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NCT00289783 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,441
- Enrollment target
NCT00289783: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00289783 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,441 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (475% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00289783, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,441 participants
- Enrollment target
Study Summary
This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.
Primary Outcome
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Interventions
- BIOLOGICAL Pediarix
- BIOLOGICAL Prevnar
- BIOLOGICAL ActHIB
- BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
- BIOLOGICAL PedvaxHIB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,441 participants |
| Start Date | 2006-02-22 |
| Est. Completion | 2008-02-26 |
| Phase | Phase 3 |
What the finished NCT00289783 record still lists
NCT00289783 is an interventional study that assigns participants to a tested intervention. Its 4,441 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (475% higher).
The record links to 0 conditions, and to 5 interventions - of which Pediarix is the first listed.
NCT00289783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00289783 about?
NCT00289783 is a clinical study titled "Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine". This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months...
What is the current status of trial NCT00289783?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,441 participants. The study started on 2006-02-22. Estimated completion is 2008-02-26.
What interventions are being tested in trial NCT00289783?
The interventions under investigation include: Pediarix (BIOLOGICAL), Prevnar (BIOLOGICAL), ActHIB (BIOLOGICAL), GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine (BIOLOGICAL), PedvaxHIB (BIOLOGICAL).
Who is sponsoring clinical trial NCT00289783?
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 NCT00289783's enrollment target sits among peer trials
4,441 56th of 2000 higher than 1,945 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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