Clinical Trial: Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Assess the Immunogenicity &d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals' DTPw-HBV/Hib Vaccine at 15-18 Mths of Age in Infants Previously Prim
Brief Summary: 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
Detailed Summary: 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.
Sponsor: GlaxoSmithKline
Current Primary Outcome: Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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."
Original Secondary Outcome:
- "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."
Information By: GlaxoSmithKline
Dates:
Date Received: September 8, 2005
Date Started: January 2005
Date Completion:
Last Updated: February 10, 2011
Last Verified: February 2011