A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers

Summary

The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.

Timeline

Start

2021-05-26

Primary completion

2022-07-25

Completion

2022-07-25

Publications

• Background Martinon-Torres F, Salamanca de la Cueva I, Horn M, Westerholt S, Bosis S, Meyer N, Cheuvart B, Virk N, Jakes RW, Duchenne M, Van den Steen P. Disparate kinetics in immune response of two different Haemophilus influenzae type b conjugate vaccines: Immunogenicity and safety observations from a randomized controlled phase IV study in healthy infants and toddlers using a 2+1 schedule. Hum Vaccin Immunother. 2024 Dec 31;20(1):2342630. doi: 10.1080/21645515.2024.2342630. Epub 2024 Apr 30.

Drugs

Indications