search
Back to results

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

Primary Purpose

Infections, Meningococcal

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MenABCWY-2Gen low dose vaccine
MenABCWY-2Gen high dose vaccine
MenABCWY-1Gen vaccine
MenB vaccine
MenACWY-TT vaccine
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 MenABCWY-2Gen, MenABCWY-1Gen, Bexsero, Nimenrix, Safety, Tolerability, Immunogenicity, Invasive Meningococcal Disease, Healthy infants

Eligibility Criteria

55 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants' 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.
  • Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
  • Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

Exclusion Criteria:

Medical conditions

  • Current or previous, confirmed or suspected disease caused by N. meningitidis.
  • Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
  • Progressive, unstable or uncontrolled clinical conditions.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
  • Congenital or peripartum disorders resulting in a chronic condition
  • Major congenital defects, as assessed by the investigator.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
  • Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
  • Abnormal function or modification of the immune system resulting from:
  • Autoimmune disorders or immunodeficiency syndromes.
  • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
  • Previous vaccination with any meningococcal vaccine.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other exclusions

  • Child in care.
  • Study personnel as an immediate family or household member.
  • For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

ABCWY-2Gen low dose Group

MenB+MenACWY-TT Group

ABCWY-2Gen high dose Group

ABCWY-1Gen Group

Arm Description

Participants receive 3 doses of the MenABCWY-2Gen low dose vaccine.

Participants receive 3 doses of both the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine.

Participants receive 3 doses of the MenABCWY-2Gen high dose vaccine in.

Participants receive 3 doses of the MenABCWY-1Gen vaccine.

Outcomes

Primary Outcome Measures

Percentage of participants with solicited administration site events
The solicited administration site events include tenderness, erythema, induration and swelling.
Percentage of participants with solicited systemic events
The solicited systemic events include fever, irritability/fussiness, loss of appetite, drowsiness, vomiting and diarrhoea. Fever is defined as temperature >38.0°C/100.4°F. The preferred location for measuring temperature will be axillary.
Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs)
Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way Analysis of Variance (ANOVA) with factors for arms and center.
hSBA GMTs for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
hSBA GMTs for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
hSBA GMTs for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
hSBA GMTs for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
hSBA GMTs for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Within group hSBA GMRs for each A, C, W and Y serogroup
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis A, C, W and Y serogroups at Day 331 compared to Day 301.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
March 8, 2023
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT05082285
Brief Title
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
Official Title
A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
MenABCWY-2Gen, MenABCWY-1Gen, Bexsero, Nimenrix, Safety, Tolerability, Immunogenicity, Invasive Meningococcal Disease, Healthy infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
688 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABCWY-2Gen low dose Group
Arm Type
Experimental
Arm Description
Participants receive 3 doses of the MenABCWY-2Gen low dose vaccine.
Arm Title
MenB+MenACWY-TT Group
Arm Type
Active Comparator
Arm Description
Participants receive 3 doses of both the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine.
Arm Title
ABCWY-2Gen high dose Group
Arm Type
Experimental
Arm Description
Participants receive 3 doses of the MenABCWY-2Gen high dose vaccine in.
Arm Title
ABCWY-1Gen Group
Arm Type
Experimental
Arm Description
Participants receive 3 doses of the MenABCWY-1Gen vaccine.
Intervention Type
Combination Product
Intervention Name(s)
MenABCWY-2Gen low dose vaccine
Intervention Description
MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.
Intervention Type
Combination Product
Intervention Name(s)
MenABCWY-2Gen high dose vaccine
Intervention Description
MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.
Intervention Type
Combination Product
Intervention Name(s)
MenABCWY-1Gen vaccine
Intervention Description
MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.
Intervention Type
Combination Product
Intervention Name(s)
MenB vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.
Intervention Type
Combination Product
Intervention Name(s)
MenACWY-TT vaccine
Other Intervention Name(s)
Nimenrix
Intervention Description
MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.
Primary Outcome Measure Information:
Title
Percentage of participants with solicited administration site events
Description
The solicited administration site events include tenderness, erythema, induration and swelling.
Time Frame
During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
Title
Percentage of participants with solicited systemic events
Description
The solicited systemic events include fever, irritability/fussiness, loss of appetite, drowsiness, vomiting and diarrhoea. Fever is defined as temperature >38.0°C/100.4°F. The preferred location for measuring temperature will be axillary.
Time Frame
During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
Title
Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs)
Description
Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Time Frame
During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
Title
Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
Description
MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Time Frame
During the study period (Day 1 through Day 481)
Title
Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Time Frame
At 1 month after the second vaccination (Day 91)
Title
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Time Frame
At pre-third vaccination (Day 301)
Title
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Time Frame
At 1 month after the third vaccination (Day 331)
Title
hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way Analysis of Variance (ANOVA) with factors for arms and center.
Time Frame
At 1 month after the second vaccination (Day 91)
Title
hSBA GMTs for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Time Frame
At pre-third vaccination (Day 301)
Title
hSBA GMTs for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Time Frame
At 1 month after the third vaccination (Day 331)
Title
Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.
Time Frame
At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
Title
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Time Frame
At 1 month after the second vaccination (Day 91)
Title
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Time Frame
At pre-third vaccination (Day 301)
Title
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Time Frame
At 1 month after the third vaccination (Day 331)
Title
hSBA GMTs for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Time Frame
At 1 month after the second vaccination (Day 91)
Title
hSBA GMTs for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Time Frame
At pre-third vaccination (Day 301)
Title
hSBA GMTs for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Time Frame
At 1 month after the third vaccination (Day 331)
Title
Within group hSBA GMRs for each A, C, W and Y serogroup
Description
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis A, C, W and Y serogroups at Day 331 compared to Day 301.
Time Frame
At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants' 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. Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. Healthy participants as established by medical history and clinical examination before entering into the study. A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination. Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg. Exclusion Criteria: Medical conditions Current or previous, confirmed or suspected disease caused by N. meningitidis. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth. Progressive, unstable or uncontrolled clinical conditions. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures. Congenital or peripartum disorders resulting in a chronic condition Major congenital defects, as assessed by the investigator. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s). Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study. Abnormal function or modification of the immune system resulting from: Autoimmune disorders or immunodeficiency syndromes. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. Administration of antineoplastic and immunomodulating agents or radiotherapy from birth. Administration of long-acting immune-modifying drugs at any time during the study period. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period. Previous vaccination with any meningococcal vaccine. Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device). Other exclusions Child in care. Study personnel as an immediate family or household member. For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Benita Ukkonen
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Susanna Koski
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Susanna Koski
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Miia Virta
Facility Name
GSK Investigational Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Pauliina Paavola
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Satu Kokko
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ilkka Seppa
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Outi Laajalahti
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ilkka Seppa
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ilkka Seppa
Facility Name
GSK Investigational Site
City
Gilching
State/Province
Bayern
ZIP/Postal Code
82205
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Manfred Praun
Facility Name
GSK Investigational Site
City
Schoenau Am Koenigssee
State/Province
Bayern
ZIP/Postal Code
83471
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Michael Horn
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Raffaele Badolato
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Piotr Korbal
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-542
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Aleksander Krasnow
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Hanna Czajka
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
30-644
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Izabela Tarczon
Facility Name
GSK Investigational Site
City
Lubon
ZIP/Postal Code
62-030
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Joanna Stryczynska-Kazubska
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Barbara Pajek
Facility Name
GSK Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Elzbieta Kopinska
Facility Name
GSK Investigational Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Henryk Szymanski
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ernest Kuchar
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50368
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Leszek Szenborn
Facility Name
GSK Investigational Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Lisa Jose
Facility Name
GSK Investigational Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Manuel Baca
Facility Name
GSK Investigational Site
City
Almeria
ZIP/Postal Code
04120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Francisco Giménez Sánchez
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jose Manuel Merino Arribas
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jose Tomas Ramos Amador
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Pablo Rojo Conejo
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Fernando Baquero Artigao
Facility Name
GSK Investigational Site
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Agustín López López
Facility Name
GSK Investigational Site
City
Marbella
ZIP/Postal Code
29600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Javier Álvarez Aldeán
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Federico Martinón-Torres
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ignacio Salamanca De La Cueva
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Anu Goenka
Facility Name
GSK Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sian Ludman
Facility Name
GSK Investigational Site
City
Headington, Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Dominic Kelly
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Rachel Isba

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, a 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.

Learn more about this trial

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

We'll reach out to this number within 24 hrs