Recruiting
Phase 3

PCV21

Sponsor:

Sanofi

Code:

NCT07348692

Conditions

Pneumococcal Immunization

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

PCV21 vaccine

20vPCV licensed vaccine

Study Details

Brief 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

Conditions

Pneumococcal Immunization

Healthy Volunteers

Study ID

NCT07348692

Start date

Jan 20, 2026

Status verified date

May, 2026

Completion date

May 29, 2028

Anticipated

Primary completion date

Jun 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2195 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1: PCV21

Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

experimental: Group 2: PCV21

Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

experimental: Group 3: PCV21

Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

active comparator: Group 4: 20vPCV (Cohort A only)

Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

Interventions

PCV21 vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

20vPCV licensed vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Primary outcome measure

  • For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 30 days after the third dose of PCV21 vaccine ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Northwest Arkansas Pediatric Clinic- Site Number : 8400039

Recruiting

Fayetteville, Arkansas, United States, 72703

Matrix Clinical Research - Huntington Park- Site Number : 8400029

Recruiting

Huntington Park, California, United States, 90255

Community Clinical Research- Site Number : 8400030

Recruiting

Los Angeles, California, United States, 90008

Matrix Clinical Research - Los Angeles- Site Number : 8400028

Recruiting

Los Angeles, California, United States, 90057

PAS Research - Tampa- Site Number : 8400034

Recruiting

Tampa, Florida, United States, 33613

Kentucky Pediatric Research- Site Number : 8400036

Recruiting

Bardstown, Kentucky, United States, 40004

Michigan Institute of Research- Site Number : 8400004

Recruiting

Allen Park, Michigan, United States, 48101

Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008

Recruiting

Charleston, South Carolina, United States, 29407

Parkside Pediatrics - Simpsonville- Site Number : 8400005

Recruiting

Simpsonville, South Carolina, United States, 29681

Tribe Clinical Research - Spartanburg- Site Number : 8400026

Recruiting

Spartanburg, South Carolina, United States, 29301

PAS Research - Children's Care Clinic- Site Number : 8400035

Recruiting

Edinburg, Texas, United States, 78539

Pediatric Center - Richmond- Site Number : 8400038

Recruiting

Richmond, Texas, United States, 77469

Rio Clinical Trials - Canyon View- Site Number : 8400031

Recruiting

Ogden, Utah, United States, 84404

More Information

Sponsor

Sanofi

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Pneumococcal Infection
  • 21 Valent Pneumococcal Vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-05-22.