Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
NCT ID: NCT06838000
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1268 participants
INTERVENTIONAL
2025-02-28
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
* Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff
* No blinding for vaccine group assignment: those preparing and administering the study interventions
Study Groups
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Infants (7 to 11 MoA)
Participants will receive 3 intramuscular injections of pneumococcal vaccine with an interval of:
* 4 to 8 weeks (28 to 56 days) between the 1st dose and the 2nd dose
* 8 to 12 weeks (56 to 84 days) between the 2nd dose and the 3rd dose AND age ≥ 12 MoA at 3rd dose
PCV21
Investigational pneumococcal conjugate vaccine
20vPCV
20-valent pneumococcal conjugate vaccine
Toddlers (12 to 23 MoA)
Participants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses
PCV21
Investigational pneumococcal conjugate vaccine
20vPCV
20-valent pneumococcal conjugate vaccine
Children/adolescent (2 to 5 and 6 to 17 YoA)
Participants will receive 1 intramuscular injection of the pneumococcal vaccine
PCV21
Investigational pneumococcal conjugate vaccine
20vPCV
20-valent pneumococcal conjugate vaccine
Interventions
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PCV21
Investigational pneumococcal conjugate vaccine
20vPCV
20-valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Aged 7 months to 17 years on the day of inclusion
TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only
* 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 as assessed by the investigator
SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS For adolescents (6 to 17 YoA) only
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR
* Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
INFORMED CONSENT
* Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
OTHER INCLUSIONS
* Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
* History of microbiologically confirmed S. pneumoniae infection or disease
* History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances
* Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / 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 vaccine administration.
For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only
* Previous vaccination against S. pneumonia
For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only
* Previous vaccination with pneumococcal polysaccharide vaccine
For adolescents (6 to 17 YoA) only
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
PRIOR/CONCOMITANT THERAPY
* Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
* Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
OTHER EXCLUSIONS For adolescents (6 to 17 YoA) only
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
7 Months
17 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations Study Director
Role: STUDY_DIRECTOR
Sanofi
Locations
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Site # 8400008
Paramount, California, United States
Site # 8400024
Doral, Florida, United States
Site # 8400007
Hialeah, Florida, United States
Site # 8400014
Melbourne, Florida, United States
Site # 8400009
Miami, Florida, United States
Site # 8400016
Miami, Florida, United States
Site # 8400021
Fayetteville, Georgia, United States
Site # 8400004
Union City, Georgia, United States
Site # 8400003
Sioux City, Iowa, United States
Site # 8400023
Erlanger, Kentucky, United States
Site # 8400018
Biloxi, Mississippi, United States
Site # 8400012
Ridgeland, Mississippi, United States
Site # 8400002
Omaha, Nebraska, United States
Site #8400010
Binghamton, New York, United States
Site # 8400025
Rochester, New York, United States
Site # 8400001
Houston, Texas, United States
Site # 8400017
Stephenville, Texas, United States
Site # 2330006
Tallinn, Harju, Estonia
Site # 2330007
Tallinn, Harju, Estonia
Site # 2330002
Tallinn, Harju, Estonia
Site # 2330003
Tallinn, Harju, Estonia
Site # 2330001
Paide, Järvamaa, Estonia
Site # 2330005
Tartu, Tartu, Estonia
Site # 2330004
Tartu, , Estonia
Site # 6160009
Lodz, Lodskie, Poland
Site # 6160007
Warsaw, Masovian Voivodeship, Poland
Site # 6160003
Częstochowa, Silesian Voivodeship, Poland
Site # 6160002
Bydgoszcz, , Poland
Site # 6160004
Bydgoszcz, , Poland
Site # 6160006
Kłodzko, , Poland
Site # 6160001
Torun, , Poland
Site # 7640002
Hat Yai, Changwat Songkhla, Thailand
Site # 7640003
Mueang Nonthaburi, Chiang Mai, Thailand
Site # 7640008
Bangkok, , Thailand
Site # 7640006
Bangkok, , Thailand
Site # 7640007
Bangkok, , Thailand
Site # 7640004
Chiang Mai, , Thailand
Site # 7640001
Pathum Thani, , Thailand
Countries
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Related Links
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Plain Language Results Summary
Other Identifiers
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U1111-1294-7860
Identifier Type: OTHER
Identifier Source: secondary_id
2024-512271-13
Identifier Type: OTHER
Identifier Source: secondary_id
PSK00010
Identifier Type: -
Identifier Source: org_study_id
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