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NCT03239873 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
NCT03239873 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 600 participants.
The verdict
NCT03239873, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
Study Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.
Interventions
- BIOLOGICAL VARIVAX® PE34 Process
- BIOLOGICAL VARIVAX® 2016 Commercial Process
- BIOLOGICAL M-M-R II®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03239873
The ClinicalTrials.gov registry entry for NCT03239873 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which VARIVAX® PE34 Process is the first listed.
NCT03239873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03239873 about?
NCT03239873 is a clinical study titled "Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)". This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean a...
What is the current status of trial NCT03239873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2017-10-17. Estimated completion is 2019-04-02.
What interventions are being tested in trial NCT03239873?
The interventions under investigation include: VARIVAX® PE34 Process (BIOLOGICAL), VARIVAX® 2016 Commercial Process (BIOLOGICAL), M-M-R II® (BIOLOGICAL).
Who is sponsoring clinical trial NCT03239873?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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