Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
- Conditions
- Pneumococcal Immunization
- Interventions
- Biological: PCV21 vaccineBiological: Prevnar 20 vaccineBiological: M-M-R II vaccine
- Registration Number
- NCT06824194
- Lead Sponsor
- Sanofi
- Brief Summary
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).
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. 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2320
- 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 as assessed by the investigator
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
- 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 substances
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal acceptable representative (LAR(s)), 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 non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
- Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against S. 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: PCV21 PCV21 vaccine Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 M-M-R II vaccine Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 Rotarix Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 RotaTeq Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 Vaxelis vaccine Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 Varivax Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 VAQTA Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 Havrix Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Prevnar 20 vaccine Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV M-M-R II vaccine Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Rotarix Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV RotaTeq Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Vaxelis vaccine Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Varivax Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV VAQTA Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Havrix Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 1: PCV21 Priorix Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA Group 2: 20vPCV Priorix Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA
- Primary Outcome Measures
Name Time Method Presence of any immediate adverse events (AEs) Within 30 minutes after each vaccination Number of participants experiencing solicited and unsolicited immediate AEs
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection Through 7 days after each vaccine injection Number of participants experiencing solicited injection site and systemic reactions
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection Through 30 days after each vaccine injection Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection) Throughout the study (through 6 months post-last vaccine injection), approximately 19 months Number of participants experiencing SAEs
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection) Throughout the study (through 6 months post-last vaccine injection), approximately 19 months Number of participants experiencing AESIs
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (41)
Investigational Site Number : 3400003
🇭🇳Tegucigalpa, Honduras
Investigational Site Number : 6300002
🇵🇷Bayamon, Puerto Rico
Investigational Site Number : 3400001
🇭🇳San Pedro Sula, Honduras
Investigational Site Number : 3400002
🇭🇳Tegucigalpa, Honduras
Helping Hands Healthcare Group-Fullerton- Site Number : 8400063
🇺🇸Fullerton, California, United States
Advanced Investigative Medicine, Inc.- Site Number : 8400055
🇺🇸Hawthorne, California, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400026
🇺🇸Los Angeles, California, United States
Child Health Care Associates - Site Number : 8400005
🇺🇸East Syracuse, New York, United States
Madera Family Medical Group- Site Number : 8400011
🇺🇸Madera, California, United States
Integrated Clinical Research- Site Number : 8400027
🇺🇸Tarzana, California, United States
Clinical Research Prime- Site Number : 8400022
🇺🇸Idaho Falls, Idaho, United States
South Bend Clinic - Main Campus- Site Number : 8400023
🇺🇸South Bend, Indiana, United States
Midwest Children's Health Research Institute- Site Number : 8400045
🇺🇸Lincoln, Nebraska, United States
PAS Research - Henderson- Site Number : 8400033
🇺🇸Henderson, Nevada, United States
Advantage Clinical Trials- Site Number : 8400030
🇺🇸New York, New York, United States
The University of Texas Health Science Center- Site Number : 8400024
🇺🇸Houston, Texas, United States
Pediatric Care - Provo- Site Number : 8400041
🇺🇸Provo, Utah, United States
Wee Care Pediatrics - Syracuse- Site Number : 8400066
🇺🇸Syracuse, Utah, United States
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013
🇺🇸Birmingham, Alabama, United States
Lakeview Clinical Research, LLC- Site Number : 8400054
🇺🇸Guntersville, Alabama, United States
ABBA Medical Group- Site Number : 8400064
🇺🇸Miami, Florida, United States
Kentucky Pediatric Research- Site Number : 8400014
🇺🇸Bardstown, Kentucky, United States
Bluegrass Clinical Research- Site Number : 8400056
🇺🇸Louisville, Kentucky, United States
Midwest Children's Health Research Institute- Site Number : 8400019
🇺🇸Lincoln, Nebraska, United States
Midwest Children's Health Research Institute- Site Number : 8400016
🇺🇸Lincoln, Nebraska, United States
Be Well Clinical Studies - Lincoln- Site Number : 8400031
🇺🇸Lincoln, Nebraska, United States
Midwest Childrens Health Research Institute- Site Number : 8400021
🇺🇸Lincoln, Nebraska, United States
Haywood Pediatric and Adolescent Medicine- Site Number : 8400051
🇺🇸Clyde, North Carolina, United States
Cyn3rgy Research- Site Number : 8400029
🇺🇸Gresham, Oregon, United States
Pas Research - Pittsburgh- Site Number : 8400050
🇺🇸Pittsburgh, Pennsylvania, United States
Neighbors Pediatrics - Site Number : 8400068
🇺🇸Charleston, South Carolina, United States
Tribe Clinical Research at Parkside Pediatrics - Site Number : 8400069
🇺🇸Simpsonville, South Carolina, United States
PAS RESEARCH- Site Number : 8400012
🇺🇸Edinburg, Texas, United States
Helios Clinical Research - Plano- Site Number : 8400009
🇺🇸Plano, Texas, United States
Wee Care Pediatrics - Kaysville- Site Number : 8400028
🇺🇸Kaysville, Utah, United States
Wee Care Pediatrics-Layton- Site Number : 8400044
🇺🇸Layton, Utah, United States
Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032
🇺🇸Pleasant View, Utah, United States
Wee Care Pediatrics - Roy- Site Number : 8400070
🇺🇸Roy, Utah, United States
J Lewis Research Inc.- Site Number : 8400058
🇺🇸Salt Lake City, Utah, United States
National Clinical Research, Inc- Site Number : 8400010
🇺🇸Richmond, Virginia, United States
Investigational Site Number : 6300001
🇵🇷Bayamón, Puerto Rico