Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster… (NCT00169442) | Clinical Trial Compass
CompletedPhase 3
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Philippines745 participantsStarted 2005-02-10
Plain-language summary
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Who can participate
Age range10 Months – 18 Months
SexALL
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Inclusion criteria:
For subjects receiving Plain PRP followed by DTPw-HBV:
Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:
Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
For all subjects:
* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
* Free of obvious health problems as established by medical history and clinical examination
Exclusion criteria:
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
* Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
What they're measuring
1
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Timeframe: At Month 1, post-PRP challenge
2
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Timeframe: At Month 1, post-booster vaccination
3
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Timeframe: At Month 1, post-booster vaccination
4
Seroprotection Rates for Anti-D Antibodies
Timeframe: At Month 1, post-booster vaccination
5
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Timeframe: At Month 1, post-booster vaccination
6
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
Timeframe: At Month 1, post-booster vaccination
7
Number of Subjects With Booster Response to BPT Antigen