AzTrials
AzTrials

Pneumococcal ImmunizationPhase 3NCT06824181

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

A Phase 3 study testing PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine in people with Pneumococcal Immunization, run by Sanofi at 27 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Immunization
What is being tested?
PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
27 sitesin 4 countries
Study dates
27 Feb 2025to 10 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 89 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

United States17 sites

  • Helios Clinical Research - BUR PEDI- Site Number : 8400016

    Burleson, Texas, 76028

  • Carolina Family Care - Charleston- Site Number : 8400014

    Charleston, South Carolina, 29414

  • Finger Lakes Medical Research - Cortland- Site Number : 8400022

    Cortland, New York, 13045

  • Clinsearch Inc at VAST Clinical Research- Site Number : 8400028

    Euless, Texas, 76040

  • Kid's Way Pediatrics- Site Number : 8400013

    Hermitage, Pennsylvania, 16148

  • The Medici Medical Research- Site Number : 8400008

    Hollywood, Florida, 33021

  • DM Clinical Research - Houston - Jones Road- Site Number : 8400012

    Houston, Texas, 77065

  • University of Texas Medical Branch at Galveston- Site Number : 8400005

    League City, Texas, 77555

  • Private Practice - Dr. Michael W. Simon- Site Number : 8400001

    Lexington, Kentucky, 40517

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

    Los Angeles, California, 90027

  • Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027

    Miami, Florida, 33135

  • Atlantis Clinical Research- Site Number : 8400009

    Miami, Florida, 33173

  • Velocity Clinical Research - New Orleans- Site Number : 8400006

    New Orleans, Louisiana, 70119

  • University of Rochester Medical Center- Site Number : 8400019

    Rochester, New York, 14642

  • Velocity Clinical Research - Sioux City- Site Number : 8400007

    Sioux City, Iowa, 51106

  • Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024

    Stephenville, Texas, 76401

  • SUNY Upstate Medical University - Syracuse- Site Number : 8400015

    Syracuse, New York, 13210

Other trials in United States

Mexico4 sites

  • Investigational Site Number : 4840003

    León, Guanajuato, 37320

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 04530

  • Investigational Site Number : 4840002

    Temixco, Morelos, 62587

  • Investigational Site Number : 4840004

    Tlaltizapán, Morelos, 62770

Other trials in Mexico

Chile3 sites

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8380418

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8880465

Other trials in Chile

Philippines3 sites

  • Investigational Site Number : 6080001

    Cebu City, 6000

  • Investigational Site Number : 6080002

    Quezon City, 1100

  • Investigational Site Number : 6080003

    Quezon City, 1121

Other trials in Philippines

About this study

Official title: A 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

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.

Read more

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.

Being tested
PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine, Rotarix, RotaTeq

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCV21 vaccineBiological

    Also called 515

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • Prevnar 20 vaccineBiological

    Also called Prevnar20™

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • M-M-R II vaccineBiological

    Also called M-M-R™ II

    Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

  • RotarixBiological

    Also called Rotarix™

    Pharmaceutical form:Solution-Route of administration:Oral

  • RotaTeqBiological

    Also called RotaTeq™

    Pharmaceutical form:Solution-Route of administration:Oral

  • Vaxelis vaccineBiological

    Also called Vaxelis™

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • VarivaxBiological

    Also called Varivax™

    Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

  • PriorixBiological

    Also called Priorix™

    Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous

  • VAQTABiological

    Also called VAQTA™

    Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

  • HavrixBiological

    Also called Havrix™

    Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Study groups in NCT06824181
Study groupRoleWhat they receive
Group 1: 20vPCV-PCV21-PCV21-PCV21ExperimentalParticipants 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
Receives: 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
Group 2: 20vPCV-20vPCV-PCV21-PCV21ExperimentalParticipants 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
Receives: 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
20vPCV-20vPCV-20vPCV-PCV21ExperimentalParticipants 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
Receives: 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
20vPCV-20vPCV-20vPCV-20vPCVActive comparatorParticipants 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of any immediate adverse events (AEs)

    Number of participants experiencing solicited and unsolicited immediate AEs

    Measured: Within 30 minutes after each vaccination

  2. Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection

    Number of participants experiencing solicited injection site and systemic reactions

    Measured: Through 7 days after each vaccine injection

  3. Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection

    Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs

    Measured: Through 30 days after each vaccine injection

  4. Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)

    Number of participants experiencing SAEs

    Measured: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

  5. Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)

    Number of participants experiencing AESIs

    Measured: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

  6. Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4

    The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)

    Measured: 30 days PD4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start27 Feb 2025
  3. Primary completion10 Sep 2027 (estimated)
  4. Study completion10 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824181
Sponsor's protocol ID
PSK00031
Other IDs
U1111-1294-7911
Status last verified
Feb 2026
First submitted
7 Feb 2025
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine in people with Pneumococcal Immunization, run by Sanofi at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Mexico, Chile, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of any immediate adverse events (AEs) (time frame: Within 30 minutes after each vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824181.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in