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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: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03239873 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.
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 |
What the finished NCT03239873 record still lists
NCT03239873 is an interventional study that assigns participants to a tested intervention. The registered 600 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 (22% lower).
The record links to 0 conditions, and to 3 interventions - of which VARIVAX® PE34 Process is the first listed.
NCT03239873 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03239873's enrollment target sits among peer trials
600 608th of 2000 higher than 1,363 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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