A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Public ClinicalTrials.gov record NCT02987972. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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™.
Study identification
- NCT ID
- NCT02987972
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,051 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Weeks to 12 Weeks
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2017
- Primary completion
- Oct 3, 2018
- Completion
- Oct 3, 2018
- Last update posted
- Oct 22, 2019
2017 – 2018
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pediatric Research ( Site 0043) | Birmingham | Alabama | 35205 | — |
| Southeastern Pediatric Associates, P.A. ( Site 0079) | Dothan | Alabama | 36305 | — |
| Children's Clinic of Jonesboro, PA ( Site 0054) | Jonesboro | Arkansas | 72401 | — |
| Premier Health Research Center, LLC ( Site 0035) | Downey | California | 90241 | — |
| Sherif Khamis MD, Inc. ( Site 0044) | Palmdale | California | 93550 | — |
| Kaiser Permanente - Roseville ( Site 0045) | Roseville | California | 95661 | — |
| Kaiser Permanente Clinical Trial - Sacramento ( Site 0076) | Sacramento | California | 95815 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0037) | Bardstown | Kentucky | 40004 | — |
| University of Louisville: Pediatric Clinical Trials Unit ( Site 0049) | Louisville | Kentucky | 40202 | — |
| ACC Pediatric Research ( Site 0039) | Haughton | Louisiana | 71037 | — |
| Woburn Pediatric Associates ( Site 0046) | Woburn | Massachusetts | 01801 | — |
| Dundee Clinic ( Site 0063) | Omaha | Nebraska | 68132 | — |
| Child Health Care Associates ( Site 0064) | East Syracuse | New York | 13057 | — |
| State University of New York Upstate Medical University ( Site 0065) | Syracuse | New York | 13210 | — |
| Pediatric Associates of Mt. Carmel, Inc. ( Site 0052) | Cincinnati | Ohio | 45245 | — |
| Senders Pediatrics ( Site 0058) | Cleveland | Ohio | 44121 | — |
| Ohio Pediatric Research Association ( Site 0060) | Dayton | Ohio | 45414 | — |
| Pediatric Medical Associates ( Site 0059) | East Norriton | Pennsylvania | 19401 | — |
| Kid's Way Pediatrics ( Site 0036) | Hermitage | Pennsylvania | 16148 | — |
| Thomas Jefferson University ( Site 0067) | Philadelphia | Pennsylvania | 19107 | — |
| Coastal Pediatric Research ( Site 0070) | Charleston | South Carolina | 29414 | — |
| Holston Medical Group [Kingsport, TN] ( Site 0048) | Kingsport | Tennessee | 37660 | — |
| University of Texas Medical Branch at Galveston ( Site 0056) | Galveston | Texas | 77555 | — |
| University of Texas Medical Branch at Galveston ( Site 0068) | League City | Texas | 77573 | — |
| Wee Care Pediatrics ( Site 0042) | Layton | Utah | 84041 | — |
| Cottonwood Pediatrics ( Site 0041) | Murray | Utah | 84107 | — |
| Copperview Medical Center ( Site 0062) | South Jordan | Utah | 84095 | — |
| Pediatric Research of Charlottesville, LLC ( Site 0066) | Charlottesville | Virginia | 22902 | — |
| Huguenot Pediatrics ( Site 0057) | Midlothian | Virginia | 23113 | — |
| Family Health Care of Ellensburg ( Site 0077) | Ellensburg | Washington | 98926 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02987972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02987972 live on ClinicalTrials.gov.