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NCT03207750 · ClinicalTrials.gov registry record · Phase 3
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,280
- Enrollment target
NCT03207750: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03207750 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,280 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03207750, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,280 participants
- Enrollment target
Study Summary
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
Primary Outcome
Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.
Interventions
- BIOLOGICAL Rotarix
- BIOLOGICAL Pediarix
- BIOLOGICAL Hiberix
- BIOLOGICAL Prevenar 13
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,280 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 3 |
What the finished NCT03207750 record still lists
NCT03207750 is an interventional study that assigns participants to a tested intervention. Its 1,280 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 (66% higher).
The record links to 0 conditions, and to 4 interventions - of which Rotarix is the first listed.
NCT03207750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03207750 about?
NCT03207750 is a clinical study titled "This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine". The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed...
What is the current status of trial NCT03207750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,280 participants. The study started on 2017-09-14. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT03207750?
The interventions under investigation include: Rotarix (BIOLOGICAL), Pediarix (BIOLOGICAL), Hiberix (BIOLOGICAL), Prevenar 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03207750?
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 NCT03207750's enrollment target sits among peer trials
1,280 198th of 2000 higher than 1,801 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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