A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™

V419-016

The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at \~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.

2022-03-25

2022-08-30

2022-08-30

Completed

Early phase I

168

Inclusion Criteria: * Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age Exclusion Criteria: * Has known or suspected impaired immunological function * Has known or history of functional or anatomic asplenia. * Has a known hypersensitivity to any component of the study vaccine. * Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system * Has a bleeding disorder contraindicating intramuscular vaccination * Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection * Was born to a mother with a known history of hepatitis B infection * Had a recent febrile illness (defined as rectal temperature ≥38.1°C \[≥100.5°F\] or axillary temperature ≥37.8°C \[≥100.0°F\]) occurring at or within 72 hours prior to receipt of study vaccine * Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine * Has an uncontrolled neurologic disorder or uncontrolled epilepsy. * Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine * Has received or is expected to receive an immunosuppressive agent * Meets corticosteroid use criteria * Has received any licensed, non-live vaccine within 14 days of study vaccine * Has received any license live vaccine within 30 days of study vaccine * Has received a blood transfusion or blood product within 6 months of study vaccine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 168, 'type': 'ACTUAL'}}

2023-09-06