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

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Pneumococcal Immunization

Treatments: Biological: Varivax; Biological: M-M-R II vaccine; Biological: Rotarix; Biological: PCV21 vaccine; Biological: Priorix; Biological: RotaTeq; Biological: VAQTA; Biological: Prevnar 20 vaccine; Biological: Havrix; Biological: Vaxelis vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06824194

PSK05

U1111-1295-5983 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,320 estimated patients

Sex: All

Ages: 42 to 89 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2,320 participants in 2 patient groups

Group 1: PCV21

Experimental group

Description:

Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA

Treatment:

Biological: Vaxelis vaccine

Biological: Havrix

Biological: VAQTA

Biological: Priorix

Biological: RotaTeq

Biological: PCV21 vaccine

Biological: Rotarix

Biological: Varivax

Biological: M-M-R II vaccine

Group 2: 20vPCV

Active Comparator group

Description:

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA

Treatment:

Biological: Vaxelis vaccine

Biological: Havrix

Biological: VAQTA

Biological: Priorix

Biological: RotaTeq

Biological: Prevnar 20 vaccine

Biological: Rotarix

Biological: Varivax

Biological: M-M-R II vaccine