A/Vietnam/H5N1 Influenza VirusPhase 2NCT02680002

Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

A Phase 2 study testing 7.5 mcg H5N1 (stored as monobulk), 15 mcg H5N1 (stored as monobulk) and 90 mcg H5N1 (stored as monobulk) in people with A/Vietnam/H5N1 Influenza Virus, run by Biomedical Advanced Research and Development Authority at 6 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

The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: A/Vietnam/H5N1 Influenza Virus
What is being tested?: 7.5 mcg H5N1 (stored as monobulk), 15 mcg H5N1 (stored as monobulk) and 90 mcg H5N1 (stored as monobulk)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 422 participants
Where: 6 sitesUnited States
Study dates: Mar 2016to 31 Mar 2017
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 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or nonpregnant female
Provide written informed consent prior to study-related procedures
Stable health status
Access to consistent and reliable means of telephone contact
Able to understand and comply with planned study procedures
Agree to stay in contact with site, and no plans to move from study area for study duration

Who cannot join

Allergic to eggs, other vaccine components, or squalene-based adjuvants
Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
Have an active neoplastic disease or history of hematologic malignancy
Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Radiant Research, Inc.
Atlanta, Georgia, 30328
Clinical Research Advantage, Inc./Ridge Family Practice
Council Bluffs, Iowa, 51503
Radiant Research, Inc.
Edina, Minnesota, 55435
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, 66219
Central Kentucky Researcch Associates, Inc.
Lexington, Kentucky, 40509
Rochester Clinical Research, Inc.
Rochester, New York, 14609

Other trials in United States

About this study

Official title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant

Read the detailed description

This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored >10 years) and adjuvant (ie, stored >5 years).

Conditions: A/Vietnam/H5N1 Influenza Virus
Being tested: 7.5 mcg H5N1 (stored as monobulk), 15 mcg H5N1 (stored as monobulk), 90 mcg H5N1 (stored as monobulk), 90 mcg H5N1 (stored in vials), MF59

What participants receive

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

7.5 mcg H5N1 (stored as monobulk)Biological
15 mcg H5N1 (stored as monobulk)Biological
90 mcg H5N1 (stored as monobulk)Biological
90 mcg H5N1 (stored in vials)Biological
MF59Other
MF59 (stored as monobulk)Other

Study groups in NCT02680002
Study group	Role	What they receive
7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)	Experimental	Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated Receives: Biological: 7.5 mcg H5N1 (stored as monobulk); Other: MF59 (stored as monobulk)
15 mcg H5N1 (monobulk) Plus MF59 (monobulk)	Experimental	Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant Receives: Biological: 15 mcg H5N1 (stored as monobulk); Other: MF59 (stored as monobulk)
7.5 mcg H5N1 (monobulk) Plus MF59 (vials)	Experimental	Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant Receives: Biological: 7.5 mcg H5N1 (stored as monobulk); Other: MF59
15 mcg H5N1 (monobulk) Plus MF59 (vials)	Experimental	Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant Receives: Biological: 15 mcg H5N1 (stored as monobulk); Other: MF59
90 mcg H5N1 (monobulk) without MF59	Experimental	Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59 Receives: Biological: 90 mcg H5N1 (stored as monobulk)
90 mcg H5N1 (vials) without MF59	Experimental	Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59 Receives: Biological: 90 mcg H5N1 (stored in vials)

What is being measured

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

Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Measured: Days 0 to 7
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
Measured: Days 21 to 28
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Measured: Days 0 to 7
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Measured: Days 21 to 28
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Measured: Days 0 to 7
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2
Measured: Days 21 to 28
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Measured: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)

Secondary outcomes (10)

Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal
Measured: First vaccination through 13 months
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.
Measured: First vaccination through approximately 13 months after first vaccination
Number of Participants With Unsolicited Adverse Events (AE)
Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
Measured: Day 0 (Visit 1) through Day 201 (Visit 8)
Frequency of Unsolicited Adverse Events (AE)
Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days)
Measured: 21 days following each vaccination (Days 0-21, >21 Days)
Occurrence of Clinical Safety Laboratory AEs
Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
Measured: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
Measured: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
Measured: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
Measured: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Defined as proportion of subjects achieving either a prevaccination HAI titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Measured: Days 21, 28, 42, and 201
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Defined as proportion of subjects achieving either a prevaccination MN titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Measured: Days 21, 28, 42, and 201

Timeline

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

Mar 201631 Mar 2017

First posted11 Feb 2016 (estimated)
Study startMar 2016
Primary completion13 May 2016
Study completion31 Mar 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 A/Vietnam/H5N1 Influenza VirusStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02680002
Sponsor's protocol ID: BARDA CSN 15-0001
Status last verified: Apr 2019
First submitted: 26 Jan 2016
Last updated: 31 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: The study results will be posted on publicly available clinical trial registers.

Publications

Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team; Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.
PubMed 30553570

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant
ClinicalTrials.gov ID: NCT02680002
Acronym / sponsor ID: BARDA CSN 15-0001
Conditions: A/Vietnam/H5N1 Influenza Virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: Biomedical Advanced Research and Development AuthorityUS federal agency
Collaborators: PPD Development, LP
Study start: Mar 2016
Primary completion: 13 May 2016 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 11 Feb 2016 (estimated)
Results: Posted 31 Aug 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)	Experimental	Biological: 7.5 mcg H5N1 (stored as monobulk), Other: MF59 (stored as monobulk)Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated
15 mcg H5N1 (monobulk) Plus MF59 (monobulk)	Experimental	Biological: 15 mcg H5N1 (stored as monobulk), Other: MF59 (stored as monobulk)Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant
7.5 mcg H5N1 (monobulk) Plus MF59 (vials)	Experimental	Biological: 7.5 mcg H5N1 (stored as monobulk), Other: MF59Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
15 mcg H5N1 (monobulk) Plus MF59 (vials)	Experimental	Biological: 15 mcg H5N1 (stored as monobulk), Other: MF59Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
90 mcg H5N1 (monobulk) without MF59	Experimental	Biological: 90 mcg H5N1 (stored as monobulk)Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
90 mcg H5N1 (vials) without MF59	Experimental	Biological: 90 mcg H5N1 (stored in vials)Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male or nonpregnant female
Provide written informed consent prior to study-related procedures
Stable health status
Access to consistent and reliable means of telephone contact
Able to understand and comply with planned study procedures

Key exclusion criteria (8 listed)

Allergic to eggs, other vaccine components, or squalene-based adjuvants
Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
Have an active neoplastic disease or history of hematologic malignancy

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
7.5 mcg H5N1 (stored as monobulk)	Biological	7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk), 7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
15 mcg H5N1 (stored as monobulk)	Biological	15 mcg H5N1 (monobulk) Plus MF59 (monobulk), 15 mcg H5N1 (monobulk) Plus MF59 (vials)
90 mcg H5N1 (stored as monobulk)	Biological	90 mcg H5N1 (monobulk) without MF59
90 mcg H5N1 (stored in vials)	Biological	90 mcg H5N1 (vials) without MF59
MF59	Other	15 mcg H5N1 (monobulk) Plus MF59 (vials), 7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
MF59 (stored as monobulk)	Other	15 mcg H5N1 (monobulk) Plus MF59 (monobulk), 7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)

Primary outcome

Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 0 to 7
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 21 to 28
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 0 to 7
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 21 to 28
Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 0 to 7
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Time frame: Days 21 to 28
Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Time frame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group

10 secondary outcomes

Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Time frame: First vaccination through 13 months
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Time frame: First vaccination through approximately 13 months after first vaccination
Number of Participants With Unsolicited Adverse Events (AE)
Time frame: Day 0 (Visit 1) through Day 201 (Visit 8)
Frequency of Unsolicited Adverse Events (AE)
Time frame: 21 days following each vaccination (Days 0-21, >21 Days)
Occurrence of Clinical Safety Laboratory AEs
Time frame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Time frame: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Time frame: Days 21, 28, 42, and 201
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Time frame: Days 21, 28, 42, and 201

Results and safety

Results posted to the registry on 31 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)	71	58
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)	70	66
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)	70	60
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)	71	67
90 mcg H5N1 (Monobulk) Without MF59	70	59
90 mcg H5N1 (Vials) Without MF59	70	61

Primary outcome: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

Time frame: Days 0 to 7. Number. Unit: occurrences

Measure	7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 70	15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 70	7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 70	15 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 71	90 mcg H5N1 (Monobulk) Without MF59 n = 70	90 mcg H5N1 (Vials) Without MF59 n = 68
Total number solicited local AEs (Adverse Events)	34	41	34	34	28	33
Total no. Mild solicited AEs	31	37	30	29	23	29
Total no. Moderate solicited AEs	3	4	4	3	5	4
Total no. Severe solicited AEs	0	0	0	2	0	0

Population analysed: Participants who received Dose 1 (Day 0), analyzed up to Day 7.

Primary outcome: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

Time frame: Days 21 to 28. Number. Unit: occurrences

Measure	7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 63	15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 68	7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 65	15 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 69	90 mcg H5N1 (Monobulk) Without MF59 n = 65	90 mcg H5N1 (Vials) Without MF59 n = 63
Total number solicited local AEs (Adverse Events)	26	24	23	24	18	23
Total no. Mild solicited AEs	26	22	23	23	17	21
Total no. Moderate solicited AEs	0	2	0	1	1	2
Total no. Severe solicited AEs	0	0	0	0	0	0

Population analysed: Participants who received Dose 2 (Day 21), analyzed up to Day 28.

Primary outcome: Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

Time frame: Days 0 to 7. Count of participants. Unit: Participants

Measure	7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 70	15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 70	7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 70	15 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 71	90 mcg H5N1 (Monobulk) Without MF59 n = 70	90 mcg H5N1 (Vials) Without MF59 n = 68
Total number solicited local AEs (Adverse Events)	25	31	27	27	22	25
Total no. Mild solicited local AEs	23	28	24	24	18	21
Total no. Moderate solicited local AEs	2	3	3	2	4	4
Total no. Severe solicited local AEs	0	0	0	1	0	0

Population analysed: Participants who received Dose 1 (Day 0), analyzed up to Day 7.

Primary outcome: Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

Time frame: Days 21 to 28. Count of participants. Unit: Participants

Measure	7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 63	15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) n = 68	7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 65	15 mcg H5N1 (Monobulk) Plus MF59 (Vials) n = 69	90 mcg H5N1 (Monobulk) Without MF59 n = 65	90 mcg H5N1 (Vials) Without MF59 n = 63
Total number solicited local AEs (Adverse Events)	20	20	17	21	17	21
Total no. Mild solicited local AEs	20	19	17	20	16	19
Total no. Moderate solicited local AEs	0	1	0	1	1	2
Total no. Severe solicited local AEs	0	0	0	0	0	0

Population analysed: Participants who received Dose 2 (Day 21), analyzed up to Day 28.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)	0 of 70 (0%)	44 of 70 (62.9%)	0 of 70
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)	1 of 71 (1.4%)	49 of 71 (69%)	0 of 71
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)	3 of 70 (4.3%)	47 of 70 (67.1%)	0 of 70
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)	0 of 71 (0%)	57 of 71 (80.3%)	0 of 71
90 mcg H5N1 (Monobulk) Without MF59	1 of 70 (1.4%)	48 of 70 (68.6%)	0 of 70
90 mcg H5N1 (Vials) Without MF59	2 of 69 (2.9%)	47 of 69 (68.1%)	0 of 69

Limitations and caveats (from the sponsor): Protocol implied Clinical Study Report (CSR) would include Day 386 (end-of-study) data. Following start of study it was decided CSR would include data up to and including Day 201. CSR addendum will include data from Day 201-Day 386.

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30553570Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team; Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.
Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. The study results will be posted on publicly available clinical trial registers.

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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 31 Aug 2020). 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?

Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. (time frame: Days 0 to 7). 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 NCT02680002, 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 31 Aug 2020.