CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,196 enrolled
Drug / intervention
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) +8 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03621670
NCT03621670Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Aug 8, 2018·Updated Feb 10, 2026

In Brief

A Phase 3 clinical trial evaluating Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, and 7 other interventions for Infections, Meningococcal. Completed, enrolled 1,196 participants across 57 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 8, 2018
Enrollment StartJul 27, 2018
Primary CompletionDec 27, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 7.9 years ago

Interventions

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

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

Prevnar13biological

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

Pediarixbiological

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

Hiberixbiological

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

Rotarixbiological

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

M-M-R IIbiological

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

Varivaxbiological

Varivax (VV) was administered intramuscularly on Day 301.

Placebo (saline water)biological

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

Prevnar 20biological

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.