Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hi… (NCT00317122) | Clinical Trial Compass
CompletedPhase 3
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
South Africa192 participantsStarted 2004-10
Plain-language summary
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Who can participate
Age range
4 Days – 10 Days
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 infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Exclusion criteria:
* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious illness.
* Any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* A birth dose of hepatitis B vaccine given outside the frame of this study.
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
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.