Clinical trial NCT06824194: Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pneumococcal Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 2320
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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.

Primary outcomes:
measure: Presence of any immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccination
measure: Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
timeFrame: Through 7 days after each vaccine injection
measure: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
timeFrame: Through 30 days after each vaccine injection
measure: Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
timeFrame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
measure: Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)
timeFrame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research, LLC- Site Number : 8400054
state: Alabama
city: Fullerton
country: United States
facility: Helping Hands Healthcare Group-Fullerton- Site Number : 8400063
state: California
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.- Site Number : 8400055
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research - Los Angeles- Site Number : 8400026
state: California
city: Madera
country: United States
facility: Madera Family Medical Group- Site Number : 8400011
state: California
city: Tarzana
country: United States
facility: Integrated Clinical Research- Site Number : 8400027
state: California
city: Miami
country: United States
facility: ABBA Medical Group- Site Number : 8400064
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials - Blackfoot- Site Number : 8400017
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime- Site Number : 8400022
state: Idaho
city: South Bend
country: United States
facility: South Bend Clinic - Main Campus- Site Number : 8400023
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatric Research- Site Number : 8400014
state: Kentucky
city: Louisville
country: United States
facility: Novak Center for Children's Health- Site Number : 8400073
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research- Site Number : 8400056
state: Kentucky
city: Lafayette
country: United States
facility: MedPharmics - Lafeyette- Site Number : 8400046
state: Louisiana
city: New Orleans
country: United States
facility: NOLA Research Works- Site Number : 8400035
state: Louisiana
city: Silver Spring
country: United States
facility: Virgo Carter Pediatrics- Site Number : 8400001
state: Maryland
city: Minneapolis
country: United States
facility: Clinical Research Institute - Minneapolis- Site Number : 8400002
state: Minnesota
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute- Site Number : 8400019
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute- Site Number : 8400016
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies - Lincoln- Site Number : 8400031
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Childrens Health Research Institute- Site Number : 8400021
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute- Site Number : 8400045
state: Nebraska
city: Henderson
country: United States
facility: PAS Research - Henderson- Site Number : 8400033
state: Nevada
city: East Syracuse
country: United States
facility: Child Health Care Associates - Site Number : 8400005
state: New York
city: New York
country: United States
facility: Advantage Clinical Trials- Site Number : 8400030
state: New York
city: Clyde
country: United States
facility: Haywood Pediatric and Adolescent Medicine- Site Number : 8400051
state: North Carolina
city: Gresham
country: United States
facility: Cyn3rgy Research- Site Number : 8400029
state: Oregon
city: Pittsburgh
country: United States
facility: Pas Research - Pittsburgh- Site Number : 8400050
state: Pennsylvania
city: Charleston
country: United States
facility: Neighbors Pediatrics - Site Number : 8400068
state: South Carolina
city: Simpsonville
country: United States
facility: Tribe Clinical Research at Parkside Pediatrics - Site Number : 8400069
state: South Carolina
city: Edinburg
country: United States
facility: PAS RESEARCH- Site Number : 8400012
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400049
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center- Site Number : 8400024
state: Texas
city: Plano
country: United States
facility: Helios Clinical Research - Plano- Site Number : 8400009
state: Texas
city: Tomball
country: United States
facility: North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400018
state: Texas
city: Kaysville
country: United States
facility: Wee Care Pediatrics - Kaysville- Site Number : 8400028
state: Utah
city: Layton
country: United States
facility: Wee Care Pediatrics-Layton- Site Number : 8400044
state: Utah
city: Orem
country: United States
facility: Utah Valley Pediatrics - Orem- Site Number : 8400053
state: Utah
city: Pleasant View
country: United States
facility: Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032
state: Utah
city: Provo
country: United States
facility: Pediatric Care - Provo- Site Number : 8400041
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics - Roy- Site Number : 8400070
state: Utah
city: Salt Lake City
country: United States
facility: J Lewis Research Inc.- Site Number : 8400058
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics - Syracuse- Site Number : 8400066
state: Utah
city: Richmond
country: United States
facility: National Clinical Research, Inc- Site Number : 8400010
state: Virginia
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400001
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400002
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400003
city: Bayamon
country: Puerto Rico
facility: Investigational Site Number : 6300002
city: Bayamón
country: Puerto Rico
facility: Investigational Site Number : 6300001
Study officials:
References: