Suspended

21-valent and 20-valent Pneumococcal Vaccines in Infants

What is being tested

PCV21 vaccine

+ Prevnar 20 vaccine

+ M-M-R II vaccine

Biological

Who is being recruted

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3

Interventional

Study Start: February 2025

See protocol details

Summary

Principal SponsorSanofi

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 27, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring the safety and effectiveness of a new pneumococcal vaccine, called PCV21, in helping infants' bodies create antibodies to fight infections. It compares different schedules of the PCV21 vaccine with an already licensed 20-valent pneumococcal vaccine. The study focuses on healthy infants starting from about two months old. The main goal is to see if the PCV21 vaccine, given in one to three doses, works as well or better than the existing vaccine schedule in boosting the immune system. This research is important because it could enhance protection against pneumococcal diseases in young children. Participants in the study will receive doses of either the new PCV21 vaccine or the 20-valent vaccine at approximately 2, 4, 6, and between 12 to 15 months of age. The study involves six visits, spaced out over 19 months, to monitor how well the vaccines work and any reactions to them. During these visits, researchers will check the infants' health and collect data on the immune response generated by the vaccines. The study aims to ensure the vaccines are safe and effective for preventing serious infections in young children.

Official TitleA Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

NCT06824181

Principal SponsorSanofi

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

580 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

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

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

11 exclusion criteria prevent from participating

Receipt of immune globulins, blood or blood-derived products since birth

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.

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

Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

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 III

Experimental

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 IV

Active Comparator

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Suspended

Investigational Site Number : 6080002

Quezon City, PhilippinesOpen Investigational Site Number : 6080002 in Google Maps

Suspended

Investigational Site Number : 6080003

Quezon City, Philippines

Suspended

Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025

Los Angeles, United States

Suspended

The Medici Medical Research- Site Number : 8400008

Hollywood, United States

Suspended27 Study Centers