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NCT02096263 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 585
- Enrollment target
NCT02096263 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 585 participants.
The verdict
NCT02096263, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 585 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
Interventions
- BIOLOGICAL Infanrix hexa
- BIOLOGICAL Pediarix
- BIOLOGICAL Engerix-B
- BIOLOGICAL ActHIB
- BIOLOGICAL Pentacel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 585 participants |
| Start Date | 2014-04-16 |
| Est. Completion | 2015-11-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02096263
The ClinicalTrials.gov registry entry for NCT02096263 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 585 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 Infanrix hexa is the first listed.
NCT02096263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02096263 about?
NCT02096263 is a clinical study titled "Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants". The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberi...
What is the current status of trial NCT02096263?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 585 participants. The study started on 2014-04-16. Estimated completion is 2015-11-13.
What interventions are being tested in trial NCT02096263?
The interventions under investigation include: Infanrix hexa (BIOLOGICAL), Pediarix (BIOLOGICAL), Engerix-B (BIOLOGICAL), ActHIB (BIOLOGICAL), Pentacel (BIOLOGICAL).
Who is sponsoring clinical trial NCT02096263?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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