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NCT01000974 · ClinicalTrials.gov registry record · Phase 3
Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,003
- Enrollment target
NCT01000974 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,003 participants.
The verdict
NCT01000974, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,003 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Interventions
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL Pentacel™
- BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)
- BIOLOGICAL ActHIB™
- BIOLOGICAL Pediarix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,003 participants |
| Start Date | 2010-06-18 |
| Est. Completion | 2013-07-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01000974
The ClinicalTrials.gov registry entry for NCT01000974 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,003 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 13™ is the first listed.
NCT01000974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01000974 about?
NCT01000974 is a clinical study titled "Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants". The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the ...
What is the current status of trial NCT01000974?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,003 participants. The study started on 2010-06-18. Estimated completion is 2013-07-17.
What interventions are being tested in trial NCT01000974?
The interventions under investigation include: Prevnar 13™ (BIOLOGICAL), Pentacel™ (BIOLOGICAL), GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) (BIOLOGICAL), ActHIB™ (BIOLOGICAL), Pediarix™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01000974?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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