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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02096263 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 585 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
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 |
What the finished NCT02096263 record still lists
NCT02096263 is an interventional study that assigns participants to a tested intervention. The registered 585 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 5 interventions - of which Infanrix hexa is the first listed.
NCT02096263 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02096263's enrollment target sits among peer trials
585 651st of 2000 higher than 1,349 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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