Mixed vaccination schedules with pneumococcal vaccines in healthy infants

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

This study is testing a new pneumococcal vaccine for healthy infants to see if it helps their bodies build protection against infections when given after existing vaccines.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 42 Days to 89 Days
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 11 sites (Hollywood, Florida and 10 other locations)
• Trial ID: NCT06824181 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study evaluates the safety and immunogenicity of a new 21-valent pneumococcal conjugate vaccine (PCV21) when administered after one, two, or three doses of an existing 20-valent pneumococcal vaccine in healthy infants aged approximately 2 months. Participants will receive either the PCV21 or the 20-valent vaccine at specified intervals, with a total study duration of about 19 months. The study aims to determine how well the body develops antibodies against pneumococcal infections based on different vaccination schedules.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 42 to 89 days who were born at full term or are medically stable preterm infants.

Not a fit: Patients with known immunodeficiencies, significant neurological disorders, or a history of pneumococcal infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of pneumococcal vaccination in infants, potentially leading to better protection against pneumonia and other related diseases.

How similar studies have performed: Other studies have shown success with similar vaccination approaches, indicating a promising avenue for enhancing pneumococcal immunization.

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.

Where this trial is running

Hollywood, Florida and 10 other locations

• The Medici Medical Research- Site Number : 8400008 — Hollywood, Florida, United States (Recruiting)
• Atlantis Clinical Research, LLC- Site Number : 8400009 — Miami, Florida, United States (Recruiting)
• Velocity Clinical Research - Sioux City- Site Number : 8400007 — Sioux City, Iowa, United States (Recruiting)
• Michael W. Simon, M.D., PSC- Site Number : 8400001 — Lexington, Kentucky, United States (Recruiting)
• Velocity Clinical Research - New Orleans- Site Number : 8400006 — New Orleans, Louisiana, United States (Recruiting)
• ~SUNY Upstate Medical University- Site Number : 8400015 — Syracuse, New York, United States (Recruiting)
• Kid's Way Pediatrics- Site Number : 8400013 — Hermitage, Pennsylvania, United States (Recruiting)
• Helios- Site Number : 8400016 — Burleson, Texas, United States (Recruiting)
• Kool Kids Pediatrics- Site Number : 8400012 — Houston, Texas, United States (Recruiting)
• University of Texas Medical Branch at Galveston- Site Number : 8400005 — League City, Texas, United States (Recruiting)
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana De Santiago, Chile (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Pneumococcal Immunization