Pneumococcal ImmunizationPhase 3NCT07348692
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
A Phase 3 study testing PCV21 vaccine and 20vPCV licensed vaccine in people with Pneumococcal Immunization and Healthy Volunteers, run by Sanofi at 25 sites in 4 countries.
Trial summary
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged… 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, Healthy Volunteers
- What is being tested?
- PCV21 vaccine and 20vPCV licensed vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,195 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 20 Jan 2026to 29 May 2028
- Phase
- Phase 3
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
Who cannot join
- 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
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic 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 substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
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- 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.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, 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.
Trial locations and contacts
25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
25 sites in 4 countries
United States14 sites, 14 recruiting
- Recruiting
Michigan Institute of Research- Site Number : 8400004
Allen Park, Michigan, 48101
- Recruiting
Kentucky Pediatric Research- Site Number : 8400036
Bardstown, Kentucky, 40004
- Recruiting
Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
Charleston, South Carolina, 29407
- Recruiting
PAS Research - Children's Care Clinic- Site Number : 8400035
Edinburg, Texas, 78539
- Recruiting
Northwest Arkansas Pediatric Clinic- Site Number : 8400039
Fayetteville, Arkansas, 72703
- Recruiting
Matrix Clinical Research - Huntington Park- Site Number : 8400029
Huntington Park, California, 90255
- Recruiting
Community Clinical Research- Site Number : 8400030
Los Angeles, California, 90008
- Recruiting
Matrix Clinical Research - Los Angeles- Site Number : 8400028
Los Angeles, California, 90057
- Recruiting
Rio Clinical Trials - Canyon View- Site Number : 8400031
Ogden, Utah, 84404
- Recruiting
Pediatric Center - Richmond- Site Number : 8400038
Richmond, Texas, 77469
- Recruiting
Parkside Pediatrics - Simpsonville- Site Number : 8400005
Simpsonville, South Carolina, 29681
- Recruiting
Tribe Clinical Research - Spartanburg- Site Number : 8400026
Spartanburg, South Carolina, 29301
- Recruiting
Nappi Wellness Institute\t- Site Number : 8400037
Syracuse, New York, 13210
- Recruiting
PAS Research - Tampa- Site Number : 8400034
Tampa, Florida, 33613
Thailand5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 7640002
Bangkok, 10400
- Recruiting
Investigational Site Number : 7640004
Chiang Mai, 50180
- Recruiting
Investigational Site Number : 7640003
Hat Yai, 90110
- Recruiting
Investigational Site Number : 7640001
Khon Kaen, 40002
- Recruiting
Investigational Site Number : 7640005
Pathum Wan, 10330
Honduras3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3400001
San Pedro Sula, 21104
- Recruiting
Investigational Site Number : 3400002
Tegucigalpa, 11101
- Recruiting
Investigational Site Number : 3400003
Tegucigalpa, 11101
Puerto Rico3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6300005
Guayama, 00786
- Recruiting
Investigational Site Number : 6300006
San Juan, 00918
- Recruiting
Investigational Site Number : 6300007
Trujillo Alto, 00976
About this study
Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
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, V06 separated from V05 by 30 days
- Conditions
- Pneumococcal Immunization, Healthy Volunteers
- Being tested
- PCV21 vaccine, 20vPCV licensed vaccine
- Keywords
- Pneumococcal Infection, 21 Valent Pneumococcal Vaccine
- Medical subject headings
- Pneumococcal Infections
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
20vPCV licensed vaccineBiological
Also called Prevnar 20™
Pharmaceutical form: Suspension for injection
Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PCV21 | Experimental | Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. Receives: Biological: PCV21 vaccine |
| Group 2: PCV21 | Experimental | Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. Receives: Biological: PCV21 vaccine |
| Group 3: PCV21 | Experimental | Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. Receives: Biological: PCV21 vaccine |
| Group 4: 20vPCV (Cohort A only) | Active comparator | Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. Receives: Biological: 20vPCV licensed vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Measured: 30 days after the third dose of PCV21 vaccine
Secondary outcomes (5)
For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL
Measured: 30 days after the third dose of PCV21 vaccine
For all participants: Presence of any immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Measured: Within 30 minutes after each vaccine injection
For participants in Cohort A (reactogenicity subset): 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
For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Measured: Through 30 days after each vaccine injection
For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Number of participants experiencing SAEs and AESIs
Measured: Throughout the study (through 6 months post-last vaccine injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Jan 2026
- Primary completion7 Jun 2027 (estimated)
- Study completion29 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348692
- Sponsor's protocol ID
- PSK00029
- Other IDs
- PSK00029, U1111-1308-6832
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Oct 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