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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,441 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00289783
The ClinicalTrials.gov registry entry for NCT00289783 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,441 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 5 interventions - of which Pediarix is the first listed.
NCT00289783 reports 0 study locations.
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.
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