Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

Official title

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Overview

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). 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, V06 separated from V05 by 30 days

Interventions

• Biological PCV21 vaccine
  Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
• Biological 20vPCV licensed vaccine
  Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Primary outcome measures

• For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC) [Time frame: 30 days after the third dose of PCV21 vaccine]

Secondary outcome measures (5)

• For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL [Time frame: 30 days after the third dose of PCV21 vaccine]
• For all participants: Presence of any immediate adverse events (AEs) [Time frame: Within 30 minutes after each vaccine injection]
• For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection [Time frame: Through 7 days after each vaccine injection]
• For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs [Time frame: Through 30 days after each vaccine injection]
• For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study [Time frame: Throughout the study (through 6 months post-last vaccine injection)]

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

Exclusion criteria

• 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 substances3
• Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally 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.
• Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
• Previous vaccination against Streptococcus 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

United States · 13 centers

• Northwest Arkansas Pediatric Clinic- Site Number : 8400039 — Fayetteville
• Matrix Clinical Research - Huntington Park- Site Number : 8400029 — Huntington Park
• Community Clinical Research- Site Number : 8400030 — Los Angeles
• Matrix Clinical Research - Los Angeles- Site Number : 8400028 — Los Angeles
• PAS Research - Tampa- Site Number : 8400034 — Tampa
• Kentucky Pediatric Research- Site Number : 8400036 — Bardstown
• Michigan Institute of Research- Site Number : 8400004 — Allen Park
• Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 — Charleston
• … and 5 more centers

Honduras · 3 centers

• Investigational Site Number : 3400001 — San Pedro Sula
• Investigational Site Number : 3400002 — Tegucigalpa
• Investigational Site Number : 3400003 — Tegucigalpa

Puerto Rico · 3 centers

• Investigational Site Number : 6300005 — Guayama
• Investigational Site Number : 6300006 — San Juan
• Investigational Site Number : 6300007 — Trujillo Alto

Identifiers

NCT: NCT07348692 · PSK00029 · PSK00029 · U1111-1308-6832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗