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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 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.
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™.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,051 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2018-10-04 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 1,051 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 800-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (31% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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