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Pneumococcal ImmunizationPhase 3NCT06975878

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

A Phase 3 study testing PCV21 vaccine, Vaxneuvance vaccine and Hexyon vaccine in people with Pneumococcal Immunization and Healthy Volunteers, run by Sanofi at 49 sites in 8 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

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal… Read more about this study

Who is it for?
Ages 42 to 112 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Immunization, Healthy Volunteers
What is being tested?
PCV21 vaccine, Vaxneuvance vaccine and Hexyon vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,092 participants
Where
49 sitesin 8 countries
Study dates
22 May 2025to 25 Aug 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 112 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 42 to 112 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
Show all 20Show fewer
  • Any contraindication to the routine pediatric vaccines being administered in the study
  • History of seizure or significant stable or progressive neurological disorders such as infantile spasms, 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
  • Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally 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.
  • 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 oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
  • Previous vaccination against S. pneumoniae
  • Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus
  • Receipt of more than 1 dose of hepatitis B vaccine
  • 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.

Who cannot join

None listed.

Trial locations and contacts

49 sites in 8 countries.

49 sites in 8 countries

Finland9 sites

  • Investigational Site Number : 2460008

    Espoo, 02230

  • Investigational Site Number : 2460001

    Helsinki, 00100

  • Investigational Site Number : 2460010

    Helsinki, 00290

  • Investigational Site Number : 2460005

    Jarvenpaa, 04400

  • Investigational Site Number : 2460003

    Kokkola, 67100

  • Investigational Site Number : 2460004

    Oulu, 90220

  • Investigational Site Number : 2460002

    Seinäjoki, 60100

  • Investigational Site Number : 2460007

    Tampere, 33100

  • Investigational Site Number : 2460009

    Turku, 20520

Other trials in Finland

Germany8 sites

  • Investigational Site Number : 2760005

    Herxheim, 76863

  • Investigational Site Number : 2760006

    Hürth, 50354

  • Investigational Site Number : 2760014

    Hürth, 50354

  • Investigational Site Number : 2760013

    Krefeld, 47799

  • Investigational Site Number : 2760010

    Mönchengladbach, 41236

  • Investigational Site Number : 2760012

    Mönchengladbach, 41236

  • Investigational Site Number : 2760008

    Schönau am Königssee, 83471

  • Investigational Site Number : 2760003

    Wolfsburg, 38448

Other trials in Germany

Poland8 sites

  • Investigational Site Number : 6160001

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

  • Investigational Site Number : 6160009

    Krakow, Lesser Poland Voivodeship, 30-348

  • Investigational Site Number : 6160005

    Łomianki, Masovian Voivodeship, 05-092

  • Investigational Site Number : 6160002

    Siemianowice Śląskie, Silesian Voivodeship, 41-103

  • Investigational Site Number : 6160007

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Investigational Site Number : 6160003

    Trzebnica, Lower Silesian Voivodeship, 55-100

  • Investigational Site Number : 6160011

    Warsaw, Masovian Voivodeship, 02-647

  • Investigational Site Number : 6160008

    Wroclaw, Lower Silesian Voivodeship, 50-368

Other trials in Poland

Italy7 sites

  • Investigational Site Number : 3800001

    Bari, 70124

  • Investigational Site Number : 3800008

    Foggia, 71122

  • Investigational Site Number : 3800010

    Lecce, 73100

  • Investigational Site Number : 3800007

    Milan, 20122

  • Investigational Site Number : 3800009

    Parma, 43126

  • Investigational Site Number : 3800004

    Rome, Lazio, 00168

  • Investigational Site Number : 3800002

    Rome, Roma, 00161

Other trials in Italy

Belgium6 sites

  • Investigational Site Number : 0560004

    Alken, 3570

  • Investigational Site Number : 0560001

    Bruges, 8000

  • Investigational Site Number : 0560002

    Edegem, 2650

  • Investigational Site Number : 0560005

    Gozée, 6534

  • Investigational Site Number : 0560007

    Leuven, 3000

  • Investigational Site Number : 0560003

    Roeselare, 8800

Other trials in Belgium

Czechia4 sites

  • Investigational Site Number : 2030001

    Jindřichův Hradec, 377 01

  • Investigational Site Number : 2030009

    Krnov, 79401

  • Investigational Site Number : 2030006

    Pilsen, 301 00

  • Investigational Site Number : 2030008

    Prague, 18000

Other trials in Czechia

Greece4 sites

  • Investigational Site Number : 3000001

    Athens, 11527

  • Investigational Site Number : 3000002

    Athens, 12462

  • Investigational Site Number : 3000006

    Ioannina, 45500

  • Investigational Site Number : 3000005

    Thessaloniki, 54642

Other trials in Greece

Estonia3 sites

  • Investigational Site Number : 2330001

    Paide, 72713

  • Investigational Site Number : 2330004

    Tallinn, 10617

  • Investigational Site Number : 2330002

    Tartu, 50106

Other trials in Estonia

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 21-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 PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days).

The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations.

  • There will be 5 (for full-term infants) or 6 (for preterm infants) study visits:
  • Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days.
  • Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 months of age, V06 separated from V05 by 30 days.
Being tested
PCV21 vaccine, Vaxneuvance vaccine, Hexyon vaccine, M-M-RvaxPro vaccine, Varivax vaccine

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

  • Vaxneuvance vaccineBiological

    Also called Vaxneuvance ™

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

  • Hexyon vaccineBiological

    Also called Hexyon®

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

  • M-M-RvaxPro vaccineBiological

    Also called M-M-RVAX-PRO®

    Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous

  • Varivax vaccineBiological

    Also called Varivax®

    Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous

Study groups in NCT06975878
Study groupRoleWhat they receive
Group 1: PCV21ExperimentalParticipants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
Receives: Biological: PCV21 vaccine; Biological: Hexyon vaccine; Biological: M-M-RvaxPro vaccine; Biological: Varivax vaccine
Group 2: 15vPCVActive comparatorParticipants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
Receives: Biological: Vaxneuvance vaccine; Biological: Hexyon vaccine; Biological: M-M-RvaxPro vaccine; Biological: Varivax vaccine

What is being measured

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

  1. Seroresponse rate for PCV21 and 15vPCV serotypes

    Serotype specific IgG concentration ≥ 0.35 µg/mL

    Measured: 30 days post-toddler dose

  2. IgG concentration for PCV21 and 15vPCV serotypes

    Serotype specific IgG Geometric Mean Concentration (GMC)

    Measured: 30 days post-toddler dose

Secondary outcomes (23)

  1. Anti- hepatitis B surface antigen (HBsAg) Ab

    % Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)

    Measured: 30 days post-toddler dose

  2. Anti- polyribosylribitol phosphate (PRP) Ab

    % Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)

    Measured: 30 days post-toddler dose

  3. Anti-poliovirus types (1, 2, and 3) Ab

    % Antibody titers ≥ 1:8

    Measured: 30 days post-toddler dose

  4. Anti-diphtheria Ab concentrations

    % Antibody concentration ≥ 0.1 IU/mL

    Measured: 30 days post-toddler dose

  5. Anti-tetanus Ab concentrations

    % Antibody concentration ≥ 0.1 IU/mL

    Measured: 30 days post-toddler dose

  6. Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))

    Antibody GMC

    Measured: 30 days post-toddler dose

  7. Anti-measles Ab concentrations

    Antibody GMC

    Measured: 30 days post-toddler dose

  8. Anti-mumps Ab concentrations

    Antibody GMC

    Measured: 30 days post-toddler dose

  9. Anti-rubella Ab concentrations

    Antibody GMC

    Measured: 30 days post-toddler dose

  10. Anti-varicella Ab concentrations

    Antibody GMC

    Measured: 30 days post-toddler dose

  11. Anti HBsAg concentrations

    % Antibody concentrations ≥ 10 mIU/mL

    Measured: 30 days post-primary series

  12. Anti-PRP Ab concentrations

    % Antibody concentrations ≥ 0.15 µg/mL

    Measured: 30 days post-primary series

  13. Anti-poliovirus types (1, 2, and 3) Ab titers

    % Antibody titers ≥ 1:8

    Measured: 30 days post-primary series

  14. Anti-diphtheria Ab concentrations

    % Antibody concentrations ≥ 0.1 IU/mL

    Measured: 30 days post-primary series

  15. Anti-tetanus Ab concentrations

    % Antibody concentrations ≥ 0.1 IU/mL

    Measured: 30 days post-primary series

  16. Anti-pertussis Ab concentrations (PT and FHA)

    Antibody GMC

    Measured: 30 days post-primary series

  17. Serotype specific OPA titers for all serotypes included in PCV21

    Antibody Geometric mean titer (GMT)

    Measured: 30 days post-primary series

  18. Serotype specific OPA titers for all serotypes included in PCV21

    Antibody GMT

    Measured: 30 days post-toddler dose

  19. Presence of any immediate adverse events (AEs)

    Number of participants experiencing immediate AEs

    Measured: Within 30 minutes after each vaccine injection

  20. 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

  21. 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

  22. 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 20 months

  23. 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 20 months

Timeline

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

  1. First posted16 May 2025
  2. Study start22 May 2025
  3. Primary completion25 Aug 2027 (estimated)
  4. Study completion25 Aug 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
1,092 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975878
Sponsor's protocol ID
PSK04
Other IDs
2023-507600-32, U1111-1295-6064, 2023
Status last verified
Feb 2026
First submitted
8 May 2025
Last updated
2 Mar 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, Vaxneuvance vaccine and Hexyon vaccine in people with Pneumococcal Immunization and Healthy Volunteers, run by Sanofi at 49 sites in 8 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 20 inclusion and 0 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Finland, Germany, Poland, Italy, Belgium and 3 more countries. 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?

Seroresponse rate for PCV21 and 15vPCV serotypes (time frame: 30 days post-toddler dose). The study lists 2 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 NCT06975878.

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 2 Mar 2026.

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