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Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

Primary Purpose

Infections, Streptococcal

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)

Infanrix™ hexa.

Pediacel™

Prevenar™

About this trial

This is an interventional prevention trial for Infections, Streptococcal

Eligibility Criteria

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

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination.
Written informed consent obtained from both parents or from the guardian(s) of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine.
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
Children for whom hepatitis B vaccination is required according to the local recommendations
History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Synflorix + Infanrix hexa Group

Synflorix + Pediacel Group

Prevenar + Pediacel Group

Arm Description

Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid.

Subjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid.

Subjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid.

Outcomes

Primary Outcome Measures

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.

Antibody Concentration Against Protein D (PD) - Primary Vaccination

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.

Secondary Outcome Measures

Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination

Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.

Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination

Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination

Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination

Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.

Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.

Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination

Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.

Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination

Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination

Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.

Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.

Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.

A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations < 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).

Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.

Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.

Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.

Positive cultures of H. influenzae* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.

Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.

Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).

Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.

Acquisition of new H. influenzae* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.

Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.

Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).

Number of Subjects With Solicited Local Symptoms - Primary Vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (>) 30 millimeters from injection site.

Number of Subjects With Solicited General Symptoms - Primary Vaccination

Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.

Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Number of Subjects With Solicited Local Symptoms -Booster Vaccination

Number of Subjects With Solicited General Symptoms - Booster Vaccination.

Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Full Information

NCT ID

NCT00652951

First Posted

March 21, 2008

Last Updated

June 11, 2019

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00652951

Brief Title

Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

Official Title

Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2008 (Actual)

Primary Completion Date

May 12, 2009 (Actual)

Study Completion Date

December 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Streptococcal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

780 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Synflorix + Infanrix hexa Group

Arm Type

Active Comparator

Arm Description

Arm Title

Synflorix + Pediacel Group

Arm Type

Experimental

Arm Description

Arm Title

Prevenar + Pediacel Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™)

Intervention Description

Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination

Intervention Type

Biological

Intervention Name(s)

Infanrix™ hexa.

Intervention Description

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Intervention Type

Biological

Intervention Name(s)

Pediacel™

Intervention Description

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Intervention Type

Biological

Intervention Name(s)

Prevenar™

Intervention Description

Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

Primary Outcome Measure Information:

Title

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination

Description

Time Frame

At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

Title

Antibody Concentration Against Protein D (PD) - Primary Vaccination

Description

Time Frame

At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine

Secondary Outcome Measure Information:

Title

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination

Description

Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.

Description

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.

Description

Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

Time Frame

At Month 3, one month after the administration of the third vaccine dose

Title

Description

Time Frame

Prior to (Month 9) and one month after the administration of the booster dose (Month 10)

Title

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination

Description

Time Frame

Prior (Month 9) to and one month after the administration of the booster dose (Month 10)

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Time Frame

Prior (Month 9) to and one month after the administration of the booster dose(Month 10)

Title

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.

Description

Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Time Frame

Prior (Month 9) to and one month after the administration of the booster dose(Month 10)

Title

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination

Description

Time Frame

Prior (Month 9) to and one month after the administration of the booster dose (Month 10)

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Time Frame

Prior to (Month 9) and one month after the administration of the booster dose (Month 10)

Title

Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.

Description

Time Frame

Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

Title

Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.

Description

Time Frame

Prior to (Month 9) and one month after (Month 10) the administration of the booster dose

Title

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination

Description

Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.

Time Frame

Prior to (Month 9) and one month after (Month 10) the administration of the booster dose

Title

Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.

Description

Time Frame

Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

Title

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.

Description

Time Frame

Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

Title

Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.

Description

Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.

Time Frame

Prior (Month 9) to and one month after (Month 10) the administration of the booster dose

Title

Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.

Description

Time Frame

One month after (Month 10) the administration of the booster dose

Title

Description

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.

Description

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.

Description

Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.

Description

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.

Description

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.

Description

Time Frame

At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)

Title

Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.

Description

Time Frame

One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

Title

Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.

Description

Time Frame

Title

Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.

Description

Time Frame

Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

Title

Description

Time Frame

Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)

Title

Number of Subjects With Solicited Local Symptoms - Primary Vaccination

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Title

Number of Subjects With Solicited General Symptoms - Primary Vaccination

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Title

Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.

Description

Time Frame

Within the 31-day (Days 0-30) post-primary vaccination

Title

Number of Subjects With Serious Adverse Events (SAEs)

Description

Time Frame

Throughout the entire study period (up to Month 21)

Title

Number of Subjects With Solicited Local Symptoms -Booster Vaccination

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period following booster dose

Title

Number of Subjects With Solicited General Symptoms - Booster Vaccination.

Description

Time Frame

During the 4-day (Days 0-3) post-vaccination period following booster dose

Title

Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.

Description

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Time Frame

Within the 31-day (Days 0-30) after booster vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination. Written informed consent obtained from both parents or from the guardian(s) of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Born after a gestation period of at least 36 weeks. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine. Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae. Children for whom hepatitis B vaccination is required according to the local recommendations History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. History of any neurologic disorders or seizures. Acute disease at the time of enrolment. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

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 is available via the Clinical Study Data Request site (click on the link provided below)

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

http://clinicalstudydatarequest.com

Citations:

PubMed Identifier

21487327

Citation

van den Bergh MR, Spijkerman J, Francois N, Swinnen K, Borys D, Schuerman L, Veenhoven RH, Sanders EA. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial. Pediatr Infect Dis J. 2011 Sep;30(9):e170-8. doi: 10.1097/INF.0b013e31821a0614. Erratum In: Pediatr Infect Dis J. 2015 Aug;34(8):918. Dosage error in article text.

Results Reference

background

PubMed Identifier

23118268

Citation

van den Bergh MR, Spijkerman J, Swinnen KM, Francois NA, Pascal TG, Borys D, Schuerman L, Ijzerman EP, Bruin JP, van der Ende A, Veenhoven RH, Sanders EA. Effects of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine on nasopharyngeal bacterial colonization in young children: a randomized controlled trial. Clin Infect Dis. 2013 Feb;56(3):e30-9. doi: 10.1093/cid/cis922. Epub 2012 Nov 1.

Results Reference

background

PubMed Identifier

27097348

Citation

van den Bergh MR, Spijkerman J, Francois N, Swinnen K, Borys D, Schuerman L, Veenhoven RH, Sanders EA. Immunogenicity, Safety and Reactogenicity of a Booster Dose of the 10-Valent Pneumococcal Nontypeable H. influenzae Protein D Conjugate Vaccine Coadministered With DTPa-IPV-Hib in Dutch Children: A Randomized Controlled Trial. Pediatr Infect Dis J. 2016 Jul;35(7):e206-19. doi: 10.1097/INF.0000000000001170.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 110142 are summarised with study 111053 on GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110142

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

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