NCT03621670

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,196 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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).

Detailed description

This study is divided into three timepoints: Epoch 1 - Primary: Day 1 to Day 301 Epoch 2 - Secondary: Day 301 to Day 331 Epoch 3 - Safety follow-up: Day 331 to the end of the study (Day 481 or Day 661). For participants who have not yet reached the 6-month safety follow-up after their last dose at the time Protocol Amendment 7 takes effect, visit 7 takes place on Day 481. In addition to receiving the study vaccines, infants also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix) to minimize disruption to the standard infant vaccination schedule caused by participation in this study. Participants receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prevnar13) and other routine infant vaccines (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6, and 12 months of age. Participants who have received three PCV13 doses before 12 months of age but have not yet received their fourth booster dose receive either PCV13 or PCV20 at 12 months of age (Visit 5).

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-27
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2018-08-08
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

57 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study