Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

Completed · Phase 3

Conditions studied: Pneumococcal Infections, Pneumococcal Vaccines

In brief

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Key facts

Study ID

NCT03893448

Run by

Merck Sharp & Dohme LLC

People needed

1720

Starts

2019-06-19

Expected to finish

2021-05-24

Last updated by the study team

2023-07-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
• Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

You may not qualify if…

• Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
• Has any contraindication to the concomitant study vaccines being administered in the study.
• Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.

Where it is running

• Southeastern Pediatric Associates, P.A. ( Site 0107) — Dothan, Alabama, United States
• South Alabama Pediatrics ( Site 0263) — Opp, Alabama, United States
• Northwest Arkansas Pediatric Clinic ( Site 0172) — Fayetteville, Arkansas, United States
• Children's Clinic of Jonesboro, PA ( Site 0184) — Jonesboro, Arkansas, United States
• Advanced Clinical Research - Rancho Paseo ( Site 0163) — Banning, California, United States
• Altissima Clinical Research LLC ( Site 0213) — Bellflower, California, United States
• Southland Clinical Research Center ( Site 0187) — Bellflower, California, United States
• Premier Health Research Center, LLC ( Site 0121) — Downey, California, United States
• Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282) — Oakland, California, United States
• Kaiser Permanente - Sacramento ( Site 0257) — Sacramento, California, United States
• Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256) — Sacramento, California, United States
• Kaiser Permanente - San Jose ( Site 0258) — San Jose, California, United States
• Kaiser Permanente - Santa Clara ( Site 0244) — Santa Clara, California, United States
• Davita Medical Group ( Site 0141) — Colorado Springs, Colorado, United States
• Suncoast Research Associates, LLC ( Site 0250) — Miami, Florida, United States
• Suncoast Research Associates, LLC ( Site 0249) — North Miami Beach, Florida, United States
• Children's Health Center ( Site 0272) — Tampa, Florida, United States
• Saltzer Medical Group ( Site 0215) — Nampa, Idaho, United States
• Kentucky Pediatric/Adult Research Inc ( Site 0136) — Bardstown, Kentucky, United States
• Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276) — Nicholasville, Kentucky, United States
• ACC Pediatric Research ( Site 0147) — Haughton, Louisiana, United States
• Medpharmics, LLC ( Site 0157) — Metairie, Louisiana, United States
• Virgo-Carter Pediatrics ( Site 0275) — Silver Spring, Maryland, United States
• Tufts Medical Center-Floating Hospital for Children ( Site 0129) — Boston, Massachusetts, United States
• Alabama Clinical Therapeutics ( Site 0159) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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