Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Hexavalent Vaccine; Vaccines, Combined

Treatments: Biological: Vaxelis™

Study type: Interventional

Funder types: Industry

Identifiers

NCT05289271

V419-016 (Other Identifier)

2021-004053-23 (EudraCT Number)

Details and patient eligibility

About

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™.

Enrollment: 168 patients

Sex: All

Ages: 11 to 13 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Group 1: V, V, V

Experimental group

Description:

Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment will receive a Vaxelis™ booster at \~11 months of age.

Treatment:

Biological: Vaxelis™

Group 2: H, H, V

Experimental group

Description:

Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment will receive a Vaxelis™ booster at \~11 months of age.

Treatment:

Biological: Vaxelis™