Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT ID: NCT06975878
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1080 participants
INTERVENTIONAL
2025-05-22
2027-08-18
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
* Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff
* No blinding for vaccine group assignment: those preparing and administering the study interventions
Study Groups
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Group 1: PCV21
Participants 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
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hexyon vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-RvaxPro vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Varivax vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Group 2: 15vPCV
Participants 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
Vaxneuvance vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hexyon vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-RvaxPro vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Varivax vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Interventions
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PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Vaxneuvance vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hexyon vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-RvaxPro vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Varivax vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of microbiologically confirmed Streptococcus pneumoniae infection or disease
* 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.
42 Days
112 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 0560004
Alken, , Belgium
Investigational Site Number : 0560001
Bruges, , Belgium
Investigational Site Number : 0560002
Edegem, , Belgium
Investigational Site Number : 0560005
Gozée, , Belgium
Investigational Site Number : 0560007
Leuven, , Belgium
Investigational Site Number : 0560003
Roeselare, , Belgium
Investigational Site Number : 2030001
Jindřichův Hradec, , Czechia
Investigational Site Number : 2030009
Krnov, , Czechia
Investigational Site Number : 2030006
Pilsen, , Czechia
Investigational Site Number : 2030008
Prague, , Czechia
Investigational Site Number : 2330001
Paide, , Estonia
Investigational Site Number : 2330004
Tallinn, , Estonia
Investigational Site Number : 2330002
Tartu, , Estonia
Investigational Site Number : 2460008
Espoo, , Finland
Investigational Site Number : 2460001
Helsinki, , Finland
Investigational Site Number : 2460010
Helsinki, , Finland
Investigational Site Number : 2460005
Järvenpää, , Finland
Investigational Site Number : 2460003
Kokkola, , Finland
Investigational Site Number : 2460004
Oulu, , Finland
Investigational Site Number : 2460002
Seinäjoki, , Finland
Investigational Site Number : 2460007
Tampere, , Finland
Investigational Site Number : 2460009
Turku, , Finland
Investigational Site Number : 2760005
Herxheim, , Germany
Investigational Site Number : 2760006
Hürth, , Germany
Investigational Site Number : 2760014
Hürth, , Germany
Investigational Site Number : 2760013
Krefeld, , Germany
Investigational Site Number : 2760010
Mönchengladbach, , Germany
Investigational Site Number : 2760012
Mönchengladbach, , Germany
Investigational Site Number : 2760008
Schönau am Königssee, , Germany
Investigational Site Number : 2760003
Wolfsburg, , Germany
Investigational Site Number : 3000002
Athens, , Greece
Investigational Site Number : 3000006
Ioannina, , Greece
Investigational Site Number : 3000005
Thessaloniki, , Greece
Investigational Site Number : 3800004
Rome, Roma, Italy
Investigational Site Number : 3800001
Bari, , Italy
Investigational Site Number : 3800008
Foggia, , Italy
Investigational Site Number : 3800010
Lecce, , Italy
Investigational Site Number : 3800007
Milan, , Italy
Investigational Site Number : 3800009
Parma, , Italy
Investigational Site Number : 6160001
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160007
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160009
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160003
Trzebnica, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160008
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160005
Dziekanów Leśny, Masovian Voivodeship, Poland
Investigational Site Number : 6160011
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160002
Siemianowice Śląskie, Silesian Voivodeship, Poland
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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PSK04 Plain Language Results Summary
Other Identifiers
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2023-507600-32
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1295-6064
Identifier Type: OTHER
Identifier Source: secondary_id
PSK04
Identifier Type: -
Identifier Source: org_study_id