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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwest Arkansas Pediatric Clinic- Site Number : 8400039
  Fayetteville, Arkansas, United States Recruiting
• Matrix Clinical Research - Huntington Park- Site Number : 8400029
  Huntington Park, California, United States Recruiting
• Community Clinical Research- Site Number : 8400030
  Los Angeles, California, United States Recruiting
• Matrix Clinical Research - Los Angeles- Site Number : 8400028
  Los Angeles, California, United States Recruiting
• PAS Research - Tampa- Site Number : 8400034
  Tampa, Florida, United States Recruiting
• Kentucky Pediatric Research- Site Number : 8400036
  Bardstown, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.