving hSBA titers ≥LLOQ is ≥ 50% for all strains combined (composite endpoint).
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for each of the test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ is demonstrated if the adjusted lower confidence limit for the percentage of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for the individual N. meningitidis serogroup B test strains.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for all strains combined (composite endpoint)
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine. The sufficiency of the immune response to rMenB+OMV NZ is demonstrated if the adjusted lower confidence limit for the percentage of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined (composite endpoint).
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
Antibody Geometric Mean Concentrations (GMC) using electrochemiluminescence (ECL) assay for each of the 13 PCV13 antigens
Description
Pneumococcal serotype-specific immunoglobin G (IgG) antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Secondary Outcome Measure Information:
Title
Antibody GMCs using ECL for each of the 13 PCV13 serotypes
Description
Pneumococcal serotype-specific IgG antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
Percentages of subjects with serum pneumococcal anti-capsular polysaccharide IgG ≥0.35 μg/mL
Description
Pneumococcal serotype-specific IgG antibodies is measured by validated multiplex assays (ECL1 and ECL2 assays).
Time Frame
At one month after the 3rd vaccination (Day 151) and one month after 4th vaccination (Day 331)
Title
GMCs against 3 pertussis antigens (pertussis toxin [PT], pertactin [PRN], filamentous hemagglutinin [FHA])
Description
Antibodies (IgG's) against the pertussis components PT, PRN and FHA having 2.693, 2.187, 2.046 assay cut-off, respectively. The antibodies GMCs are measured by Enzyme linked immunosorbent assay (ELISA) expressed as International Units per millilitre (IU/mL) to evaluate the immunogenicity of acellular B. pertussis containing vaccines. The seropositivity for all 3 pertussis antibodies is based on new respective ELISA cut-off, where subjects with antibody concentration below the cut-off being considered seronegative. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with antibodies concentrations against hepatitis B surface antigen (AntiHBsAg) ≥10 mIU/mL
Description
Antibodies against the anti-HBs are measured using a ChemiLuminescence ImmunoAssay (CLIA) expressed as milli-international units per millilitre. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥0.1 IU/mL
Description
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets is performed by a second randomization, whereas the first ran-domization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with anti-polyribosyl-ribitol phosphate (PRP) concentration ≥0.15 µg/mL and ≥1 µg/mL
Description
Concentrations of IgG antibodies against the Hib polysaccharide PRP is measured by ELISA. An immunological correlate of protection has been established when anti-PRP concentrations ≥0.15 µg/mL. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
GMCs for anti-Varicella (VV) antibodies
Description
A suitable ELISA assay for analysis of anti-VV antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
GMCs for anti-measles antibodies
Description
A suitable ELISA assay for analysis of anti-measles virus antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
GMCs for anti-mumps antibodies
Description
A suitable ELISA assay for analysis of anti-mumps virus anti-body concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
GMCs for anti-rubella antibodies
Description
A suitable ELISA assay for analysis of anti-rubella virus antibody concentrations is yet to be selected and/or developed. For the analysis of the immune responses to the Routine Infant Vaccine (RIV) antigens, subjects in each of the 2 study groups are randomly assigned to different immunogenicity subsets. The assignment of the immunogenicity subsets are performed by a second randomization, whereas the first randomization is performed at the enrolment to assign subjects to Group MenB+PCV or Group Placebo+PCV.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
Percentages of subjects with hSBA antibody titers ≥5 and ≥8 and ≥16 for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5, and ≥8 and ≥16 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with hSBA antibody titers ≥5 and ≥8 for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5 and ≥8 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Time Frame
At 6 months after the 3rd vaccination (Day 301)
Title
Percentages of subjects with hSBA antibody titers ≥5 for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The number of subjects having antibody titers ≥5 for each of the strains are presented. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
hSBA Geometric Mean Titers for the M14459, 96217, NZ98/254 and M13520 test strains
Description
Serum antibody titers are presented as hSBA GMTs.The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The GMTs calculated is described for the four strains.
Time Frame
At 1 month after the 3rd vaccination (Day 151) and 6 months after 3rd vaccination (Day 301) and 1 month after 4th vaccination (Day 331)
Title
Percentages of subjects with hSBA antibody titers ≥LLOQ for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. Each of these strains measures bactericidal activity primarily directed against one of the major bactericidal antigens included in the vaccine.
Time Frame
At 6 months after the 3rd vaccination (Day 301) and 1 month after 4th vaccination (Day 331)
Title
hSBA Geometric Mean Ratios (GMR) of GMTs over pre 4th vaccination for the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520. The GMR calculated at one month post 4th vaccination versus pre-4th vaccination is described for the four strains.
Time Frame
At 1 month after the 4th vaccination (Day 331) versus pre-4th vaccination (Day 301)
Title
Percentages of subjects with 4-fold rise in hSBA titers (from pre-4th vaccination) for each of the M14459, 96217, NZ98/254 and M13520 test strains
Description
The 4 selected meningococcal B strains are M14459, 96217, NZ98/254 and M13520 respectively. A 4-fold rise in hSBA titers is defined as: if pre-vaccination titer < LOD, then a post-vaccination titer ≥ 4 times the LOD or ≥ LLOQ, whichever is greater; if pre-vaccination titer is ≥LOD but <LLOQ, then a post-vaccination titer ≥4 times the LLOQ; if pre-vaccination titer is ≥LLOQ, then a post-vaccination titer ≥4 times the pre-vaccination titer, where pre-vaccination titer=pre-4th dose titers (Day 301).
Time Frame
At 1 month after the 4th vaccination (Day 331)
Title
Percentages of subjects with anti-HBs antibody concentrations ≥100 mIU/mL
Description
Antibodies against the anti-HBs are measured using CLIA expressed as milli-international units per millilitre. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
GMCs for Anti-HBsAg antibodies
Description
Antibodies against the anti-HBs is measured using CLIA. The cut-off of the test has been set at 6.2 mIU/mL. An antibody concentration ≥10 mIU/mL defines seroprotection.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥1 IU/mL
Description
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
GMCs for anti-diphtheria and anti-tetanus antibodies
Description
Specific antibodies against diphtheria toxoid (anti-diphtheria IgG's) and tetanus toxoid (anti-tetanus IgG's) are measured by ELISA. The clinical acceptable cut-off of ELISA was set at 0.1 IU/mL, which provided a conservative estimate of the percentage of subjects deemed to be protected.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects with anti-polio type 1, 2 and 3 neutralization antibody titers ≥8
Description
Antibodies against poliovirus types 1, 2 and 3 are determined by a virus micro neutralization test. Titers are expressed in terms of the reciprocal of the dilution resulting in 50% inhibition (ED50TR). The assay cut-off for anti-polio 1, 2 and 3 is 8 ED50.
Time Frame
At 1 month after the 3rd vaccination (Day 151)
Title
Percentages of subjects showing seroresponse for anti-Varicella (VV), anti-measles virus, anti-mumps virus and anti-rubella virus antibodies
Description
Seroresponse is defined as post-vaccination anti-VV virus, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentration ≥ a protective threshold among subjects who were seronegative (antibody concentration <assay cut-off) before vaccination. A suitable ELISA assay for analysis of anti-VZV, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentrations is yet to be selected and/or developed.
Time Frame
At 1 month after the 4th vaccination (Day 331)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits). Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination. Healthy subjects as established by medical history and clinical examination before entering into the study. Born full-term (i.e. after a gestation period of ≥ 38 weeks). Exclusion Criteria: If any exclusion criterion applies, the subject must not be included in the study: • Child in care Each subject must not have: Progressive, unstable or uncontrolled clinical conditions. Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study. Hypersensitivity to latex. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth. Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth. Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes). Received immunoglobulins or any blood products from birth. Received an investigational or non-registered medicinal product from birth. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions). Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders). Study personnel as an immediate family or household member. Current or previous, confirmed or suspected disease caused by N. meningitidis Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization. Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent. Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed. Serious chronic illness. Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
GSK Investigational Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
GSK Investigational Site
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
GSK Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
GSK Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
GSK Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
GSK Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
GSK Investigational Site
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
GSK Investigational Site
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
GSK Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
GSK Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
GSK Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
GSK Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
GSK Investigational Site
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GSK Investigational Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
GSK Investigational Site
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
GSK Investigational Site
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
GSK Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
GSK Investigational Site
City
Liverpool
State/Province
New York
ZIP/Postal Code
13090
Country
United States
Facility Name
GSK Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
GSK Investigational Site
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
GSK Investigational Site
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
GSK Investigational Site
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
GSK Investigational Site
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
GSK Investigational Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
GSK Investigational Site
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
GSK Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
GSK Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
GSK Investigational Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
254667
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
GSK Investigational Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501-2928
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
GSK Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
GSK Investigational Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
GSK Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
GSK Investigational Site
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
GSK Investigational Site
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
GSK Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
GSK Investigational Site
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com

Learn more about this trial

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

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