Avian InfluenzaPhase 3NCT02839330

A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

A Phase 3 study testing aH5N1c in people with Avian Influenza, run by Seqirus at 26 sites in United States.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Avian Influenza
What is being tested?: aH5N1c
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,196 participants
Where: 26 sitesUnited States
Study dates: 11 Jul 2016to 4 Oct 2017
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.

Who cannot join

Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.
Individuals with known or suspected impairment of the immune system.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

RCR/United Medical Associates, PC
Binghamton, New York, 13901
Radiant Research
Chandler, Arizona, 85224
Medical Research South
Charleston, South Carolina, 29407
Great Lakes Clinical Trials LLC
Chicago, Illinois, 60640
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Aventiv Research
Columbus, Ohio, 43213
Optimal Research, LLC
Huntsville, Alabama, 35802
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Optimal Research, LLC
Melbourne, Florida, 32934
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Optimal Research
Peoria, Illinois, 61614
PMG Research of Raleigh
Raleigh, North Carolina, 60640
Rochester Clinical Research, Inc
Rochester, New York, 14609
Optimal Research, LLC
Rockville, Maryland, 20850
J. Lewis Research Inc.-Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / FirstMed East
Salt Lake City, Utah, 84121
J. Lewis Research, Inc/Foothill Family Clinic South
Salt Lake City, Utah, 84121
Biogenics Research Institute
San Antonio, Texas, 78229
Optimal Research Site
San Diego, California, 92108
California Research Foundation
San Diego, California, 92123
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, 84095
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Clinical Research Consortium Arizona
Tempe, Arizona, 85283
Heartland Research Associates
Wichita, Kansas, 67207
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27609

Other trials in United States

About this study

Official title: A Phase 3 Randomized, Observer-Blind, Multi-center, Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.

Conditions: Avian Influenza
Being tested: aH5N1c, Placebo
Keywords: Influenza, Vaccine, Flu, Avian, Pandemic, H5N1, MF59
Medical subject headings: Influenza in Birds, Influenza, Human

What participants receive

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

aH5N1cBiological
Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
PlaceboBiological
Placebo: Saline injection

Study groups in NCT02839330
Study group	Role	What they receive
Group A	Experimental	aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22) Receives: Biological: aH5N1c
Group B	Experimental	aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22) Receives: Biological: aH5N1c
Group C	Experimental	aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22) Receives: Biological: aH5N1c
Group D	Placebo comparator	Placebo; receive 2 doses (on Day 1 and Day 22) Receives: Biological: Placebo

What is being measured

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

Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Measured: Day 1, Day 43
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to <65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Measured: Day 1, Day 43
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.
Measured: Day 1 to Day 7
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.
Measured: Day 1 to Day 43
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.
Measured: Day 1 to Day 387

Secondary outcomes (7)

Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Estimates of hemagglutination inhibition (HI) GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Measured: Day 1, Day 22, Day 43, and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort are presented. CBER criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.
CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Measured: Day 1, Day 22, Day 43 and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <65 years of age and ≥65 years of age).
Measured: Day 22, and Day 43
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Hemagglutination inhibition (HI) GMTs were assessed over time for the vaccine group and age cohort. Adjusted estimates of GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Measured: Day 1, Day 22, Day 43 and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort. Committee for Medicinal Products for Human Use (CHMP) criterion for subjects aged 18 to <60 years: The percentage of subjects achieving an HI titer ≥1:40 is >70%. CHMP criterion for subjects aged ≥60 years: The percentage of subjects achieving an HI titer ≥1:40 is >60%.
Measured: Day 1, Day 22, Day 43, and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <60 years of age and ≥60 years of age)
Measured: Day 22, and Day 43
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
The GMR of HI titers (Day 22/Day 1, Day 43/Day 1) is presented for the vaccine groups and age cohort. CHMP criterion for subjects aged 18 to <60 years: GMR is >2.5. CHMP criterion for subjects aged ≥60 years: GMR is >2.0.
Measured: Day 1, Day 22, Day 43

Timeline

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

11 Jul 20164 Oct 2017

First posted20 Jul 2016 (estimated)
Study start11 Jul 2016
Primary completion4 Oct 2017
Study completion4 Oct 2017

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 (1)Papers the sponsor has linked to this study.
Other trials for Avian InfluenzaStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02839330
Sponsor's protocol ID: V89_18
Status last verified: Apr 2019
First submitted: 18 Jul 2016
Last updated: 6 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Peterson J, Van Twuijver E, Versage E, Hohenboken M. Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects. Vaccines (Basel). 2022 Mar 23;10(4):497. doi: 10.3390/vaccines10040497.
PubMed 35455245

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?

See locations

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Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Previously Challenged With H10N7 Influenza
Influenza Infection, Infections
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A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
Influenza A
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 3
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
Influenza

All Avian Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Observer-Blind, Multi-center, Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
ClinicalTrials.gov ID: NCT02839330
Acronym / sponsor ID: V89_18
Conditions: Avian Influenza
Keywords: Influenza, Vaccine, Flu, Avian, Pandemic, H5N1, MF59
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,196 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 11 Jul 2016 (actual)
Primary completion: 4 Oct 2017 (actual)
Study completion: 4 Oct 2017 (actual)
First posted: 20 Jul 2016 (estimated)
Results: Posted 4 Apr 2019

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Biological: aH5N1caH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
Group B	Experimental	Biological: aH5N1caH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
Group C	Experimental	Biological: aH5N1caH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
Group D	Placebo comparator	Biological: PlaceboPlacebo; receive 2 doses (on Day 1 and Day 22)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.

Key exclusion criteria (6 listed)

Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.

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
aH5N1cIntramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).	Biological	Group A, Group B, Group C
PlaceboPlacebo: Saline injection	Biological	Group D

Primary outcome

Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Time frame: Day 1, Day 43
Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Time frame: Day 1, Day 43
Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to <65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Time frame: Day 1 to Day 7
Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Time frame: Day 1 to Day 43
Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Time frame: Day 1 to Day 387
Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.

7 secondary outcomes

Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Time frame: Day 1, Day 22, Day 43, and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Time frame: Day 1, Day 22, Day 43 and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Time frame: Day 22, and Day 43
Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Time frame: Day 1, Day 22, Day 43 and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Time frame: Day 1, Day 22, Day 43, and Day 183
Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Time frame: Day 22, and Day 43
Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Time frame: Day 1, Day 22, Day 43

Results and safety

Results posted to the registry on 4 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: aH5N1c Lot #1	804	746
Group B: aH5N1c Lot #2	799	741
Group C: aH5N1c Lot #3	795	747
Group D: Placebo	798	747

Primary outcome: Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot

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

Measure	Group A: aH5N1c Lot #1 n = 761	Group B: aH5N1c Lot #2 n = 747	Group C: aH5N1c Lot #3 n = 741
Day 1	16.1 (15.1 to 17.2)	17.0 (15.9 to 18.2)	17.0 (15.9 to 18.2)
Day 43	128.6 (118.9 to 139.1)	127.4 (117.6 to 138.0)	132.2 (122.1 to 143.1)

Group A: aH5N1c Lot #1 vs Group B: aH5N1c Lot #2: GMT ratio: 1.01 (95% CI 0.90 to 1.13)
Group B: aH5N1c Lot #2 vs Group C: aH5N1c Lot #3: GMT ratio: 0.96 (95% CI 0.86 to 1.08)
Group A: aH5N1c Lot #1 vs Group C: aH5N1c Lot #3: GMT ratio: 0.97 (95% CI 0.87 to 1.09)

Population analysed: Per Protocol Set (PPS) - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample (lot-to-lot consistency) at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.

Primary outcome: Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort

Time frame: Day 1, Day 43. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	aH5N1c n = 2249	Placebo n = 739
Day 1, 18 to <65 years	13.0 (10.7 to 15.6)	15.0 (11.5 to 19.4)
Day 1, ≥65 Years	27.8 (24.9 to 30.9)	24.5 (20.1 to 29.6)
Day 43, 18 to <65 years	95.0 (93.4 to 96.2)	8.5 (5.9 to 12.1)
Day 43, ≥65 Years	85.7 (83.3 to 87.9)	20.8 (16.6 to 25.8)

Population analysed: The PPS consisting of all subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons was used for analysis.

Primary outcome: Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination

Time frame: Day 1 to Day 7. Number. Unit: percentage of subjects

Measure	aH5N1c n = 2395	Placebo n = 796
Any Solicited AE, After Any Vac (D1-D7 excl 30m)	59.7	38.0
Solicited Loc AE, After Any Vac (D1-D7 excl 30m)	50.2	14.7
Solicited Sys AE, After Any Vac (D1-D7 excl 30m)	38.2	32.8
Any Solicited AE, After Vac 1 (D1-D7 excl 30m)	52.4	30.2
Solicited Loc AE, After Vac 1 (D1-D7 excl 30m)	43.2	10.2
Solicited Sys AE, After Vac 1 (D1-D7 excl 30m)	30.7	26.0
Any Solicited AE, After Vac 2 (D1-D7 excl 30m)	41.1	22.3
Solicited Loc AE, After Vac 2 (D1-D7 excl 30m)	33.9	7.4

Population analysed: The overall safety set consisting of all subjects who received a study vaccination who underwent any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics was used for analysis.

Primary outcome: Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination

Time frame: Day 1 to Day 43. Number. Unit: percentage of subjects

Measure	aH5N1c n = 2395	Placebo n = 796
Unsolicited AEs, V1 or V2	23.4	22.2
Possibly/probably related unsolicited AE, V1 or V2	7.0	6.2
Unsolicited AE, V1	15.3	13.2
Possibly/probably related unsolicited AE, V1	4.8	3.8
Unsolicited AE, V2	12.2	11.9
Possibly/probably related unsolicited AE, V2	2.8	2.8

Population analysed: The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 387. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aH5N1c	161 of 2,395 (6.7%)	91 of 2,395 (3.8%)	11 of 2,395
Placebo	74 of 796 (9.3%)	44 of 796 (5.5%)	1 of 796

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35455245Peterson J, Van Twuijver E, Versage E, Hohenboken M. Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects. Vaccines (Basel). 2022 Mar 23;10(4):497. doi: 10.3390/vaccines10040497.
Individual participant dataSharing planned: Undecided

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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 Director study director

Seqirus

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aH5N1c in people with Avian Influenza, run by Seqirus at 26 sites in United States.

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 1 inclusion and 6 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 4 Apr 2019). 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?

Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot (time frame: Day 1, Day 43). The study lists 5 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 NCT02839330, which also lists 1 linked publication.

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 6 Dec 2024.