Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Timeline

Start

2010-09-27

Primary completion

2011-11-03

Completion

2012-10-01

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); 10PP-LD/Infanrix Hexa Group vs Synflorix/Infanrix Hexa Group; p = 0.003; Difference in percentage 0 (95% CI -2.61 to 2.57) NCT01204658 ↗

registry analysis (non-inferiority or equivalence test); 10PP-HD/Infanrix Hexa Group vs Synflorix/Infanrix Hexa Group; p = 0.003; Difference in percentage 0 (95% CI -2.61 to 2.64) NCT01204658 ↗

Publications

• Background Prymula R, Szenborn L, Silfverdal SA, Wysocki J, Albrecht P, Traskine M, Gardev A, Song Y, Borys D. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants. Vaccine. 2017 Aug 16;35(35 Pt B):4603-4611. doi: 10.1016/j.vaccine.2017.07.008. Epub 2017 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK2189242A	Vaccine	—	Intramuscular
Comparator	Prevenar 13	Vaccine	—	Intramuscular
Comparator	Synflorix	Vaccine	—	Intramuscular
Background	Infanrix hexa	Vaccine	—	Intramuscular

Indications