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

NCT03621670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1196

Last updated 2026-02-10

Study results available
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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).

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)

Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

Prevnar13

Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

Pediarix

Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.

BIOLOGICAL

Hiberix

Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121.

BIOLOGICAL

Rotarix

Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.

BIOLOGICAL

M-M-R II

M-M-R II (MMR) was administered intramuscularly on Day 301.

BIOLOGICAL

Varivax

Varivax (VV) was administered intramuscularly on Day 301.

BIOLOGICAL

Placebo (saline water)

Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

Prevnar 20

Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2024-12-27
Completion
2024-12-27
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621670 on ClinicalTrials.gov