Influenza, HumanPhase 2NCT04669691

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

A Phase 2 study testing H5N1 antigen combined with MF59 adjuvant in people with Influenza, Human, run by Seqirus at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 6 months to 8 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: H5N1 antigen combined with MF59 adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 7 sitesin 2 countries
Study dates: 19 Dec 2020to 15 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

Each subject must not have:
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).

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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:
Clinical conditions.
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.
Administration of antineoplastic and immunomodulating agents or radiotherapy from within 90 days prior to informed consent/assent.
Suspicion of pandemic influenza illness within past six months or have ever received previous pandemic H5N1 flu vaccination.
Received immunoglobulins or any blood products within 180 days prior to informed consent/assent.
Received an investigational or non-registered medicinal within 30 days prior to informed consent/assent.
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.
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.
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.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Philippines5 sites

60805 - De La Salle Medical and Health Sciences Institute
Dasmariñas, Manila, 4114
60804 - University of Perpetual Help Dalta Medical Center
Las Piñas, Manila, 1742
60802- Philippine General Hospital
Manila, National Capital Region, 1000
60803- Philippine General Hospital - Pediatrics
Manila, National Capital Region, 1000
60801- Philippine General Hospital - Pediatrics
Manila, 1000

Other trials in Philippines

Estonia2 sites

23302- Al Mare Perearstikeskus OÜ
Tallinn, Harju, 10617
23301- Clinical Research Center
Tartu, Tartu, 50106

Other trials in Estonia

About this study

Official title: A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age

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
Being tested: H5N1 antigen combined with MF59 adjuvant
Keywords: Pandemic, Influenza, Vaccine, MF59, Adjuvant
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

H5N1 antigen combined with MF59 adjuvantBiological
Also called aH5N1
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

Study groups in NCT04669691
Study group	Role	What they receive
Lowest dose, less adjuvant aH5N1 vaccine	Experimental	Two consecutive intramuscular (IM) administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant
Low dose, less adjuvant aH5N1 vaccine	Experimental	Two consecutive IM administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant
Mid dose, less adjuvant aH5N1 vaccine	Experimental	Two consecutive IM administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant
Lowest dose, adjuvanted aH5N1 vaccine	Experimental	Two consecutive IM administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant
Low dose, adjuvanted aH5N1 vaccine	Experimental	Two consecutive IM administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant
Mid dose, adjuvanted aH5N1 vaccine	Experimental	Two consecutive IM administrations (Day 1 and Day 22) Receives: Biological: H5N1 antigen combined with MF59 adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: Day 1 through Day 7 and Day 22 through Day 28
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: 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
Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: 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
GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: 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
GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: 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)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: Day 1 (baseline), Day 22, and Day 43
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Measured: Day 1 (baseline), Day 22, and Day 43

Secondary outcomes (4)

Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination) and Day 202 (6 months after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Measured: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 202/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Measured: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Measured: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1 and Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Measured: Day 1 (baseline) and Day 202

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 202015 Apr 2022

First posted17 Dec 2020
Study start19 Dec 2020
Primary completion15 Apr 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04669691
Sponsor's protocol ID: V87_30
Other IDs: 2016-001898-32, 2016
Status last verified: Feb 2024
First submitted: 30 Nov 2016
Last updated: 13 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\])

Publications

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.
PubMed 20819892
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.
PubMed 22777094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age
ClinicalTrials.gov ID: NCT04669691
Acronym / sponsor ID: V87_30
Conditions: Influenza, Human
Keywords: Pandemic, Influenza, Vaccine, MF59, Adjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: 19 Dec 2020 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 17 Dec 2020 (actual)
Results: Posted 16 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Lowest dose, less adjuvant aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive intramuscular (IM) administrations (Day 1 and Day 22)
Low dose, less adjuvant aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive IM administrations (Day 1 and Day 22)
Mid dose, less adjuvant aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive IM administrations (Day 1 and Day 22)
Lowest dose, adjuvanted aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive IM administrations (Day 1 and Day 22)
Low dose, adjuvanted aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive IM administrations (Day 1 and Day 22)
Mid dose, adjuvanted aH5N1 vaccine	Experimental	Biological: H5N1 antigen combined with MF59 adjuvantTwo consecutive IM administrations (Day 1 and Day 22)

Who may qualify

Ages: 6 months to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (18 listed)

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,
Abnormal function of the immune system resulting from:
Suspicion of pandemic influenza illness within past six months or have ever received previous pandemic H5N1 flu vaccination.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
H5N1 antigen combined with MF59 adjuvantAlso: aH5N1Eligible 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	Biological	Low dose, adjuvanted aH5N1 vaccine, Low dose, less adjuvant aH5N1 vaccine, Lowest dose, adjuvanted aH5N1 vaccine, Lowest dose, less adjuvant aH5N1 vaccine, Mid dose, adjuvanted aH5N1 vaccine, Mid dose, less adjuvant aH5N1 vaccine

Primary outcome

Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Time frame: Day 1 through Day 7 and Day 22 through Day 28
Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Time frame: Day 1 through Day 43
Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
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
Time frame: Day 1 through Day 387
Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain
Time frame: Day 1 (baseline), Day 22, and Day 43
GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain
Time frame: Day 1 (baseline), Day 22, and Day 43
GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Time frame: Day 1 (baseline), Day 22, and Day 43
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Time frame: Day 1 (baseline), Day 22, and Day 43
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort. No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.

4 secondary outcomes

Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
Time frame: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
Time frame: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Time frame: Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Time frame: Day 1 (baseline) and Day 202

Results and safety

Results posted to the registry on 16 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lowest Dose, Less Adjuvant aH5N1 Vaccine	69	69
Low Dose, Less Adjuvant aH5N1 Vaccine	72	71
Mid Dose, Less Adjuvant aH5N1 Vaccine	70	70
Lowest Dose, Adjuvanted aH5N1 Vaccine	70	70
Low Dose, Adjuvanted aH5N1 Vaccine	69	69
Mid Dose, Adjuvanted aH5N1 Vaccine	70	70

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

Time frame: Day 1 through Day 7 and Day 22 through Day 28. Count of participants. Unit: Participants

Measure	Lowest Dose, Less Adjuvant aH5N1 Vaccine n = 69	Low Dose, Less Adjuvant aH5N1 Vaccine n = 72	Mid Dose, Less Adjuvant aH5N1 Vaccine n = 70	Lowest Dose, Adjuvanted aH5N1 Vaccine n = 70	Low Dose, Adjuvanted aH5N1 Vaccine n = 69	Mid Dose, Adjuvanted aH5N1 Vaccine n = 70
Solicited AEs (overall study population)	32	33	32	34	37	31
Solicited Local AEs (overall study population)	19	16	16	21	19	17
Solicited Systemic AEs (overall study population)	21	24	20	24	29	18
Analgesic/antipyretic use (overall study population)	9	7	6	5	5	9
Solicited AEs (6 months to <36 years age cohort)	15	20	18	20	21	15
Solicited Local AEs (6 months to <36 months age cohort)	7	10	6	11	8	4
Solicited Systemic AEs (6 months to <36 months age cohort)	14	15	16	16	18	11
Analgesic/antipyretic use (6 months to <36 months age cohort)	5	4	4	3	3	6

Population analysed: Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data collected, including temperature measurements or use of analgesics/antipyretics. Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.

Primary outcome: Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs

Time frame: Day 1 through Day 43. Count of participants. Unit: Participants

Measure	Lowest Dose, Less Adjuvant aH5N1 Vaccine n = 69	Low Dose, Less Adjuvant aH5N1 Vaccine n = 72	Mid Dose, Less Adjuvant aH5N1 Vaccine n = 70	Lowest Dose, Adjuvanted aH5N1 Vaccine n = 70	Low Dose, Adjuvanted aH5N1 Vaccine n = 69	Mid Dose, Adjuvanted aH5N1 Vaccine n = 70
Unsolicited AEs, Any (overall study population)	18	15	20	10	15	12
Unsolicited AEs, Mild (overall study population)	18	14	20	10	12	9
Unsolicited AEs, Moderate (overall study population)	0	1	0	0	3	2
Unsolicited AEs, Severe (overall study population)	0	0	0	0	0	1
Unsolicited AEs, Related (overall study population)	2	2	2	0	2	1
Unsolicited AEs, Any (6 months to <36 months age cohort)	12	11	13	8	8	7
Unsolicited AEs, Mild (6 months to <36 months age cohort)	12	10	13	8	7	5
Unsolicited AEs, Moderate (6 months to <36 months age cohort)	0	1	0	0	1	2

Population analysed: Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data. Results are presented for the overall study population and for the 6 months to \<36 months and 3 years to \<9 years age cohorts.

Primary outcome: 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

Time frame: Day 1 through Day 387. Count of participants. Unit: Participants

Measure	Low Dose, Less Adjuvant aH5N1 Vaccine n = 72	Mid Dose, Less Adjuvant aH5N1 Vaccine n = 70	Low Dose, Adjuvanted aH5N1 Vaccine n = 69	Mid Dose, Adjuvanted aH5N1 Vaccine n = 70
SAE (overall study population)	1	3	1	3
Related SAE (overall study population)	0	0	0	0
NOCD (overall study population)	1	0	0	0
AESI (overall study population)	0	0	0	0
AE leading to withdrawal (overall study population)	0	0	0	0
Death (overall study population)	1	0	0	0
SAE (6 months to <36 months age cohort)	1	1	1	2
Related SAE (6 months to <36 months age cohort)	0	0	0	0

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

Time frame: Day 1 (baseline), Day 22, and Day 43. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Lowest Dose, Less Adjuvant aH5N1 Vaccine n = 67	Low Dose, Less Adjuvant aH5N1 Vaccine n = 71	Mid Dose, Less Adjuvant aH5N1 Vaccine n = 67	Lowest Dose, Adjuvanted aH5N1 Vaccine n = 66	Low Dose, Adjuvanted aH5N1 Vaccine n = 69	Mid Dose, Adjuvanted aH5N1 Vaccine n = 67
HI GMT Day 1 (overall study population)	5.05 (4.8 to 5.3)	5.00 (4.8 to 5.2)	5.21 (5.0 to 5.4)	5.05 (4.8 to 5.3)	5.00 (4.8 to 5.2)	5.24 (5.0 to 5.5)
HI GMT Day 22 (overall study population)	5.61 (4.9 to 6.4)	6.21 (5.5 to 7.0)	5.98 (5.3 to 6.8)	6.17 (5.4 to 7.0)	6.47 (5.7 to 7.3)	5.78 (5.1 to 6.6)
HI GMT Day 43 (overall study population)	81.10 (58.3 to 112.8)	68.06 (49.4 to 93.8)	86.70 (62.3 to 120.7)	122.43 (87.8 to 170.7)	123.37 (89.1 to 170.8)	123.61 (88.8 to 172.1)
HI GMT Day 1 (6 months to <36 months age cohort)	5.10 (4.9 to 5.3)	5.00 (4.8 to 5.2)	5.42 (5.2 to 5.7)	5.11 (4.9 to 5.3)	5.00 (4.8 to 5.2)	5.00 (4.8 to 5.2)
HI GMT Day 22 (6 months to <36 months age cohort)	5.59 (4.7 to 6.6)	6.14 (5.2 to 7.3)	5.51 (4.6 to 6.6)	6.23 (5.2 to 7.4)	6.55 (5.5 to 7.8)	5.78 (4.8 to 6.9)
HI GMT Day 43 (6 months to <36 months age cohort)	93.22 (56.5 to 153.7)	98.37 (59.6 to 162.4)	102.28 (61.5 to 170.1)	129.72 (78.1 to 215.5)	157.44 (96.7 to 256.3)	120.07 (71.0 to 202.9)
HI GMT Day 1 (3 years to <9 years age cohort)	5.00 (4.6 to 5.4)	5.00 (4.7 to 5.4)	5.00 (4.6 to 5.4)	5.00 (4.6 to 5.4)	5.00 (4.6 to 5.4)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lowest Dose, Less Adjuvant aH5N1 Vaccine	0 of 69 (0%)	37 of 69 (53.6%)	0 of 69
Low Dose, Less Adjuvant aH5N1 Vaccine	1 of 72 (1.4%)	34 of 72 (47.2%)	1 of 72
Mid Dose, Less Adjuvant aH5N1 Vaccine	3 of 70 (4.3%)	40 of 70 (57.1%)	0 of 70
Lowest Dose, Adjuvanted aH5N1 Vaccine	0 of 70 (0%)	39 of 70 (55.7%)	0 of 70
Low Dose, Adjuvanted aH5N1 Vaccine	1 of 69 (1.4%)	37 of 69 (53.6%)	0 of 69
Mid Dose, Adjuvanted aH5N1 Vaccine	3 of 70 (4.3%)	33 of 70 (47.1%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20819892Vesikari 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.
Background: PubMed 22777094Vesikari 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.
Individual participant dataSharing planned: Yes. SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Program Manager study director

Seqirus

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing H5N1 antigen combined with MF59 adjuvant in people with Influenza, Human, run by Seqirus at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Philippines, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs) (time frame: Day 1 through Day 7 and Day 22 through Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669691, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.