Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Public ClinicalTrials.gov record NCT07348692. 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 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07348692
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 42 Days to 89 Days
- 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
- Jan 19, 2026
- Primary completion
- Jun 6, 2027
- Completion
- May 28, 2028
- Last update posted
- May 21, 2026
2026 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwest Arkansas Pediatric Clinic- Site Number : 8400039 | Fayetteville | Arkansas | 72703 | Recruiting |
| Matrix Clinical Research - Huntington Park- Site Number : 8400029 | Huntington Park | California | 90255 | Recruiting |
| Community Clinical Research- Site Number : 8400030 | Los Angeles | California | 90008 | Recruiting |
| Matrix Clinical Research - Los Angeles- Site Number : 8400028 | Los Angeles | California | 90057 | Recruiting |
| PAS Research - Tampa- Site Number : 8400034 | Tampa | Florida | 33613 | Recruiting |
| Kentucky Pediatric Research- Site Number : 8400036 | Bardstown | Kentucky | 40004 | Recruiting |
| Michigan Institute of Research- Site Number : 8400004 | Allen Park | Michigan | 48101 | Recruiting |
| Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 | Charleston | South Carolina | 29407 | Recruiting |
| Parkside Pediatrics - Simpsonville- Site Number : 8400005 | Simpsonville | South Carolina | 29681 | Recruiting |
| Tribe Clinical Research - Spartanburg- Site Number : 8400026 | Spartanburg | South Carolina | 29301 | Recruiting |
| PAS Research - Children's Care Clinic- Site Number : 8400035 | Edinburg | Texas | 78539 | Recruiting |
| Pediatric Center - Richmond- Site Number : 8400038 | Richmond | Texas | 77469 | Recruiting |
| Rio Clinical Trials - Canyon View- Site Number : 8400031 | Ogden | Utah | 84404 | Recruiting |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07348692, 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 May 21, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07348692 live on ClinicalTrials.gov.