Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT ID: NCT06824181
Last Updated: 2025-11-10
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
580 participants
INTERVENTIONAL
2025-02-27
2027-08-26
Brief Summary
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The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). 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 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: 20vPCV-PCV21-PCV21-PCV21
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, PCV21 at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Group 2: 20vPCV-20vPCV-PCV21-PCV21
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, PCV21 at 6 MoA and PCV21 at 12 to 15 MoA
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
20vPCV-20vPCV-20vPCV-PCV21
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and PCV21 at 12 to 15 MoA
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
20vPCV-20vPCV-20vPCV-20vPCV
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2 MoA, 20vPCV at 4 MoA, 20vPCV at 6 MoA and 20vPCV at 12 to 15 MoA
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Interventions
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PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
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
* 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.
* History of seizure or significant stable or progressive neurologic disorders such as 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
* Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legal 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.
* Previous vaccination against Streptococcus pneumoniae
* 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
89 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Kaiser Permanente Los Angeles Medical Center- Site Number : 8400025
Los Angeles, California, United States
The Medici Medical Research- Site Number : 8400008
Hollywood, Florida, United States
Atlantis Clinical Research- Site Number : 8400009
Miami, Florida, United States
Velocity Clinical Research - Sioux City- Site Number : 8400007
Sioux City, Iowa, United States
Private Practice - Dr. Michael W. Simon- Site Number : 8400001
Lexington, Kentucky, United States
Velocity Clinical Research New Orleans- Site Number : 8400006
New Orleans, Louisiana, United States
Finger Lakes Medical Research, PLLC- Site Number : 8400022
Cortland, New York, United States
University of Rochester Medical Center- Site Number : 8400019
Rochester, New York, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400015
Syracuse, New York, United States
Kid's Way Pediatrics- Site Number : 8400013
Hermitage, Pennsylvania, United States
Carolina Family Care - Charleston- Site Number : 8400014
Charleston, South Carolina, United States
Helios Clinical Research - BUR PEDI- Site Number : 8400016
Burleson, Texas, United States
DM Clinical Research - Houston - Jones Road- Site Number : 8400012
Houston, Texas, United States
University of Texas Medical Branch at Galveston- Site Number : 8400005
League City, Texas, United States
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 4840003
León, Guanajuato, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840002
Temixco, Morelos, Mexico
Investigational Site Number : 4840004
Tlaltizapán, Morelos, Mexico
Investigational Site Number : 6080001
Cebu City, , Philippines
Investigational Site Number : 6080002
Quezon City, , Philippines
Investigational Site Number : 6080003
Quezon City, , Philippines
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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PSK00031 Plain Language Results Summary
Other Identifiers
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U1111-1294-7911
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSK00031
Identifier Type: -
Identifier Source: org_study_id