Comparing three production lots of a 21‑valent pneumococcal vaccine in infants

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

This trial will test if three different production lots of a 21‑valent pneumococcal vaccine give similar immune responses and are as safe as the licensed 20‑valent vaccine when given to infants starting at about 2 months of age.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2195 (estimated)
• Ages: 42 Days to 89 Days
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Tampa, Florida and 5 other locations)
• Trial ID: NCT07348692 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, modified double‑blind study designed to show lot‑to‑lot consistency of an investigational 21‑valent pneumococcal conjugate vaccine (PCV21) and to compare its safety and immunogenicity with a licensed 20‑valent vaccine. Infants are enrolled at about 2 months of age and receive vaccinations at approximately 2, 4, 6 and 12 months, with routine pediatric vaccines given per local guidelines. Cohort A randomizes participants to one of three PCV21 manufacturing lots or to the 20‑valent comparator, while Cohort B randomizes to the three PCV21 lots only. Each participant is followed for up to about 17 months to collect immune response and safety data.

Who should consider this trial

Good fit: Healthy infants aged 42 to 89 days at enrollment who were born at or near term (or medically stable preterm as specified), with no known immunodeficiency or contraindication to routine pediatric vaccines are ideal candidates.

Not a fit: Infants with known or suspected immunodeficiency, prior microbiologically confirmed pneumococcal disease, contraindications to routine vaccines, or significant neurologic disorders are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, a consistent 21‑valent vaccine could offer broader protection against pneumococcal serotypes and provide an additional reliable option for infant immunization.

How similar studies have performed: Higher‑valent pneumococcal conjugate vaccines (including 20‑valent formulations) have been licensed and shown immunogenicity and effectiveness, and lot‑consistency testing is a standard regulatory requirement, but PCV21 itself is a newer formulation with limited public outcome data.

Eligibility criteria

Inclusion Criteria:

* Aged 42 to 89 days on the day of inclusion
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable

Exclusion Criteria:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
* History of microbiologically confirmed Streptococcus pneumoniae infection or disease
* Any contraindication to the routine pediatric vaccine being administered in the study
* History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
* Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
* Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration.
* Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
* Previous vaccination against Streptococcus pneumoniae
* Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
* Receipt of more than 1 dose of hepatitis B vaccine
* Receipt of immune globulins, blood or blood-derived products since birth
* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where this trial is running

Tampa, Florida and 5 other locations

• PAS Research - Tampa- Site Number : 8400034 — Tampa, Florida, United States (Recruiting)
• Michigan Institute of Research- Site Number : 8400004 — Allen Park, Michigan, United States (Recruiting)
• Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 — Charleston, South Carolina, United States (Recruiting)
• Investigational Site Number : 3400001 — San Pedro Sula, Honduras (Recruiting)
• Investigational Site Number : 3400002 — Tegucigalpa, Honduras (Recruiting)
• Investigational Site Number : 3400003 — Tegucigalpa, Honduras (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Pneumococcal Immunization; Healthy Volunteers; Pneumococcal Infection; 21 Valent Pneumococcal Vaccine