Immune memory of DTPw-HBV/Hib vaccine following primary vaccination, immuno & reacto of a booster dose given in infants
Trial overview
Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Timeframe: At Month 1, post-PRP challenge
Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Timeframe: At Month 1, post-booster vaccination
Number of seroprotected subjects against diphteria (D) and tetanus (T)
Timeframe: At Month 1, post-booster vaccination
Seroprotection rates for anti-D antibodies
Timeframe: At Month 1, post-booster vaccination
Number of seroprotected subjects against Hepatitis B surface antigen (HBs)
Timeframe: At Month 1, post-booster vaccination
Number of seroprotected subjects against Bordetella pertussis (BPT)
Timeframe: At Month 1, post-booster vaccination
Number of subjects with booster response to BPT antigen
Timeframe: At Month 1, post-booster vaccination
Anti-PRP antibody concentrations
Timeframe: At Month 1, post-PRP challenge
Anti-PRP antibody concentrations.
Timeframe: At Month 1, post-booster vaccination
Anti-D and anti-T antibody concentrations
Timeframe: At Month 1, post-booster vaccination
Anti-HBs antibody concentrations
Timeframe: At Month 1, post-booster vaccination
Anti-BPT antibody concentrations
Timeframe: At Month 1, post-booster vaccination
Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Timeframe: At Month 0, prior to the PRP challenge
Number of subjects with anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
Timeframe: At Month 0, prior to the PRP challenge
Number of subjects with anti-D and anti-T antibody concentrations ≥ the cut-off value
Timeframe: At Month 0, prior to the PRP challenge
Seroprotection rates for anti-D antibodies
Timeframe: At Month 0, prior to the PRP challenge
Number of subjects with anti-HBs antibody concentrations ≥ the cut-off value
Timeframe: At Month 0, prior to the PRP challenge
Number of subjects with anti-BPT antibody concentrations ≥ the cut-off value
Timeframe: At Month 0, prior to the PRP challenge
Anti- PRP antibody concentrations
Timeframe: At Month 0, prior to the PRP challenge
Anti- PRP antibody concentrations.
Timeframe: At Month 0, prior to the PRP challenge
Anti-D and anti-T antibody concentrations.
Timeframe: At Month 0, prior to the PRP challenge
Anti-HBs antibody concentrations.
Timeframe: At Month 0, prior to the PRP challenge
Anti-BPT antibody concentrations.
Timeframe: At Month 0, prior to the PRP challenge
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-Day (Days 0-3) post-PRP challenge
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-Day (Days 0-3) post-PRP challenge
Number of subjects with any and Grade 3 solicited local symptoms.
Timeframe: During the 4-Day (Days 0-3) post-booster vaccination period
Number of subjects with any, Grade 3 and related solicited general symptoms.
Timeframe: During the 4-Day (Days 0-3) post-booster vaccination period
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-Day (Day 0-30) follow-up period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 to Month 9.5)
Participation criteria
- Inclusion criteria:
- For subjects receiving Plain PRP followed by DTPw-HBV:
- 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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.