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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,021 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00345683
The ClinicalTrials.gov registry entry for NCT00345683 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,021 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 Prevnar is the first listed.
NCT00345683 reports 0 study locations.
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.
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