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NCT00345683 · ClinicalTrials.gov registry record · Phase 3
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,021
- Enrollment target
NCT00345683: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00345683 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,021 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (421% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00345683, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,021 participants
- Enrollment target
Study Summary
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Interventions
- BIOLOGICAL Prevnar
- BIOLOGICAL M-M-R II
- BIOLOGICAL Varivax
- BIOLOGICAL PedvaxHIB
- BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,021 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00345683 record still lists
NCT00345683 is an interventional study that assigns participants to a tested intervention. Its 4,021 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 (421% higher).
The record links to 0 conditions, and to 5 interventions - of which Prevnar is the first listed.
NCT00345683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00345683 about?
NCT00345683 is a clinical study titled "Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.". The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of...
What is the current status of trial NCT00345683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,021 participants. The study started on 2007-07. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00345683?
The interventions under investigation include: Prevnar (BIOLOGICAL), M-M-R II (BIOLOGICAL), Varivax (BIOLOGICAL), PedvaxHIB (BIOLOGICAL), GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00345683?
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 NCT00345683's enrollment target sits among peer trials
4,021 61st of 2000 higher than 1,940 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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