Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Vaccines, Combined
Hexavalent Vaccine
Eligibility:
All Genders
11-13 years
Phase:
PHASE4
Brief Summary
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 wer...
Eligibility Criteria
Inclusion
- Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05289271
Start Date
March 25 2022
End Date
August 30 2022
Last Update
July 29 2024
Active Locations (13)
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1
Gemeinschaftspraxis Dres. Adelt, Mettlich-Lambrecht und Denneberg ( Site 0053)
Bramsche, Lower Saxony, Germany, 49565
2
Kinderärztliche Gemeinschaftspraxis ( Site 0057)
Wolfsburg, Lower Saxony, Germany, 38448
3
Kinder- und Jugendärzte Hürth-Park ( Site 0054)
Hürth, North Rhine-Westphalia, Germany, 50354
4
Private Practice - Dr. Petri, Kinderarztpraxis ( Site 0056)
Hürth, North Rhine-Westphalia, Germany, 50354