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Pneumococcal InfectionsPhase 3NCT06838000

Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents

A Phase 3 study testing PCV21 and 20vPCV in people with Pneumococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 38 sites in 4 countries.

Active, not recruiting

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age). Read more about this study

Who is it for?
Ages 7 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infections
What is being tested?
PCV21 and 20vPCV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,268 participants
Where
38 sitesin 4 countries
Study dates
28 Feb 2025to 1 Dec 2026
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 7 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • AGE
  • Aged 7 months to 17 years on the day of inclusion
  • TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only
  • 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
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  • SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS For adolescents (6 to 17 YoA) only
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR
  • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
  • INFORMED CONSENT
  • Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
  • OTHER INCLUSIONS
  • Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures

Who cannot join

  • MEDICAL CONDITIONS
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
  • History of microbiologically confirmed S. pneumoniae infection or disease
  • History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances
  • Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / LAR(s), contraindicating intramuscular (IM) injection
Show all 26Show 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 vaccine administration.
  • For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only
  • Previous vaccination against S. pneumonia
  • For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only
  • Previous vaccination with pneumococcal polysaccharide vaccine
  • For adolescents (6 to 17 YoA) only
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
  • PRIOR/CONCOMITANT THERAPY
  • Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine 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
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
  • Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • OTHER EXCLUSIONS For adolescents (6 to 17 YoA) only
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial locations and contacts

38 sites in 4 countries.

38 sites in 4 countries

United States17 sites

  • Site # 8400018

    Biloxi, Mississippi, 39531

  • Site #8400010

    Binghamton, New York, 13905

  • Site # 8400024

    Doral, Florida, 33166

  • Site # 8400023

    Erlanger, Kentucky, 41018

  • Site # 8400021

    Fayetteville, Georgia, 30214

  • Site # 8400007

    Hialeah, Florida, 33012

  • Site # 8400001

    Houston, Texas, 77065

  • Site # 8400014

    Melbourne, Florida, 32934

  • Site # 8400009

    Miami, Florida, 33166

  • Site # 8400016

    Miami, Florida, 33166

  • Site # 8400002

    Omaha, Nebraska, 68114

  • Site # 8400008

    Paramount, California, 90723

  • Site # 8400012

    Ridgeland, Mississippi, 39531

  • Site # 8400025

    Rochester, New York, 14642

  • Site # 8400003

    Sioux City, Iowa, 51106

  • Site # 8400017

    Stephenville, Texas, 76401

  • Site # 8400004

    Union City, Georgia, 30291

Other trials in United States

Estonia7 sites

  • Site # 2330001

    Paide, Järvamaa, 72713

  • Site # 2330006

    Tallinn, Harju, 10117

  • Site # 2330007

    Tallinn, Harju, 13619

  • Site # 2330002

    Tallinn, Harju, EE-10617

  • Site # 2330003

    Tallinn, Harju, EE-10617

  • Site # 2330005

    Tartu, Tartu, 50106

  • Site # 2330004

    Tartu, 50708

Other trials in Estonia

Poland7 sites

  • Site # 6160002

    Bydgoszcz, 85-048

  • Site # 6160004

    Bydgoszcz, 85-796

  • Site # 6160003

    Częstochowa, Silesian Voivodeship, 42-200

  • Site # 6160006

    Kłodzko, 57-300

  • Site # 6160009

    Lodz, Lodskie, 91-341

  • Site # 6160001

    Torun, 87-100

  • Site # 6160007

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Thailand7 sites

  • Site # 7640008

    Bangkok, 10270

  • Site # 7640006

    Bangkok, 10400

  • Site # 7640007

    Bangkok, 10400

  • Site # 7640004

    Chiang Mai, 50200

  • Site # 7640002

    Hat Yai, Changwat Songkhla, 90112

  • Site # 7640003

    Mueang Nonthaburi, Chiang Mai, 50200

  • Site # 7640001

    Pathum Thani

Other trials in Thailand

About this study

Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group Study to Investigate the Safety and Immunogenicity of Catch-up Vaccination Regimens of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).

Read the detailed description

The duration of each participation will be approximately 9 to 11 months for each infant participant, 8 to 9 months for each toddler participant, and 6 months for each child/adolescent participant.

Being tested
PCV21, 20vPCV
Keywords
Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine, Healthy Participants
Medical subject headings
Pneumococcal Infections

What participants receive

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

  • PCV21Biological

    Investigational pneumococcal conjugate vaccine

  • 20vPCVBiological

    20-valent pneumococcal conjugate vaccine

Study groups in NCT06838000
Study groupRoleWhat they receive
Infants (7 to 11 MoA)ExperimentalParticipants will receive 3 intramuscular injections of pneumococcal vaccine with an interval of: * 4 to 8 weeks (28 to 56 days) between the 1st dose and the 2nd dose * 8 to 12 weeks (56 to 84 days) between the 2nd dose and the 3rd dose AND age ≥ 12 MoA at 3rd dose
Receives: Biological: PCV21; Biological: 20vPCV
Toddlers (12 to 23 MoA)ExperimentalParticipants will receive 2 intramuscular injections of the pneumococcal vaccine with an interval of 8 to 12 weeks (56 to 84 days) between doses
Receives: Biological: PCV21; Biological: 20vPCV
Children/adolescent (2 to 5 and 6 to 17 YoA)ExperimentalParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Receives: Biological: PCV21; Biological: 20vPCV

What is being measured

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

  1. Number of participants reporting immediate adverse events (AEs)

    Unsolicited (spontaneously reported) systemic AEs after each and any injection of a pneumococcal vaccine

    Measured: Within 30 minutes post-vaccination

  2. Number of participants reporting solicited injection site and solicited systemic reactions

    Measured: Up to Day 7 post-vaccination

  3. Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine

    Measured: Within 30 days after vaccination

  4. Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)

    SAEs and AESIs are collected throughout the study period

    Measured: From day 0 to day 517

  5. Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific IgG concentrations for all serotypes included in PCV21

    Ab (antibody) concentrations for each pneumococcal serotype are measured.

    Measured: On day 30 after last vaccination

  6. Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype are determined.

    Measured: On day 30

  7. Number of Children (2-5 years of age [YoA]):with serotype specific IgG concentrations for all serotypes included in PCV21

    Ab concentrations for each pneumococcal serotype are measured.

    Measured: On day 30

  8. Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype are determined.

    Measured: On day 30

Secondary outcomes (6)

  1. Number of Children/adolescents (≥ 2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21

    Serotype specific OPA titers for each pneumococcal serotype are determined.

    Measured: On day 30

  2. Number of Children/adolescents (≥ 2 YoA): with serotype specific IgG concentrations for all serotypes included in PCV21

    Ab concentrations for each pneumococcal serotype are measured.

    Measured: On day 30

  3. Number of participants (all age groups) with serotype specific IgG concentration ≥ 0.35 μg/mL for all serotypes included in PCV21

    Ab concentrations for each pneumococcal serotype are measured.

    Measured: On day 30 after last vaccination

  4. Number of infants (7-11 MoA) and toddlers(12-23 MoA):with serotype specific OPA titers for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype are determined.

    Measured: On day 30 after last vaccination

  5. Percentage of infants (7-11 MoA) and toddlers(12-23 MoA): with serotype specific OPA titers ≥ LLOQ for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype included in the PCV21 formulations are determined. The following threshold values will be considered: ≥ lower limit of quantitation (LLOQ)

    Measured: On day 30 after last vaccination

  6. Number of Children/adolescents (6-17 YoA):with serotype specific IgG concentrations for all serotypes included in PCV21

    Ab concentrations for each pneumococcal serotype are measured.

    Measured: On day 30

Timeline

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

  1. First posted20 Feb 2025
  2. Study start28 Feb 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (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
Model description
Control-Method: Active Controlled
Masking
Single blind
Who is masked
Participant
Enrolment
1,268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838000
Sponsor's protocol ID
PSK00010
Other IDs
U1111-1294-7860, 2024-512271-13
Status last verified
Sep 2025
First submitted
10 Oct 2024
Last updated
6 Oct 2025
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 and 20vPCV in people with Pneumococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 38 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 14 inclusion and 26 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Estonia, Poland, Thailand. 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?

Number of participants reporting immediate adverse events (AEs) (time frame: Within 30 minutes post-vaccination). The study lists 8 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 NCT06838000.

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 6 Oct 2025.

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