Evaluation of a Recombinant Quadrivalent Influenza Vaccine Versus a Marketed Quadrivalent Inactivated Influenza Vaccine in Children 3 to 17.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03460743
• Date of registration: 04/03/2018
• Prospective Registration: Yes
• Primary sponsor: Laboratorios Liomont
• Public title: Evaluation of a Recombinant Quadrivalent Influenza Vaccine Versus a Marketed Quadrivalent Inactivated Influenza Vaccine in Children 3 to 17.
• Scientific title: Evaluation of the Immunogenicity, Relative Efficacy, Safety and Reactogenicity of Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation) Compared With a Marketed Quadrivalent Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years-old.
• Date of first enrolment: March 22, 2018
• Target sample size: 1556
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03460743
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Mexico

Contacts

• Name: Mercedes Macias, MD
• Affiliation: National Institute of Pediatrics

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 3 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza, Human

Intervention(s)

Biological: Study group - quadrivalent recombinant hemagglutinin influenza vaccine

Biological: Control group - quadrivalent inactivated influenza vaccine

Primary Outcome(s)

Seroconversion [Time Frame: To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged]

Secondary ID(s)

LIO-04-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ILS Clinical Research

Epic-CRO

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