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

NCT06838000 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: PSK00010U1111-1294-78602024-512271-13
• Study Type: interventional
• Target: 1,268
• Locations: 4 countries
• Sites: 38

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).

Conditions

Pneumococcal Infections

Keywords

Pneumococcal Vaccines; Pneumococcal Conjugate Vaccine; Healthy Participants

Outcome Measures

Primary Outcomes (8)

• Number of participants reporting immediate adverse events (AEs)

  Unsolicited (spontaneously reported) systemic AEs after each and any injection of a pneumococcal vaccine

  Within 30 minutes post-vaccination

• Number of participants reporting solicited injection site and solicited systemic reactions

  Up to Day 7 post-vaccination

• Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine

  Within 30 days after vaccination

• Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)

  SAEs and AESIs are collected throughout the study period

  From day 0 to day 517

• Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific IgG concentrations for all serotypes included in PCV21

  Ab (antibody) concentrations for each pneumococcal serotype are measured.

  On day 30 after last vaccination

• Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21

  Serotype specific OPA titers for each pneumococcal serotype are determined.

  On day 30

• Number of Children (2-5 years of age [YoA]):with serotype specific IgG concentrations for all serotypes included in PCV21

  Ab concentrations for each pneumococcal serotype are measured.

  On day 30

• Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21

  Serotype specific OPA titers for each pneumococcal serotype are determined.

  On day 30

Secondary Outcomes (6)

• Number of Children/adolescents (≥ 2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21

  On day 30

• Number of Children/adolescents (≥ 2 YoA): with serotype specific IgG concentrations for all serotypes included in PCV21

  On day 30

• Number of participants (all age groups) with serotype specific IgG concentration ≥ 0.35 μg/mL for all serotypes included in PCV21

  On day 30 after last vaccination

• Number of infants (7-11 MoA) and toddlers(12-23 MoA):with serotype specific OPA titers for all serotypes included in PCV21

  On day 30 after last vaccination

• Percentage of infants (7-11 MoA) and toddlers(12-23 MoA): with serotype specific OPA titers ≥ LLOQ for all serotypes included in PCV21

  On day 30 after last vaccination

Study Arms (3)

Infants (7 to 11 MoA)

EXPERIMENTAL

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

Biological: PCV21; Biological: 20vPCV

Toddlers (12 to 23 MoA)

EXPERIMENTAL

Participants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses

Biological: PCV21; Biological: 20vPCV

Children/adolescent (2 to 5 and 6 to 17 YoA)

EXPERIMENTAL

Participants will receive 1 intramuscular injection of the pneumococcal vaccine

Biological: PCV21; Biological: 20vPCV

Interventions

PCV21 BIOLOGICAL

Investigational pneumococcal conjugate vaccine

Children/adolescent (2 to 5 and 6 to 17 YoA); Infants (7 to 11 MoA); Toddlers (12 to 23 MoA)

20vPCV BIOLOGICAL

20-valent pneumococcal conjugate vaccine

Children/adolescent (2 to 5 and 6 to 17 YoA); Infants (7 to 11 MoA); Toddlers (12 to 23 MoA)

Eligibility Criteria

• Age: 7 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• AGE
• 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
• Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures

You may not qualify if:

• MEDICAL CONDITIONS
• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (38)

Site # 8400008

Paramount, California, 90723, United States

Location

Site # 8400024

Doral, Florida, 33166, United States

Location

Site # 8400007

Hialeah, Florida, 33012, United States

Location

Site # 8400014

Melbourne, Florida, 32934, United States

Location

Site # 8400009

Miami, Florida, 33166, United States

Location

Site # 8400016

Miami, Florida, 33166, United States

Location

Site # 8400021

Fayetteville, Georgia, 30214, United States

Location

Site # 8400004

Union City, Georgia, 30291, United States

Location

Site # 8400003

Sioux City, Iowa, 51106, United States

Location

Site # 8400023

Erlanger, Kentucky, 41018, United States

Location

Site # 8400018

Biloxi, Mississippi, 39531, United States

Location

Site # 8400012

Ridgeland, Mississippi, 39531, United States

Location

Site # 8400002

Omaha, Nebraska, 68114, United States

Location

Site #8400010

Binghamton, New York, 13905, United States

Location

Site # 8400025

Rochester, New York, 14642, United States

Location

Site # 8400001

Houston, Texas, 77065, United States

Location

Site # 8400017

Stephenville, Texas, 76401, United States

Location

Site # 2330006

Tallinn, Harju, 10117, Estonia

Location

Site # 2330007

Tallinn, Harju, 13619, Estonia

Location

Site # 2330002

Tallinn, Harju, EE-10617, Estonia

Location

Site # 2330003

Tallinn, Harju, EE-10617, Estonia

Location

Site # 2330001

Paide, Järvamaa, 72713, Estonia

Location

Site # 2330005

Tartu, Tartu, 50106, Estonia

Location

Site # 2330004

Tartu, 50708, Estonia

Location

Site # 6160009

Lodz, Lodskie, 91-341, Poland

Location

Site # 6160007

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Site # 6160003

Częstochowa, Silesian Voivodeship, 42-200, Poland

Location

Site # 6160002

Bydgoszcz, 85-048, Poland

Location

Site # 6160004

Bydgoszcz, 85-796, Poland

Location

Site # 6160006

Kłodzko, 57-300, Poland

Location

Site # 6160001

Torun, 87-100, Poland

Location

Site # 7640002

Hat Yai, Changwat Songkhla, 90112, Thailand

Location

Site # 7640003

Mueang Nonthaburi, Chiang Mai, 50200, Thailand

Location

Site # 7640008

Bangkok, 10270, Thailand

Location

Site # 7640006

Bangkok, 10400, Thailand

Location

Site # 7640007

Bangkok, 10400, Thailand

Location

Site # 7640004

Chiang Mai, 50200, Thailand

Location

Site # 7640001

Pathum Thani, Thailand

Location

Related Links

• Plain Language Results Summary

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Clinical Sciences & Operations Study Director

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Modified double-blind: * 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Control-Method: Active Controlled

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: February 20, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (7); US (17); PL (7); TH (7)