drugset / Trial / NCT00814710
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
RandomizedParallel-groupSingle-blindPrevention
Summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.
Timeline
- Start
- 2009-03-07
- Primary completion
- 2009-11-13
- Completion
- 2009-11-13
Publications
- Background Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
- Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK1024850A | Vaccine | — | Intramuscular |
| Comparator | HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | Vaccine | — | Intramuscular |
| Comparator | Tritanrix-HepB | Vaccine | — | Intramuscular |
| Subject | Tritanrix-HepB/Hib | Unknown | — | Intramuscular |