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COMPLETED Phase 2

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

NCT02987972 · View on ClinicalTrials.gov ↗

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™.

Conditions Studied

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

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02987972

The ClinicalTrials.gov registry entry for NCT02987972 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,051 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02987972 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02987972?

The interventions under investigation include: Prevnar 13™ (BIOLOGICAL), V114 Lot 1 (BIOLOGICAL), V114 Lot 2 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02987972?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial