CompletedPhase 2

A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

Philippines450 participantsStarted 2003-07

Plain-language summary

The purpose of the study is as follows: * To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects. * To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

Who can participate

Age range

10 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: • Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents. Exclusion criteria: * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV). * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period. * Chronic administration (\> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001. * History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

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

Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.

Trial details

NCT IDNCT00317174

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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