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 range
10 Months – 18 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.
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.
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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