Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Healthy Volunteers; Pneumococcal Immunization

Treatments: Biological: Varivax vaccine; Biological: PCV21 vaccine; Biological: Hexyon vaccine; Biological: M-M-RvaxPro vaccine; Biological: Vaxneuvance vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06975878

U1111-1295-6064 (Other Identifier)

2023-507600-32 (Registry Identifier)

PSK04

Details and patient eligibility

About

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.

Enrollment: 1,080 estimated patients

Sex: All

Ages: 42 to 112 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,080 participants in 2 patient groups

Group 1: PCV21

Experimental group

Description:

Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice

Treatment:

Biological: M-M-RvaxPro vaccine

Biological: Hexyon vaccine

Biological: PCV21 vaccine

Biological: Varivax vaccine

Group 2: 15vPCV

Active Comparator group

Description:

Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice

Treatment:

Biological: Vaxneuvance vaccine

Biological: M-M-RvaxPro vaccine

Biological: Hexyon vaccine

Biological: Varivax vaccine