Clinical trial NCT06824181: 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
Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-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: 580
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 measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series 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 (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.


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.
* 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.

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
measure: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4
timeFrame: 30 days PD4
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: The Medici Medical Research- Site Number : 8400008
state: Florida
city: Miami
country: United States
facility: Atlantis Clinical Research, LLC- Site Number : 8400009
state: Florida
city: Sioux City
country: United States
facility: Velocity Clinical Research - Sioux City- Site Number : 8400007
state: Iowa
city: Lexington
country: United States
facility: Michael W. Simon, M.D., PSC- Site Number : 8400001
state: Kentucky
city: New Orleans
country: United States
facility: Velocity Clinical Research - New Orleans- Site Number : 8400006
state: Louisiana
city: Syracuse
country: United States
facility: ~SUNY Upstate Medical University- Site Number : 8400015
state: New York
city: Hermitage
country: United States
facility: Kid's Way Pediatrics- Site Number : 8400013
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Associates - Charleston- Site Number : 8400014
state: South Carolina
city: Burleson
country: United States
facility: Helios- Site Number : 8400016
state: Texas
city: Houston
country: United States
facility: Kool Kids Pediatrics- Site Number : 8400012
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch at Galveston- Site Number : 8400005
state: Texas
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Cebu
country: Philippines
facility: Investigational Site Number : 6080001
city: Quezon City
country: Philippines
facility: Investigational Site Number : 6080002
city: Quezon City
country: Philippines
facility: Investigational Site Number : 6080003
Study officials:
References: