Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine Administered on a 0-6 Mth Schedule Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine in Healthy Children 15 Months of Age|
- Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group. [ Designated as safety issue: No ]
- Immune response for Prevnar following vaccination in both the Havrix + Prevnar group and the Prevnar followed by Havrix group. [ Designated as safety issue: No ]
- Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines. [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Biological: Hepatitis A
An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.