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NCT02987972 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

A Phase 2 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 2
Development phase
1,051
Enrollment target
20
Study locations

NCT02987972: Completed Phase 2 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.

NCT02987972 is a Phase 2 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,051 participants, above the 800-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02987972, a Phase 2 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 2
Development phase
1,051 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \>=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.

Primary Outcome

Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.

Conditions Studied

Pneumococcal Infections

Interventions

  • BIOLOGICAL Prevnar 13™
  • BIOLOGICAL V114 Lot 1
  • BIOLOGICAL V114 Lot 2

Study Locations (20)

California

  • Premier Health Research Center, LLC ( Site 0035) - Downey
  • Sherif Khamis MD, Inc. ( Site 0044) - Palmdale
  • Kaiser Permanente - Roseville ( Site 0045) - Roseville
  • Kaiser Permanente Clinical Trial - Sacramento ( Site 0076) - Sacramento

Ohio

  • Pediatric Associates of Mt. Carmel, Inc. ( Site 0052) - Cincinnati
  • Senders Pediatrics ( Site 0058) - Cleveland
  • Ohio Pediatric Research Association ( Site 0060) - Dayton

Pennsylvania

  • Pediatric Medical Associates ( Site 0059) - East Norriton
  • Kid's Way Pediatrics ( Site 0036) - Hermitage
  • Thomas Jefferson University ( Site 0067) - Philadelphia

Alabama

  • Birmingham Pediatric Research ( Site 0043) - Birmingham
  • Southeastern Pediatric Associates, P.A. ( Site 0079) - Dothan

Kentucky

  • Kentucky Pediatric/Adult Research Inc ( Site 0037) - Bardstown
  • University of Louisville: Pediatric Clinical Trials Unit ( Site 0049) - Louisville

New York

  • Child Health Care Associates ( Site 0064) - East Syracuse
  • State University of New York Upstate Medical University ( Site 0065) - Syracuse

Arkansas

  • Children's Clinic of Jonesboro, PA ( Site 0054) - Jonesboro

Louisiana

  • ACC Pediatric Research ( Site 0039) - Haughton

Trial Details

FieldValue
Enrollment Target 1,051 participants
Start Date 2017-03-21
Est. Completion 2018-10-04
Phase Phase 2
Merck Sharp & Dohme

558 total trials

What the finished NCT02987972 record still lists

NCT02987972 is an interventional study that assigns participants to a tested intervention. Its 1,051 participants enrollment target places it among the larger protocols in the corpus, above the 800-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (31% higher).

The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 3 interventions - of which Prevnar 13™ is the first listed.

NCT02987972 names 20 study sites across 10 states, led by California, Ohio, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02987972 about?

NCT02987972 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)". This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \...

What is the current status of trial NCT02987972?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,051 participants. The study started on 2017-03-21. Estimated completion is 2018-10-04.

What conditions does trial NCT02987972 study?

This clinical trial studies the following conditions: Pneumococcal Infections.

What interventions are being tested in trial NCT02987972?

The interventions under investigation include: Prevnar 13™ (BIOLOGICAL), V114 Lot 1 (BIOLOGICAL), V114 Lot 2 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02987972?

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

Where is trial NCT02987972 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Pneumococcal Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02987972's enrollment target sits among peer trials

1,051 5th of 10 higher than 6 of 10 other Pneumococcal Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pneumococcal Infections 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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Related registry views

Source: ClinicalTrials.gov NCT02987972, the US trial registry maintained by the National Library of Medicine. NCT02987972 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.