The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.
Age range
12 Months – 15 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Timeframe: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Timeframe: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)