Status:
COMPLETED
Evaluation of a Recombinant Quadrivalent Influenza Vaccine Versus a Marketed Quadrivalent Inactivated Influenza Vaccine in Children 3 to 17.
Lead Sponsor:
Laboratorios Liomont
Collaborating Sponsors:
EPIC Research CRO
ILS Clinical Research
Conditions:
Influenza, Human
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a ...
Detailed Description
Abbreviated title Evaluation of immunogenicity, relative efficacy, safety and reactogenicity of Flublok Quadrivalent® in healthy children and adolescents aged 3 to17 years. Sponsor Product Identifier...
Eligibility Criteria
Inclusion
- Male or female age 3 to 17 years.
- History of two previous influenza immunizations at any time, or influenza infection during the previous year.
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to prevent pregnancy and usage of an effective contraception, or having practiced sexual abstinence for at least 28 day prior to the first study vaccine administration. Female subjects of child-bearing potential must be tested for pregnancy within 24 hours prior to vaccine administration.
- In good general health, healthy or medically stable, as determined by the medical history, physical examination and the Investigator's judgment.
- Parent(s) or legal representative of each potential subject must comprehend the study requirements, sign the informed consent before any procedure, and agree to comply with planned study procedures and visits. Provide written consent prior to enrollment and initiation of any study procedure.
- Pediatric consent will be attained as per the Research Ethics Committee's determination when subject is aged 8 or older.
Exclusion
- Known allergy to eggs (anaphylaxis, angioedema, respiratory distress), severe allergy (e.g. anaphylaxis) to other components of the vaccine or contraindications to receive the comparator IIV4.
- Use of systemic steroids at doses of 2mg/kg/day for more than 10 days of prednisone or its equivalent.
- (The use of nasal or topical steroids will be allowed).
- Active neoplastic disease or a history of any malignancy.
- History of receiving the influenza vaccine within the previous 6 months.
- Plan to receive another influenza vaccine, during the study term.
- History of receiving immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- Acute or chronic medical condition that, in the opinion of the Investigator, would render immunization unsafe or would interfere with the evaluation of efficacy or the immune response to the vaccine.
- An acute illness, including a body temperature greater than 37.7°C, within 3 days prior to immunization.
- Receive an experimental vaccine or medication within 1 month prior to enrollment in this study, or the expectation to receive an experimental vaccine, medication, or blood product during the study period.
- Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical assistance (note: history of febrile seizure is not considered an exclusion criterion).
- History of Guillain-Barré syndrome within 6 weeks after the application a previous influenza vaccine.
- Concurrent participation in another clinical trial (active or follow-up phase).
- Any other condition or situation that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2019
Estimated Enrollment :
1556 Patients enrolled
Trial Details
Trial ID
NCT03460743
Start Date
March 22 2018
End Date
October 22 2019
Last Update
November 13 2019
Active Locations (11)
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1
Clinical Research Institute Saltillo
Saltillo, Coahuila, Mexico, 25020
2
Centro de Investigacion Clinica del Pacifico
Acapulco de Juárez, Guerrero, Mexico, 39670
3
AMIC Pachuca
Pachuca, Hidalgo, Mexico, 42070
4
Instituto Jalisciencie de Metabolismo
Guadalajara, Jalisco, Mexico, 44670