drugset / Trial / NCT01153841
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
Timeline
- Start
- 2011-02-17
- Primary completion
- 2011-07-26
- Completion
- 2011-07-26
Publications
- Background Huu TN, Toan NT, Tuan HM, Viet HL, Le Thanh Binh P, Yu TW, Shafi F, Habib A, Borys D. Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 2013 Feb 21;13:95. doi: 10.1186/1471-2334-13-95.
- Background Tran NH et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. Abstract presented at the ICID, Bangkok, Thailand, June 13-16, 2012.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Synflorix | Vaccine | — | Intramuscular |
| Background | Infanrix hexa | Vaccine | — | Intramuscular |