A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: H5N1 antigen combined with MF59 adjuvant
Intervention description: Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pandemic; Influenza; Vaccine; MF59; Adjuvant

Summary:

      This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of
      vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male and female subjects of 6 months through <9 years of age on the day of
             informed consent/assent.

          2. Documented consent provided by the subject's parent(s)/LAR(s) have voluntarily given
             written informed consent/assent after the nature of the study has been explained
             according to local regulatory requirements, prior to study entry.

          3. Subject's parent(s)/LAR(s) able to comprehend and comply with all study procedures,
             and available for all clinic visits and telephone contacts scheduled in the study.

          4. Subjects must provide a baseline blood sample within 10 days prior to the Day 1
             vaccination.

        Exclusion Criteria:

        Each subject must not have:

          1. Progressive, unstable or uncontrolled clinical conditions.

          2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study.

          3. Clinical conditions representing a contraindication to intramuscular vaccination and
             blood draws, ie,

               1. Subjects who have had a fever (body temperature measurement ≥ 38°C) within three
                  days prior to vaccination. The subject may return for vaccination after they have
                  been free of fever for three days.

               2. History of epilepsy or convulsions (excluding febrile convulsions).

               3. A subject who has any medical condition meeting the definition of AESI defined
                  for the purposes of this trial (see appendix A).

               4. Subjects who have received antipyretic medication within the past 24 hours prior
                  to vaccination. The subject may return for vaccination after a period of 24 hours
                  has passed since the administration of an antipyretic.

          4. Abnormal function of the immune system resulting from:

               1. Clinical conditions.

               2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14
                  consecutive days within 90 days prior to informed consent/assent. Topical,
                  inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose
                  in 30 days) of intra-articular corticosteroids are also permitted.

               3. Administration of antineoplastic and immunomodulating agents or radiotherapy from
                  within 90 days prior to informed consent/assent.

          5. Suspicion of pandemic influenza illness within past six months or have ever received
             previous pandemic H5N1 flu vaccination.

          6. Received immunoglobulins or any blood products within 180 days prior to informed
             consent/assent.

          7. Received an investigational or non-registered medicinal within 30 days prior to
             informed consent/assent.

          8. Children of study site staff (this includes research or clinic staff) or children who
             are otherwise related to study site staff or have household members who are study site
             staff. Study site staff are employees with direct or indirect contact with study
             subjects and/or have access to any study documents containing subject information.
             This would include receptionists, persons scheduling appointments or making screening
             calls, regulatory specialists, laboratory technicians, medical assistants, document
             scanners, etc. study personnel as an immediate family or household member.

          9. Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study.

         10. Individuals who received any other vaccines within 14 days (for inactivated vaccines)
             or 28 days (for live vaccines) prior to enrolment in this study or who are planning to
             receive any vaccine prior to day 43. Following day 43 other vaccines may be
             administered, including seasonal flu.