Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT ID: NCT06736041
Last Updated: 2025-11-19
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
1630 participants
INTERVENTIONAL
2024-12-18
2027-05-17
Brief Summary
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The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.
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.
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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 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax.
PCV21 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
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
Hexaxim Vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Group 2: 20vPCV
Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax.
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
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
Hexaxim Vaccine
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
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
Hexaxim Vaccine
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
* 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 US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks 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
89 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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Sun City Clinical Research- Site Number : 8400247
Glendale, Arizona, United States
Eclipse Clinical Research- Site Number : 8400029
Tucson, Arizona, United States
Northwest Arkansas Pediatric Clinic- Site Number : 8400030
Fayetteville, Arkansas, United States
Southland Clinical Research Center- Site Number : 8400243
Fountain Valley, California, United States
Century Research Institute- Site Number : 8400065
Huntington Park, California, United States
Matrix Clinical Research - Huntington Park- Site Number : 8400012
Huntington Park, California, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400013
Los Angeles, California, United States
FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063
Ventura, California, United States
Velocity Clinical Research - Washington DC- Site Number : 8400049
Washington D.C., District of Columbia, United States
PAS Research- Site Number : 8400123
Clearwater, Florida, United States
Prohealth Research Center- Site Number : 8400159
Doral, Florida, United States
NurtureGen Research- Site Number : 8400205
Homestead, Florida, United States
Dade Research Center- Site Number : 8400007
Miami, Florida, United States
EMDA Clinical Research- Site Number : 8400237
Miami, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8400089
Miami, Florida, United States
Miami Clinical Research Tower- Site Number : 8400189
Miami, Florida, United States
Bio-Medical Research- Site Number : 8400147
Miami, Florida, United States
High Quality Research- Site Number : 8400245
Miami, Florida, United States
Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032
Miami Lakes, Florida, United States
BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203
Miami Lakes, Florida, United States
Optimal Research Sites- Site Number : 8400232
Orange City, Florida, United States
SEC Clinical Research - Pensacola- Site Number : 8400003
Pensacola, Florida, United States
National Clinical Trials - Tampa- Site Number : 8400229
Tampa, Florida, United States
PAS Research - Tampa- Site Number : 8400002
Tampa, Florida, United States
Medical Research Partners - Ammon- Site Number : 8400239
Ammon, Idaho, United States
Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
Blackfoot, Idaho, United States
Leavitt Women's Healthcare- Site Number : 8400085
Idaho Falls, Idaho, United States
Snake River Research- Site Number : 8400060
Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg- Site Number : 8400250
Rexburg, Idaho, United States
Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
El Dorado, Kansas, United States
Hutchinson Clinic- Site Number : 8400061
Hutchinson, Kansas, United States
Cotton O'Neil Pediatrics- Site Number : 8400009
Topeka, Kansas, United States
KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242
Columbia, Maryland, United States
Michigan Institute of Research- Site Number : 8400207
Allen Park, Michigan, United States
University of Missouri Hospital- Site Number : 8400244
Columbia, Missouri, United States
Vector Clinical Trials- Site Number : 8400249
Las Vegas, Nevada, United States
Prime Global Research- Site Number : 8400246
The Bronx, New York, United States
Monroe Biomedical Research - Monroe- Site Number : 8400225
Monroe, North Carolina, United States
Dayton Clinical Research- Site Number : 8400087
Dayton, Ohio, United States
Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111
Erie, Pennsylvania, United States
Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
Greenville, South Carolina, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400064
North Charleston, South Carolina, United States
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112
Baytown, Texas, United States
South Texas Clinical Research- Site Number : 8400025
Corpus Christi, Texas, United States
FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173
Dallas, Texas, United States
Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072
Fort Worth, Texas, United States
Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
Houston, Texas, United States
Gonzalez Family & Occupational Medicine- Site Number : 8400035
Houston, Texas, United States
La Providence Pediatrics & Family Clinics- Site Number : 8400026
Houston, Texas, United States
Houston Clinical Research Associates- Site Number : 8400018
Houston, Texas, United States
LinQ Research, LLC - Katy- Site Number : 8400258
Katy, Texas, United States
Maximos Ob/Gyn- Site Number : 8400056
League City, Texas, United States
Pediatric Center - Richmond- Site Number : 8400068
Richmond, Texas, United States
Tanner Clinic- Site Number : 8400241
Layton, Utah, United States
Wasatch Pedicatrics- Site Number : 8400153
Murray, Utah, United States
Rio Clinical Trials - Canyon View- Site Number : 8400222
Ogden, Utah, United States
Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236
Richmond, Virginia, United States
Investigational Site Number : 0360001
Westmead, New South Wales, Australia
Investigational Site Number : 0360004
Brisbane, Queensland, Australia
Investigational Site Number : 0360005
Southport, Queensland, Australia
Investigational Site Number : 0360002
Parkville, Victoria, Australia
Investigational Site Number : 0360003
Perth, Western Australia, Australia
Investigational Site Number : 3400001
San Pedro Sula, , Honduras
Investigational Site Number : 3400002
Tegucigalpa, , Honduras
Investigational Site Number : 3400003
Tegucigalpa, , Honduras
Investigational Site Number : 6300004
Caguas, , Puerto Rico
Investigational Site Number : 6300008
Guayama, , Puerto Rico
Investigational Site Number : 6300003
Ponce, , Puerto Rico
Investigational Site Number : 6300002
San Juan, , Puerto Rico
Investigational Site Number : 6300006
San Juan, , Puerto Rico
Investigational Site Number : 6300005
Trujillo Alto, , Puerto Rico
Investigational Site Number : 4100023
Busan, Busan, South Korea
Investigational Site Number : 4100030
Daegu, Daegu, South Korea
Investigational Site Number : 4100024
Daegu, Daegu, South Korea
Investigational Site Number : 4100034
Gwangju, Gwangju, South Korea
Investigational Site Number : 4100020
Ansan-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100002
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100013
Bucheon-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100029
Bucheon-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100014
Hwaseong-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100011
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100001
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100027
Changwon-si, Gyeongsangnam-do, South Korea
Investigational Site Number : 4100010
Yangsan, Gyeongsangnam-do, South Korea
Investigational Site Number : 4100017
Bupyeong-gu, Incheon-gwangyeoksi, South Korea
Investigational Site Number : 4100006
Incheon, Incheon-gwangyeoksi, South Korea
Investigational Site Number : 4100025
Jeonju, Jeollabuk-do, South Korea
Investigational Site Number : 4100019
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100008
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100009
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100015
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100031
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100026
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100022
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100018
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100016
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7640007
Bangkok, , Thailand
Investigational Site Number : 7640005
Bangkok, , Thailand
Investigational Site Number : 7640004
Khon Kaen, , Thailand
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
References
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Pichon S, Ullery GM, Cousin L, Sadarangani M, Ryu JH, Monfredo C, Mari K, Pandey A, Personnic S, Pouzet C, Manson C, Silhadi W, Minutello AM. Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants. Pediatr Infect Dis J. 2025 Oct 1;44(10):995-1008. doi: 10.1097/INF.0000000000004913. Epub 2025 Jul 31.
Related Links
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PSK03 Plain Language Results Summary
Other Identifiers
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U1111-1294-7860
Identifier Type: OTHER
Identifier Source: secondary_id
PSK03
Identifier Type: -
Identifier Source: org_study_id
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