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NCT00197236 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 468
- Enrollment target
NCT00197236: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00197236 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 468 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00197236, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 468 participants
- Enrollment target
Study Summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Interventions
- BIOLOGICAL ActHIB™
- BIOLOGICAL Havrix™
- BIOLOGICAL Infanrix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2003-11-11 |
| Est. Completion | 2007-12-03 |
| Phase | Phase 3 |
What the finished NCT00197236 record still lists
NCT00197236 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 3 interventions - of which ActHIB™ is the first listed.
NCT00197236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00197236 about?
NCT00197236 is a clinical study titled "Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months". This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posti...
What is the current status of trial NCT00197236?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2003-11-11. Estimated completion is 2007-12-03.
What interventions are being tested in trial NCT00197236?
The interventions under investigation include: ActHIB™ (BIOLOGICAL), Havrix™ (BIOLOGICAL), Infanrix™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00197236?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00197236's enrollment target sits among peer trials
468 816th of 2000 higher than 1,185 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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