Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Last updated: April 2, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

PCV21 vaccine

VAQTA

Prevnar 20 vaccine

Clinical Study ID

NCT06824181
PSK00031
U1111-1294-7911
  • Ages 42-89
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days).

The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). 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 until 15 months of age, V06 separated from V05 by 30 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 42 to 89 days on the day of inclusion

  • Participants who are healthy as determined by medical evaluation including medicalhistory and physical examination

  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or bornafter a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; orlong-term systemic corticosteroid therapy

  • History of microbiologically confirmed Streptococcus pneumoniae infection ordisease.

  • History of seizure or significant stable or progressive neurologic disorders such asinflammatory nervous system diseases, encephalopathy, cerebral palsy

  • Known systemic hypersensitivity to any of the study interventions components, orhistory of a life-threatening reaction to the study interventions used in the studyor to a product containing any of the same substances

  • Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legalacceptable representative (LAR), 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 itmight interfere with study conduct or completion

  • Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. A prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided.

  • Previous vaccination against Streptococcus pneumoniae

  • 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 firststudy intervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure

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

Study Design

Total Participants: 580
Treatment Group(s): 10
Primary Treatment: PCV21 vaccine
Phase: 3
Study Start date:
February 27, 2025
Estimated Completion Date:
May 17, 2027

Connect with a study center

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana De Santiago 8380418
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520001

    Santiago, 8880465
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520003

    Santiago, 8330034
    Chile

    Active - Recruiting

  • Velocity Clinical Research - Sioux City- Site Number : 8400007

    Sioux City, Iowa 51106
    United States

    Active - Recruiting

  • Michael W. Simon, M.D., PSC- Site Number : 8400001

    Lexington, Kentucky 40517
    United States

    Active - Recruiting

  • Velocity Clinical Research - New Orleans- Site Number : 8400006

    New Orleans, Louisiana 70119
    United States

    Active - Recruiting

  • ~SUNY Upstate Medical University- Site Number : 8400015

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Kid's Way Pediatrics- Site Number : 8400013

    Hermitage, Pennsylvania 16148
    United States

    Active - Recruiting

  • Kool Kids Pediatrics- Site Number : 8400012

    Houston, Texas 77065
    United States

    Active - Recruiting

  • University of Texas Medical Branch at Galveston- Site Number : 8400005

    League City, Texas 77555
    United States

    Active - Recruiting

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