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

Phase 3

Recruiting

• Conditions: Pneumococcal Immunization
• Interventions: Biological: PCV21 vaccine; Biological: Prevnar 20 vaccine; Biological: M-M-R II vaccine; Biological: Rotarix; Biological: RotaTeq; Biological: Vaxelis vaccine; Biological: Varivax; Biological: Priorix; Biological: VAQTA; Biological: Havrix

• Registration Number: NCT06824181
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-13
• Study Start: 2025-02-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2027-05-17
• Study Completion: 2027-05-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

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.
• History of seizure or significant stable or progressive neurologic disorders such as 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
• Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legal 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.
• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 20vPCV-PCV21-PCV21-PCV21	PCV21 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Prevnar 20 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	M-M-R II vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Rotarix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	RotaTeq	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Vaxelis vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Varivax	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Priorix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	VAQTA	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 1: 20vPCV-PCV21-PCV21-PCV21	Havrix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	PCV21 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Prevnar 20 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	M-M-R II vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Rotarix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	RotaTeq	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Vaxelis vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Varivax	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	VAQTA	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Havrix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	PCV21 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Prevnar 20 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	M-M-R II vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Rotarix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	RotaTeq	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Vaxelis vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Varivax	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	VAQTA	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Havrix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Prevnar 20 vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	M-M-R II vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Rotarix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	RotaTeq	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Vaxelis vaccine	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Varivax	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	VAQTA	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Havrix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
Group 2: 20vPCV-20vPCV-PCV21-PCV21	Priorix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-PCV21	Priorix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
20vPCV-20vPCV-20vPCV-20vPCV	Priorix	Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA

Primary Outcome Measures

Name	Time	Method
Presence of any immediate adverse events (AEs)	Within 30 minutes after each vaccination	Number of participants experiencing solicited and unsolicited immediate AEs
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection	Through 7 days after each vaccine injection	Number of participants experiencing solicited injection site and systemic reactions
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection	Through 30 days after each vaccine injection	Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)	Throughout the study (through 6 months post-last vaccine injection), approximately 19 months	Number of participants experiencing SAEs
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)	Throughout the study (through 6 months post-last vaccine injection), approximately 19 months	Number of participants experiencing AESIs
Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4	30 days PD4	The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)

Trial Locations

Locations (11)

The Medici Medical Research- Site Number : 8400008; 🇺🇸 Hollywood, Florida, United States

Atlantis Clinical Research, LLC- Site Number : 8400009; 🇺🇸 Miami, Florida, United States

Helios- Site Number : 8400016; 🇺🇸 Burleson, Texas, United States

Investigational Site Number : 1520001; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Velocity Clinical Research - Sioux City- Site Number : 8400007; 🇺🇸 Sioux City, Iowa, United States

Michael W. Simon, M.D., PSC- Site Number : 8400001; 🇺🇸 Lexington, Kentucky, United States

Velocity Clinical Research - New Orleans- Site Number : 8400006; 🇺🇸 New Orleans, Louisiana, United States

~SUNY Upstate Medical University- Site Number : 8400015; 🇺🇸 Syracuse, New York, United States

Kid's Way Pediatrics- Site Number : 8400013; 🇺🇸 Hermitage, Pennsylvania, United States

Kool Kids Pediatrics- Site Number : 8400012; 🇺🇸 Houston, Texas, United States

University of Texas Medical Branch at Galveston- Site Number : 8400005; 🇺🇸 League City, Texas, United States