To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine
All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
175
GSK Investigational Site
City of Muntinlupa, Philippines
Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).
Immunology
At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
Reactogenicity and Safety
Occurrence of solicited symptoms during the specific follow-up period after the booster dose.
Occurrence of unsolicited symptoms during the specific follow-up period after the booster dose .
Occurrence of serious adverse events (SAEs) during the entire study period."
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