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NCT00129129 · ClinicalTrials.gov registry record · Phase 2
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 756
- Enrollment target
NCT00129129 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 756 participants.
The verdict
NCT00129129, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 756 participants
- Enrollment target
Study Summary
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Interventions
- BIOLOGICAL Pediarix
- BIOLOGICAL Prevnar
- BIOLOGICAL ActHIB
- BIOLOGICAL GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
- BIOLOGICAL Menomune
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2004-08-01 |
| Est. Completion | 2006-03-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00129129
The ClinicalTrials.gov registry entry for NCT00129129 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 756 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.
NCT00129129 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00129129 about?
NCT00129129 is a clinical study titled "Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine". This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide va...
What is the current status of trial NCT00129129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 756 participants. The study started on 2004-08-01. Estimated completion is 2006-03-29.
What interventions are being tested in trial NCT00129129?
The interventions under investigation include: Pediarix (BIOLOGICAL), Prevnar (BIOLOGICAL), ActHIB (BIOLOGICAL), GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine (BIOLOGICAL), Menomune (BIOLOGICAL).
Who is sponsoring clinical trial NCT00129129?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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