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NCT03692871 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,409
- Enrollment target
NCT03692871: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03692871 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,409 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (212% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03692871, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,409 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,409 participants |
| Start Date | 2018-12-14 |
| Est. Completion | 2021-03-26 |
| Phase | Phase 3 |
What the finished NCT03692871 record still lists
NCT03692871 is an interventional study that assigns participants to a tested intervention. Its 2,409 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 (212% higher).
The record links to 0 conditions, and to 2 interventions - of which V114 is the first listed.
NCT03692871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03692871 about?
NCT03692871 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)". This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogen...
What is the current status of trial NCT03692871?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,409 participants. The study started on 2018-12-14. Estimated completion is 2021-03-26.
What interventions are being tested in trial NCT03692871?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT03692871?
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 NCT03692871's enrollment target sits among peer trials
2,409 89th of 2000 higher than 1,912 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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