NCT02173704

Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants in Taiwan.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.

Conditions

• Meningococcal Disease
• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Bexsero®	Four doses administered in the anterolateral area of the right or left thigh.
BIOLOGICAL	Routine vaccines	Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.

Timeline

• Start date: 2014-09-11
• Primary completion: 2015-12-25
• Completion: 2016-06-17
• First posted: 2014-06-25
• Last updated: 2020-08-25
• Results posted: 2018-06-15

Locations

2 sites across 1 country: Taiwan