Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Dec 13, 2024

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ClinConnect Summary

This clinical trial is studying a new vaccine called PCV21, which aims to help protect babies from infections caused by a type of bacteria known as Streptococcus pneumoniae. The researchers want to find out if this new vaccine is safe and effective at helping babies build up their defenses, called antibodies, against these infections. The trial will involve healthy infants between 2 and 3 months old who will receive either the PCV21 vaccine or the already approved Prevnar 20 vaccine at scheduled visits along with their routine vaccinations.

To participate, babies must be healthy and meet certain criteria, such as being born at full term or being medically stable if born a bit early. Parents can expect their child to be part of the study for about 19 months, which includes several visits for vaccinations and check-ups. It's important to note that some children, such as those with certain medical conditions or previous vaccinations against pneumococcal bacteria, may not be eligible to join the trial. If you think your child might be interested in participating, discussing it with your healthcare provider can help clarify any questions you may have.

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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
• • 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 US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks 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.