Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,196

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2018

Longer than P75 for phase_3

Geographic Reach

2 countries

57 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.4 years study duration

First Submitted

Initial submission to the registry

July 10, 2018

Completed

17 days until next milestone

Study Start

First participant enrolled

July 27, 2018

Completed

12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2026

Completed

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6.4 years

First QC Date

July 10, 2018

Results QC Date

December 23, 2025

Last Update Submit

February 9, 2026

Conditions

Infections, Meningococcal

Keywords

MeningitisImmune responseSufficiencyNeisseria meningitidesBexsero

Outcome Measures

Primary Outcomes (19)

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.
Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Rotarix was administered orally; therefore, no administration site events were analyzed.
Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Day 121 to Day 127
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Day 121 to Day 127
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Day 301 to Day 307
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301
Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Day 301 to Day 330
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered at Day 1
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.
Day 1 to Day 30
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered at Day 61
Day 61 to Day 90
Number of Participants Reporting Any Unsolicted AEs After the Third Vaccination Administered at Day 121
Day 121 to Day 150
Number of Participants Reporting Any Unsolicited AEs After the Fourth Vaccination Administered at Day 301
Day 301 to Day 330
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Day 1 up to study end (Day 481 for participants who have not reached 6-month follow-up at the time of Protocol Amendment 7; Day 661 for all others)
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Titers >= LLOQ Against All Serogroup B Test Strains Combined (Composite Response)
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp), NZ98/254 (PorA P1.4), and M13520 (NHBA) and >= 16 for Strain 96217 (NadA) (Composite Response Across All Strains)
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
At Day 331 (1 month after the fourth vaccination)
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.
At Day 151 (1 month after the third vaccination)

Secondary Outcomes (23)

Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
At Day 151 (1 month after the third vaccination) and Day 331 (1 month after the fourth vaccination)
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])
At Day 151 (1 month after the third vaccination)
Percentage of Participants With Antibodies Concentrations Against Hepatitis B Surface Antigen (AntiHBsAg) >= 10 mIU/mL
At Day 151 (1 month after the third vaccination)
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL
At Day 151 (1 month after the third vaccination)
+18 more secondary outcomes

Study Arms (2)

MenB+PCV Group

EXPERIMENTAL

Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Biological: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)Biological: Prevnar13Biological: PediarixBiological: HiberixBiological: RotarixBiological: M-M-R IIBiological: VarivaxBiological: Prevnar 20

Placebo+PCV Group

PLACEBO COMPARATOR

Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Biological: Prevnar13Biological: PediarixBiological: HiberixBiological: RotarixBiological: M-M-R IIBiological: VarivaxBiological: Placebo (saline water)Biological: Prevnar 20