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

Launched by SANOFI · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a new vaccine called PCV21, which is designed to protect infants from infections caused by a bacteria known as Streptococcus pneumoniae. The trial involves healthy infants who are between 42 to 89 days old. To be eligible, infants must have been born full-term and healthy, without any serious medical conditions that could interfere with the study. Unfortunately, infants with certain health issues, like a weakened immune system or a history of seizures, are not eligible to participate.

Participants in the study will receive either the new PCV21 vaccine or a licensed vaccine called 20vPCV at several visits over about 19 months. These visits will occur at ages 2, 4, 6, and 12 to 15 months. Parents can expect regular check-ups to monitor their child's health and any reactions to the vaccine. It's important to know that routine childhood vaccines will still be given according to local health guidelines. Overall, this trial aims to ensure that the new vaccine is safe for infants, adding another layer of protection against serious infections.

Gender

ALL

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 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.