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™

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 sites168 target enrollmentDecember 3, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Enrollment: 168
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

December 3, 2021

End Date

January 17, 2023

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

•1\. Is healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
•2\. Has received a 2\-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age (based on a review of medical history), respectively.
•3\. Is male or female, from approximately 11 months to 13 months of age (\=327 days to \=396 days) inclusive, at the time of obtaining the informed consent.
•4\. A legally acceptable representative has provided documented informed consent for the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 160
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Has a known or suspected impairment of immunological function.
•2\. Has known or history of functional or anatomic asplenia.
•3\. Has a known hypersensitivity to any component of the study vaccine.
•4\. Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system.
•5\. Has a bleeding disorder contraindicating intramuscular vaccination.
•6\. Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection.
•7\. Was born to a mother with a known history of hepatitis B infection.
•8\. \*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.
•9\. Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
•10\. Has an uncontrolled neurologic disorder or uncontrolled epilepsy.