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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 468 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00197236
The ClinicalTrials.gov registry entry for NCT00197236 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ActHIB™ is the first listed.
NCT00197236 reports 0 study locations.
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.
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