A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Completed · Phase 2
Conditions studied: Pneumococcal Infections
In brief
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™.
Key facts
- Study ID
- NCT02987972
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 1051
- Starts
- 2017-03-21
- Expected to finish
- 2018-10-04
- Last updated by the study team
- 2019-10-23
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Infant approximately 2 months of age (42 days to 90 days), inclusive
- In good health
You may not qualify if…
- Prior administration of any pneumococcal vaccine
- Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency (eg, splenomegaly)
- Mother has documented human immunodeficiency virus (HIV) infection
- Mother has documented hepatitis B surface antigen-positive test result
- Known or history of functional or anatomic asplenia
- History of failure to thrive
- History of a coagulation disorder
- History of autoimmune disease
- Known neurologic or cognitive behavioral disorder
- Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
- Prior administration of a blood transfusion or blood products, including immunoglobulin
- Participated in another clinical trial of an investigational product
- History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Where it is running
- Birmingham Pediatric Research ( Site 0043) — Birmingham, Alabama, United States
- Southeastern Pediatric Associates, P.A. ( Site 0079) — Dothan, Alabama, United States
- Children's Clinic of Jonesboro, PA ( Site 0054) — Jonesboro, Arkansas, United States
- Premier Health Research Center, LLC ( Site 0035) — Downey, California, United States
- Sherif Khamis MD, Inc. ( Site 0044) — Palmdale, California, United States
- Kaiser Permanente - Roseville ( Site 0045) — Roseville, California, United States
- Kaiser Permanente Clinical Trial - Sacramento ( Site 0076) — Sacramento, California, United States
- Kentucky Pediatric/Adult Research Inc ( Site 0037) — Bardstown, Kentucky, United States
- University of Louisville: Pediatric Clinical Trials Unit ( Site 0049) — Louisville, Kentucky, United States
- ACC Pediatric Research ( Site 0039) — Haughton, Louisiana, United States
- Woburn Pediatric Associates ( Site 0046) — Woburn, Massachusetts, United States
- Dundee Clinic ( Site 0063) — Omaha, Nebraska, United States
- Child Health Care Associates ( Site 0064) — East Syracuse, New York, United States
- State University of New York Upstate Medical University ( Site 0065) — Syracuse, New York, United States
- Pediatric Associates of Mt. Carmel, Inc. ( Site 0052) — Cincinnati, Ohio, United States
- Senders Pediatrics ( Site 0058) — Cleveland, Ohio, United States
- Ohio Pediatric Research Association ( Site 0060) — Dayton, Ohio, United States
- Pediatric Medical Associates ( Site 0059) — East Norriton, Pennsylvania, United States
- Kid's Way Pediatrics ( Site 0036) — Hermitage, Pennsylvania, United States
- Thomas Jefferson University ( Site 0067) — Philadelphia, Pennsylvania, United States
- Coastal Pediatric Research ( Site 0070) — Charleston, South Carolina, United States
- Holston Medical Group [Kingsport, TN] ( Site 0048) — Kingsport, Tennessee, United States
- University of Texas Medical Branch at Galveston ( Site 0056) — Galveston, Texas, United States
- University of Texas Medical Branch at Galveston ( Site 0068) — League City, Texas, United States
- Wee Care Pediatrics ( Site 0042) — Layton, Utah, United States
Full record on ClinicalTrials.gov
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