A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine

NCT ID: NCT04669691

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-19
• Study Completion Date: 2022-04-15

Brief Summary

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

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Lowest dose, less adjuvant aH5N1 vaccine

Two consecutive intramuscular (IM) administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Low dose, less adjuvant aH5N1 vaccine

Two consecutive IM administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Mid dose, less adjuvant aH5N1 vaccine

Two consecutive IM administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Lowest dose, adjuvanted aH5N1 vaccine

Two consecutive IM administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Low dose, adjuvanted aH5N1 vaccine

Two consecutive IM administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Mid dose, adjuvanted aH5N1 vaccine

Two consecutive IM administrations (Day 1 and Day 22)

Group Type: EXPERIMENTAL

H5N1 antigen combined with MF59 adjuvant

Intervention Type: BIOLOGICAL

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

Interventions

H5N1 antigen combined with MF59 adjuvant

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

Intervention Type: BIOLOGICAL

Other Intervention Names

aH5N1

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seqirus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Program Manager

Role: STUDY_DIRECTOR

Seqirus

Locations

23302- Al Mare Perearstikeskus OÜ

Tallinn, Harju, Estonia

23301- Clinical Research Center

Tartu, Tartu, Estonia

60805 - De La Salle Medical and Health Sciences Institute

Dasmariñas, Manila, Philippines

60804 - University of Perpetual Help Dalta Medical Center

Las Piñas, Manila, Philippines

60802- Philippine General Hospital

Manila, National Capital Region, Philippines

60803- Philippine General Hospital - Pediatrics

Manila, National Capital Region, Philippines

60801- Philippine General Hospital - Pediatrics

Manila, , Philippines

Countries

Estonia; Philippines

References

Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6.

Reference Type: BACKGROUND

PMID: 20819892 (View on PubMed)

Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.

Reference Type: BACKGROUND

PMID: 22777094 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-001898-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V87_30

Identifier Type: -

Identifier Source: org_study_id