CompletedPhase 2

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

Estonia, Philippines420 participantsStarted 2020-12-19

Plain-language summary

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

Who can participate

Age range6 Months – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female subjects of 6 months through \<9 years of age on the day of informed consent/assent.
✓. 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.
✓. 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.
✓. Subjects must provide a baseline blood sample within 10 days prior to the Day 1 vaccination.

Exclusion criteria

✕. Progressive, unstable or uncontrolled clinical conditions.
✕. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
✕. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, ie,
✕. 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.
✕. History of epilepsy or convulsions (excluding febrile convulsions).
✕. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see appendix A).
✕. 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.
✕. Abnormal function of the immune system resulting from:

What they're measuring

Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)

Timeframe: Day 1 through Day 7 and Day 22 through Day 28

Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs

Timeframe: Day 1 through Day 43

Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal

Timeframe: Day 1 through Day 387

Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain

Timeframe: Day 1 (baseline), Day 22, and Day 43

Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain

Timeframe: Day 1 (baseline), Day 22, and Day 43

Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)

Timeframe: Day 1 (baseline), Day 22, and Day 43

Trial details

NCT IDNCT04669691

SponsorSeqirus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-15

Results submitted2023-04-05

View on ClinicalTrials.gov More Influenza, Human trials

Who can participate

Age range6 Months – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female subjects of 6 months through \<9 years of age on the day of informed consent/assent.
✓. 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.
✓. 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.
✓. Subjects must provide a baseline blood sample within 10 days prior to the Day 1 vaccination.

Exclusion criteria

✕. Progressive, unstable or uncontrolled clinical conditions.
✕. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
✕. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, ie,
✕. 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.
✕. History of epilepsy or convulsions (excluding febrile convulsions).
✕. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see appendix A).
✕. 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.
✕. Abnormal function of the immune system resulting from:

What they're measuring

Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)

Timeframe: Day 1 through Day 7 and Day 22 through Day 28

Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs

Timeframe: Day 1 through Day 43

Timeframe: Day 1 through Day 387

Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain

Timeframe: Day 1 (baseline), Day 22, and Day 43

Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain

Timeframe: Day 1 (baseline), Day 22, and Day 43

Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)

Timeframe: Day 1 (baseline), Day 22, and Day 43