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NCT03731182 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

A Phase 3 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 3
Development phase
104
Enrollment target

NCT03731182: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.

NCT03731182 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03731182, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 3
Development phase
104 participants
Enrollment target

Study Summary

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

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

FieldValue
Enrollment Target 104 participants
Start Date 2019-01-23
Est. Completion 2020-06-08
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the finished NCT03731182 record still lists

NCT03731182 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (87% lower).

The record links to 0 conditions, and to 2 interventions - of which V114 is the first listed.

NCT03731182 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03731182 about?

NCT03731182 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)". This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

What is the current status of trial NCT03731182?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2019-01-23. Estimated completion is 2020-06-08.

What interventions are being tested in trial NCT03731182?

The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL).

Who is sponsoring clinical trial NCT03731182?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03731182's enrollment target sits among peer trials

104 1671st of 2000 higher than 327 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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Source: ClinicalTrials.gov NCT03731182, the US trial registry maintained by the National Library of Medicine. NCT03731182 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.