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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00129129 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 756 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (468% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
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 |
What the finished NCT00129129 record still lists
NCT00129129 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (468% higher).
The record links to 0 conditions, and to 5 interventions - of which Pediarix is the first listed.
NCT00129129 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00129129's enrollment target sits among peer trials
756 43rd of 2000 higher than 1,958 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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