Clinical trial NCT06975878: Study 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 and Immunogenicity of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pneumococcal Immunization
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 1080
Sex: ALL
Minimum age (years): 42
Maximum age (years): 112
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 PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days).

The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations.

• There will be 5 (for full-term infants) or 6 (for preterm infants) study visits:

* Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days.
* Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 months of age, V06 separated from V05 by 30 days.


Eligibility criteria: Inclusion Criteria:

* Aged 42 to 112 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 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 oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days 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.

Primary outcomes:
measure: Seroresponse rate for PCV21 and 15vPCV serotypes
timeFrame: 30 days post-toddler dose
measure: IgG concentration for PCV21 and 15vPCV serotypes
timeFrame: 30 days post-toddler dose
Secondary outcomes:
measure: Anti- hepatitis B surface antigen (HBsAg) Ab
timeFrame: 30 days post-toddler dose
measure: Anti- polyribosylribitol phosphate (PRP) Ab
timeFrame: 30 days post-toddler dose
measure: Anti-poliovirus types (1, 2, and 3) Ab
timeFrame: 30 days post-toddler dose
measure: Anti-diphtheria Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti-tetanus Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
timeFrame: 30 days post-toddler dose
measure: Anti-measles Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti-mumps Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti-rubella Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti-varicella Ab concentrations
timeFrame: 30 days post-toddler dose
measure: Anti HBsAg concentrations
timeFrame: 30 days post-primary series
measure: Anti-PRP Ab concentrations
timeFrame: 30 days post-primary series
measure: Anti-poliovirus types (1, 2, and 3) Ab titers
timeFrame: 30 days post-primary series
measure: Anti-diphtheria Ab concentrations
timeFrame: 30 days post-primary series
measure: Anti-tetanus Ab concentrations
timeFrame: 30 days post-primary series
measure: Anti-pertussis Ab concentrations (PT and FHA)
timeFrame: 30 days post-primary series
measure: Serotype specific OPA titers for all serotypes included in PCV21
timeFrame: 30 days post-primary series
measure: Serotype specific OPA titers for all serotypes included in PCV21
timeFrame: 30 days post-toddler dose
measure: Presence of any immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccine injection
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 20 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 20 months
Other outcomes:
Locations:
city: Alken
country: Belgium
facility: Investigational Site Number : 0560004
city: Gozée
country: Belgium
facility: Investigational Site Number : 0560005
city: Tallinn
country: Estonia
facility: Investigational Site Number : 2330004
city: Herxheim
country: Germany
facility: Investigational Site Number : 2760005
city: Mönchengladbach
country: Germany
facility: Investigational Site Number : 2760010
city: Trzebnica
country: Poland
facility: Investigational Site Number : 6160003
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160001
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Investigational Site Number : 6160007
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160011
state: Mazowieckie
Study officials:
References: