Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

NCT06736041
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
1,714
clinicaltrials.gov
Lead sponsor
Sanofi Pasteur, a Sanofi Company
clinicaltrials.gov
Start date
2024-12-18
clinicaltrials.gov
Number of sites
112
clinicaltrials.gov

Summary
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. 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.
clinicaltrials.gov
Short title
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
clinicaltrials.gov
Official title
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-05-17
clinicaltrials.gov
First posted
2024-12-16
clinicaltrials.gov
Registry last updated
2026-04-22
clinicaltrials.gov
Primary completion date
2027-05-17
clinicaltrials.gov
Start date
2024-12-18
clinicaltrials.gov

Actual participants
1,714
clinicaltrials.gov
Participants
1,714
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
112
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Sanofi Pasteur, a Sanofi Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06736041
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06736041
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
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
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Seroresponse rate for PCV21 serotypes

    Timeframe: 30 days post-dose 3

    Serotype specific IgG concentration ≥ 0.35 µg/mL

  2. IgG concentration for PCV21 serotypes

    Timeframe: 30 days post-dose 3

    Serotype specific IgG Geometric Mean Concentration (GMC)

  3. IgG concentration for PCV21 serotypes

    Timeframe: 30 days post-dose 4

    Serotype specific IgG GMC post-dose 4

  1. Anti- hepatitis B surface antigen (HBsAg) Ab

    Timeframe: 30 days post-dose 3

    % Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)

  2. Anti- polyribosylribitol phosphate (PRP) Ab

    Timeframe: 30 days post-dose 3

    % Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)

  3. Anti-poliovirus types (1, 2, and 3) Ab

    Timeframe: 30 days post-dose 3

    % Antibody titers ≥ 1:8

  4. Anti-diphtheria Ab concentrations

    Timeframe: 30 days post-dose 3

    % Antibody concentrations ≥ 0.1 IU/mL

  5. Anti-tetanus Ab concentrations

    Timeframe: 30 days post-dose 3

    % Antibody concentrations ≥ 0.1 IU/mL

  6. Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))

    Timeframe: 30 days post-dose 3

    Antibody GMC

  7. Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations

    Timeframe: 30 days post-dose 3

    Antibody GMC

  8. Anti-measles Ab concentrations

    Timeframe: 30 days post-dose 4

    % Antibody concentrations ≥ 225 milli international units per milliliter (mIU/mL)

  9. Anti-measles Ab concentrations

    Timeframe: 30 days post-dose 4

    Antibody GMC

  10. Anti-mumps Ab concentrations

    Timeframe: 30 days post-dose 4

    % Anti-mumps Ab concentrations ≥ 10 Ab units (AbU)/mL

  11. Anti-mumps Ab concentrations

    Timeframe: 30 days post-dose 4

    Antibody GMC

  12. Anti-rubella Ab concentrations

    Timeframe: 30 days post-dose 4

    % Anti-rubella Ab concentrations ≥ 10 IU/mL

  13. Anti-rubella Ab concentrations

    Timeframe: 30 days post-dose 4

    Antibody GMC

  14. Anti-varicella Ab concentrations

    Timeframe: 30 days post-dose 4

    Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL

  15. IgG concentration for the additional serotype 9N

    Timeframe: 30 days post-dose 3

    Serotype 9N specific IgG concentration ≥ 0.35 µg/mL

  16. IgG concentration for serotype 3

    Timeframe: 30 days post-dose 3

    Serotype 3 specific IgG concentration ≥ 0.35 µg/mL

  17. IgG concentration for additional serotype 9N

    Timeframe: 30 days post-dose 3

    Serotype 9N specific IgG GMC

  18. IgG concentration for serotype 3

    Timeframe: 30 days post-dose 3

    Serotype 3 specific IgG GMC

  19. Serotype 9N specific IgG GMC post-dose 4

    Timeframe: 30 days post-dose 4

    Serotype 9N specific IgG GMC post-dose 4

  20. IgG concentration for additional serotype 9N

    Timeframe: 30 days post-dose 4

    Serotype 9N specific IgG GMC post-dose 4

  21. IgG concentration for serotype 3

    Timeframe: 30 days post-dose 4

    Serotype 3 specific IgG GMC post-dose 4

  22. Seroresponse rate for PCV21 serotypes

    Timeframe: 30 days post-dose 4

    Serotype specific IgG concentration ≥ 0.35 µg/mL

  23. IgG concentration for PCV21 serotypes

    Timeframe: Before dose 4 and 30 days post-dose 4

    Serotype specific IgG GMC prior to and post-dose 4

  24. Serotype specific OPA titers for all serotypes included in PCV21

    Timeframe: 30 days post-dose 3

    Antibody GMC

  25. Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21

    Timeframe: 30 days post-dose 3

    Antibody GMC

And 6 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
89 Days
Healthy volunteers
Yes

  • 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 as assessed by the investigator

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

  • 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 vaccines being administered in the study
  • History of seizure or significant stable or progressive neurological 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 substances
  • Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable 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 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention 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.
  • Previous vaccination against S. pneumoniae
  • Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and 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.

Sources for eligibility
clinicaltrials.gov

  • Sun City Clinical Research- Site Number : 8400247Glendale, United States
  • Eclipse Clinical Research- Site Number : 8400029Tucson, United States
  • Northwest Arkansas Pediatric Clinic- Site Number : 8400030Fayetteville, United States
  • Southland Clinical Research Center- Site Number : 8400243Fountain Valley, United States
  • Century Research Institute- Site Number : 8400065Huntington Park, United States
  • Matrix Clinical Research - Huntington Park- Site Number : 8400012Huntington Park, United States
  • Matrix Clinical Research - Los Angeles- Site Number : 8400013Los Angeles, United States
  • University of California Los Angeles Medical Center- Site Number : 8400238Los Angeles, United States
  • Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259Pasadena, United States
  • FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063Ventura, United States
  • Velocity Clinical Research - Washington DC- Site Number : 8400049Washington D.C., United States
  • PAS Research- Site Number : 8400123Clearwater, United States
  • Prohealth Research Center- Site Number : 8400159Doral, United States
  • NurtureGen Research- Site Number : 8400205Homestead, United States
  • EMDA Clinical Research- Site Number : 8400237Miami, United States
  • Dade Research Center- Site Number : 8400007Miami, United States
  • Acevedo Clinical Research Associates- Site Number : 8400089Miami, United States
  • Miami Clinical Research Tower- Site Number : 8400189Miami, United States
  • Vasconcello-Cohen MD Research, LLC- Site Number : 8400248Miami, United States
  • Bio-Medical Research- Site Number : 8400147Miami, United States
  • High Quality Research- Site Number : 8400245Miami, United States
  • Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032Miami Lakes, United States
  • BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203Miami Lakes, United States
  • Optimal Research Sites- Site Number : 8400232Orange City, United States
  • SEC Clinical Research - Pensacola- Site Number : 8400003Pensacola, United States

And 87 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1294-7860
Sources for references
clinicaltrials.gov

Related records

Drugs (12)

Lead sponsors (1)