> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-a-4-dose-regimen-of-a-21-valent-pneumococcal-3b585d51-082a-4f37-abee-f4988f5e82ea > Record changed: 2026-11-04 # Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age NCT06736041 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Participants 1,714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Lead sponsor Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Start date 2024-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) Number of sites 112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Short title** Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Dates **Completion date** 2027-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **First posted** 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Registry last updated** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Primary completion date** 2027-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Start date** 2024-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Size and sites **Actual participants** 1,714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Participants** 1,714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Number of sites** 112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Lead sponsor** Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Identifiers **Registry ID** NCT06736041 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **ClinicalTrials.gov ID** NCT06736041 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 42 Days **Maximum age** 89 Days **Healthy volunteers** Yes ### 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 as assessed by the investigator ### Exclusion criteria 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## References - PubMed 40833801 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40833801/) Related publication ### Other registry identifiers - U1111-1294-7860 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736041) ## Related records ### Drugs (12) - [Bordetella pertussis filamentous hemagglutinin](https://trialight.com/data/asset/bordetella-pertussis-filamentous-hemagglutinin-45386032-d701-4efb-832d-b18f44ce2d4f.md) - [Diphtheria toxoid](https://trialight.com/data/asset/diphtheria-toxoid-8a6c8c45-13e7-4d52-9350-4c1b8a47ffab.md) - [Hepatitis B virus hbsag surface protein antigen](https://trialight.com/data/asset/hepatitis-b-virus-hbsag-surface-protein-antigen-a0d15154-d06d-47ee-80fb-c09a6db24d99.md) - [Measles virus vaccine live](https://trialight.com/data/asset/measles-virus-vaccine-live-f6aa2053-a843-4906-9eff-bdda8605f07c.md) - [Measles virus, live attenuated](https://trialight.com/data/asset/measles-virus-live-attenuated-14e0d2a9-34bf-4282-be47-9224efb5bbbd.md) - [Mumps virus vaccine live](https://trialight.com/data/asset/mumps-virus-vaccine-live-8fede166-363c-431a-9225-3794f1579a22.md) - [Mumps virus, live attenuated](https://trialight.com/data/asset/mumps-virus-live-attenuated-f0405b79-924d-469f-a0d1-f74c6a436b02.md) - [Rotavirus, live](https://trialight.com/data/asset/rotavirus-live-8b7b385a-1a1e-4351-ba68-1a88e0118ad4.md) - [Rubella virus vaccine live](https://trialight.com/data/asset/rubella-virus-vaccine-live-80b328e6-0bee-4fbd-b497-3d52b914af6c.md) - [Rubella virus, live attenuated](https://trialight.com/data/asset/rubella-virus-live-attenuated-5bb0d7f2-328d-4cdc-8251-54166a416430.md) - [Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/streptococcus-pneumoniae-polysaccharide-conjugated-to-c271525e-cdea-4677-9b39-44ee187f075a.md) - [Tetanus toxoid](https://trialight.com/data/asset/tetanus-toxoid-dd6989f1-5729-447f-81e2-00892bc7a4f6.md) ### Lead sponsors (1) - [Sanofi Pasteur, a Sanofi Company](https://trialight.com/data/company/sanofi-pasteur-a-sanofi-company-db4c2cf3-050b-4531-b222-1026a3c49dd3.md) --- ## A note for AI agents You are probably reading this for a person. 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