drugset / Trial / NCT00384059
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.
Timeline
- Start
- 2006-10
- Primary completion
- 2008-10
- Completion
- 2008-10
Publications
- Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
- Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 13-valent pneumococcal conjugate vaccine | Vaccine | 0.5 ml | — |
| Comparator | 7vPnC | Vaccine | 0.5 ml | — |
| Subject | Menitorix | Vaccine | — | — |
| Subject | NeisVac-C | Vaccine | — | — |
| Subject | Pediacel® | Vaccine | — | — |
Indications
No indication recorded.