Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
PCV21 vaccine: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
20vPCV licensed vaccine: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Study summary
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
Eligibility
Primary outcome measure(s)
- For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC) — 30 days after the third dose of PCV21 vaccine
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Northwest Arkansas Pediatric Clinic- Site Number : 8400039 | Fayetteville | Arkansas | Recruiting |
| Matrix Clinical Research - Huntington Park- Site Number : 8400029 | Huntington Park | California | Recruiting |
| Community Clinical Research- Site Number : 8400030 | Los Angeles | California | Recruiting |
| Matrix Clinical Research - Los Angeles- Site Number : 8400028 | Los Angeles | California | Recruiting |
| PAS Research - Tampa- Site Number : 8400034 | Tampa | Florida | Recruiting |
| Kentucky Pediatric Research- Site Number : 8400036 | Bardstown | Kentucky | Recruiting |
| Michigan Institute of Research- Site Number : 8400004 | Allen Park | Michigan | Recruiting |
| Nappi Wellness Institute\t- Site Number : 8400037 | Syracuse | New York | Recruiting |
| Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 | Charleston | South Carolina | Recruiting |
| Parkside Pediatrics - Simpsonville- Site Number : 8400005 | Simpsonville | South Carolina | Recruiting |
| Tribe Clinical Research - Spartanburg- Site Number : 8400026 | Spartanburg | South Carolina | Recruiting |
| PAS Research - Children's Care Clinic- Site Number : 8400035 | Edinburg | Texas | Recruiting |
| Pediatric Center - Richmond- Site Number : 8400038 | Richmond | Texas | Recruiting |
| Rio Clinical Trials - Canyon View- Site Number : 8400031 | Ogden | Utah | Recruiting |
| Investigational Site Number : 3400001 | San Pedro Sula | Honduras | Recruiting |
| Investigational Site Number : 3400002 | Tegucigalpa | Honduras | Recruiting |
| Investigational Site Number : 3400003 | Tegucigalpa | Honduras | Recruiting |
| Investigational Site Number : 6300005 | Guayama | Puerto Rico | Recruiting |
| Investigational Site Number : 6300006 | San Juan | Puerto Rico | Recruiting |
| Investigational Site Number : 6300007 | Trujillo Alto | Puerto Rico | Recruiting |
| Investigational Site Number : 7640002 | Bangkok | Thailand | Recruiting |
| Investigational Site Number : 7640004 | Chiang Mai | Thailand | Recruiting |
| Investigational Site Number : 7640003 | Hat Yai | Thailand | Recruiting |
| Investigational Site Number : 7640001 | Khon Kaen | Thailand | Recruiting |
| Investigational Site Number : 7640005 | Pathum Wan | Thailand | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07348692 on ClinicalTrials.gov ↗ ← All trials in the USA