Actively Recruiting
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Led by Sanofi · Updated on 2026-04-27
2195
Participants Needed
6
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 42 to 89 days on the day of inclusion
- Healthy based on medical evaluation including history and physical exam
- Born at full term (37 weeks or more) with birth weight at least 2.5 kg, or born between 28 and 36 weeks with birth weight at least 1.5 kg and medically stable
You will not qualify if you...
- Known or suspected immunodeficiency or receiving immunosuppressive therapy
- History of confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to routine pediatric vaccines used in the study
- History of seizure or significant neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, or cerebral palsy
- Known allergy or life-threatening reaction to study vaccine components
- Confirmed or known thrombocytopenia preventing intramuscular injections
- Bleeding disorder or recent use of anticoagulants contraindicating intramuscular injections
- Chronic illness that may interfere with study participation
- Moderate or severe acute illness or fever (temperature 38.0 0C or higher) on vaccination day
- Receipt of BCG vaccine within 4 weeks before first study vaccine or planned during study
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b, or poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood, or blood products since birth
- Participation in another clinical study involving vaccines, drugs, devices, or procedures within 6 weeks before or during this study
AI-Screening
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Trial Site Locations
Total: 6 locations
1
PAS Research - Tampa- Site Number : 8400034
Tampa, Florida, United States, 33613
Actively Recruiting
2
Michigan Institute of Research- Site Number : 8400004
Allen Park, Michigan, United States, 48101
Actively Recruiting
3
Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
Charleston, South Carolina, United States, 29407
Actively Recruiting
4
Investigational Site Number : 3400001
San Pedro Sula, Honduras, 21104
Actively Recruiting
5
Investigational Site Number : 3400002
Tegucigalpa, Honduras, 11101
Actively Recruiting
6
Investigational Site Number : 3400003
Tegucigalpa, Honduras, 11101
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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