AzTrials
AzTrials

Sickle Cell DiseasePhase 3NCT07247188

Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease

A Phase 3 study testing PCV21 and 20vPCV in people with Sickle Cell Disease, run by Sanofi at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to measure whether PCV21 vaccine (investigational pneumococcal vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20vPCV (licensed pneumococcal vaccine) when given as a single dose to children aged 2 to 17 years with… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Sickle Cell Disease
What is being tested?
PCV21 and 20vPCV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
7 sitesin 2 countries
Study dates
20 Jan 2026to 7 Jan 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 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • AGE
  • Aged 2 to 17 years on the day of inclusion.
  • TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
  • Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record.
  • SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS
  • A participant is eligible to participate if the participant is not pregnant or breastfeeding and one of the following conditions applies:
Show all 12Show fewer
  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchal 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 study intervention administration until at least 4 weeks after study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before the study intervention.
  • INFORMED CONSENT
  • Assent form has been signed and dated by the participant (based on local regulations), and, if applicable, 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 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 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 thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular (IM) injection.
Show all 27Show 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.
  • For children/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 at least one dose of 20vPCV.
  • For children aged < 6 years: receipt of < 3 doses of pneumococcal conjugate vaccine or any dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23).
  • For children and adolescents aged ≥ 6 years: receipt of PPSV23 < 5 years before study vaccination or last PCV dose < 8 weeks before study vaccination.
  • 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 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.
  • Receipt of an oral or injectable antibiotic therapy for any acute illness 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 study intervention 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 children (2 to 5 YoA) only
  • Being in an emergency setting.
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
  • For children/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

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free number for US & Canada) contact

800-633-1610 ext. Option 6

contact-us@sanofi.com

7 sites in 2 countries

United States5 sites, 5 recruiting

  • Site # 8400006

    Atlanta, Georgia, 30310

    Recruiting

  • Site # 8400002

    Atlanta, Georgia, 30322

    Recruiting

  • Site # 8400004

    Houston, Texas, 77030

    Recruiting

  • Site # 8400001

    New Brunswick, New Jersey, 08901

    Recruiting

  • Site # 8400003

    Omaha, Nebraska, 68114

    Recruiting

Other trials in United States

Dominican Republic2 sites, 2 recruiting

  • Site # 2140001

    Santo Domingo

    Recruiting

  • Site # 2140003

    Santo Domingo

    Recruiting

Other trials in Dominican Republic

About this study

Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease

The purpose of this study is to measure whether PCV21 vaccine (investigational pneumococcal vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20vPCV (licensed pneumococcal vaccine) when given as a single dose to children aged 2 to 17 years with sickle cell disease who had received or not a previous vaccination with pneumococcal conjugate or pneumococcal polysaccharide vaccine.

Read the detailed description

The study duration per participant will be up to 6 months.

Being tested
PCV21, 20vPCV
Keywords
Sickle Cell Disease, Pneumococcal Vaccine, Pneumococcal Conjugate Vaccine
Medical subject headings
Anemia, Sickle Cell

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

    Also called Prevnar 20

    20-valent pneumococcal conjugate vaccine

Study groups in NCT07247188
Study groupRoleWhat they receive
Investigated Vaccine: PCV21ExperimentalParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Receives: Biological: PCV21
Comparator Vaccine: 20vPCVActive comparatorParticipants will receive 1 intramuscular injection of the pneumococcal vaccine
Receives: 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 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 injection of a pneumococcal vaccine

    Measured: Within 30 days post-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 181

  5. Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21

    Ab (antibody) concentrations for each pneumococcal serotype measured by electro-chemiluminescence (ECL) assay

    Measured: On day 30 post-vaccination

Secondary outcomes (3)

  1. Number of participants with serotype-specific IgG concentrations for all serotypes included in PCV21

    Ab concentrations for each pneumococcal serotype are measured by ECL assay

    Measured: Pre-vaccination and at 30 days post-vaccination

  2. Number of participants with serotype specific opsonophagocytic activity (OPA) titers for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype are determined by multiplex opsonophagocytic killing assay (MOPA)

    Measured: On day 30

  3. Number of participants with serotype specific opsonophagocytic activity (OPA) titers for all serotypes included in PCV21

    Serotype specific OPA titers for each pneumococcal serotype are determined by multiplex opsonophagocytic killing assay (MOPA)

    Measured: Pre-vaccination and at 30 days post-vaccination

Timeline

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

  1. First posted25 Nov 2025
  2. Study start20 Jan 2026
  3. Primary completion7 Jan 2027 (estimated)
  4. Study completion7 Jan 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
Model description
Control method: Active-controlled
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07247188
Sponsor's protocol ID
PSK00026
Other IDs
U1111-1319-0153
Status last verified
Apr 2026
First submitted
19 Nov 2025
Last updated
15 Apr 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 and 20vPCV in people with Sickle Cell Disease, run by Sanofi at 7 sites in 2 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 12 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Dominican Republic. 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?

Contact Trial Transparency email recommended (Toll free number for US & Canada) (800-633-1610 ext. Option 6, contact-us@sanofi.com), or a site near the patient. 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 5 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 NCT07247188.

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 15 Apr 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