Clinical trial NCT05289271: Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Official title: 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™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccines, Combined
Hexavalent Vaccine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 168
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With a Solicited Systemic AE
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With Unsolicited AEs
timeFrame: Up to 15 days postvaccination
measure: Percentage of Participants With a Serious AE (SAE)
timeFrame: Up to 40 days postvaccination
measure: Percentage of Participants With Diphtheria Toxoid Antibodies ≥0.1 IU/mL
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Tetanus Toxoid Antibodies ≥0.1 IU/mL
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Pertussis Toxoid (PT) Vaccine Response
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Filamentous Hemagglutinin (FHA) Vaccine Response
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Haemophilus Influenzae Type b Polyribosylribitol Phosphate (Hib-PRP) Antibodies ≥1.0 µg/mL
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Antibodies ≥10 mIU/mL
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Poliovirus Serotype 1 Neutralizing Antibodies (Nab) ≥1:8 Dilution
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Poliovirus Serotype 2 Neutralizing Antibodies (Nab) ≥1:8 Dilution
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Poliovirus Serotype 3 Neutralizing Antibodies (Nab) ≥1:8 Dilution
timeFrame: 30 days postvaccination (at ~12 months of age)
Secondary outcomes:
measure: Percentage of Participants With Pertactin (PRN) Vaccine Response
timeFrame: 30 days postvaccination (at ~12 months of age)
measure: Percentage of Participants With Fimbriae 2/3 (FIM 2/3) Vaccine Response
timeFrame: 30 days postvaccination (at ~12 months of age)
Other outcomes:
Locations:
city: Bramsche
country: Germany
facility: Gemeinschaftspraxis Dres. Adelt, Mettlich-Lambrecht und Denneberg ( Site 0053)
state: Niedersachsen
city: Wolfsburg
country: Germany
facility: Kinderärztliche Gemeinschaftspraxis ( Site 0057)
state: Niedersachsen
city: Huerth
country: Germany
facility: Private Practice - Dr. Petri, Kinderarztpraxis ( Site 0056)
state: Nordrhein-Westfalen
city: Hürth
country: Germany
facility: Kinder- und Jugendärzte Hürth-Park ( Site 0054)
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Gemeinschaftspraxis Matthias Donner & Dr. Martin Lüchtrath ( Site 0052)
state: Nordrhein-Westfalen
city: Würselen
country: Germany
facility: Kinderärzte im Recker Park ( Site 0058)
state: Nordrhein-Westfalen
city: Bari
country: Italy
facility: A.O.U.C. Policlinico di Bari-Hygiene ( Site 0105)
state: Puglia
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone ( Site 0102)
state: Sicilia
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0001)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 0011)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario HM Puerta del Sur-Pediatrics ( Site 0005)
state: Madrid, Comunidad De
city: Antequera
country: Spain
facility: Hospital Antequera-Pediatrics Unit ( Site 0004)
state: Malaga
city: Seville
country: Spain
facility: Instituto Hispalense de Pediatria- IHP1 ( Site 0006)
state: Sevilla
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Guerra A, Costantino C, Martinon-Torres F, Westerholt S, Lambeth C, Chen Z, Lumley J, Marcek T, Johnson D, Wilck M. A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016). Hum Vaccin Immunother. 2024 Dec 31;20(1):2310900. doi: 10.1080/21645515.2024.2310900. Epub 2024 Feb 8.