InfluenzaPhase 1FLU-ANCT00819013

Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

A Phase 1 study testing Influenza A Vaccine: ACAM FLU-A in people with Influenza, run by Sanofi at 3 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

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza A Vaccine: ACAM FLU-A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 3 sitesUnited States
Study dates: Jul 2007to Feb 2009
Phase: Phase 1
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adult males or females 18 - 40 years of age in good general health

Who cannot join

Known allergies or severe reactions to any of the vaccine components including those to adjuvants
History of severe allergic reactions, including angioedema;
History of asthma or recurrent wheezing; (current or within past 2 years);
History of neurological symptoms or signs following administration of any vaccine;

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
Northwest Kinetics
Tacoma, Washington, 98418

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults

Subjects will be randomized according to a randomization scheme.

Read the detailed description

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Conditions: Influenza
Being tested: Influenza A Vaccine: ACAM FLU-A, Saline placebo
Medical subject headings: Influenza, Human

What participants receive

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

Influenza A Vaccine: ACAM FLU-ABiological
Also called ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Influenza A Vaccine: ACAM FLU-ABiological
Also called ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Influenza A Vaccine: ACAM FLU-ABiological
Also called ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Saline placeboBiological
Also called USP Saline
0.5 mL, Intramuscular

Study groups in NCT00819013
Study group	Role	What they receive
Study Group 1	Experimental	ACAM-FLU-A low dose + Adjuvant 1 Receives: Biological: Influenza A Vaccine: ACAM FLU-A
Study Group 2	Experimental	ACAM-FLU-A low dose + Adjuvant 2 Receives: Biological: Influenza A Vaccine: ACAM FLU-A
Study Group 3	Experimental	ACAM-FLU-A low dose Receives: Biological: Influenza A Vaccine: ACAM FLU-A
Study Group 4	Placebo comparator	Saline placebo Receives: Biological: Saline placebo

What is being measured

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

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Measured: Day 0 through Day 60 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Measured: Day 0 through Day 7 post-vaccination
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Measured: Day 0 through Day 60 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Measured: Day 15 through Month 10 Post-vaccination 1
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).
A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Measured: Day 15 through Month 10 Post-vaccination 1

Secondary outcomes (6)

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Measured: Month 4 through Month 10 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Measured: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Measured: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Measured: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Measured: Day 0 and Day 15 through Month 10 post-vaccination 1
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.
Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Measured: Day 0 and Day 15 through Month 10 Post-vaccination 1

Timeline

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

Jul 2007Feb 2009

First posted8 Jan 2009 (estimated)
Study startJul 2007
Primary completionJan 2009
Study completionFeb 2009

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 InfluenzaStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00819013
Sponsor's protocol ID: H-261-001
Acronym: FLU-A
Status last verified: Jan 2012
First submitted: 10 Oct 2008
Last updated: 19 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.
PubMed 23527091

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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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults
ClinicalTrials.gov ID: NCT00819013
Acronym / sponsor ID: FLU-A / H-261-001
Conditions: Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jan 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 8 Jan 2009 (estimated)
Results: Posted 16 Jan 2012

Clinical summary

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

Subjects will be randomized according to a randomization scheme.

Detailed description

Study design

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

Arm	Type	Receives
Study Group 1	Experimental	Biological: Influenza A Vaccine: ACAM FLU-AACAM-FLU-A low dose + Adjuvant 1
Study Group 2	Experimental	Biological: Influenza A Vaccine: ACAM FLU-AACAM-FLU-A low dose + Adjuvant 2
Study Group 3	Experimental	Biological: Influenza A Vaccine: ACAM FLU-AACAM-FLU-A low dose
Study Group 4	Placebo comparator	Biological: Saline placeboSaline placebo

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Adult males or females 18 - 40 years of age in good general health

Key exclusion criteria (4 listed)

Known allergies or severe reactions to any of the vaccine components including those to adjuvants
History of severe allergic reactions, including angioedema;
History of asthma or recurrent wheezing; (current or within past 2 years);
History of neurological symptoms or signs following administration of any vaccine;

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
Influenza A Vaccine: ACAM FLU-AAlso: ACAM FLU-A0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular	Biological	Study Group 1
Influenza A Vaccine: ACAM FLU-AAlso: ACAM FLU-A0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular	Biological	Study Group 2
Influenza A Vaccine: ACAM FLU-AAlso: ACAM FLU-A0.5 mL ACAM FLU-A low dose, Intramuscular	Biological	Study Group 3
Saline placeboAlso: USP Saline0.5 mL, Intramuscular	Biological	Study Group 4

Primary outcome

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 through Day 7 post-vaccination
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Time frame: Day 15 through Month 10 Post-vaccination 1
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time frame: Day 15 through Month 10 Post-vaccination 1
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

6 secondary outcomes

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Month 4 through Month 10 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 and Day 15 through Month 10 post-vaccination 1
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 and Day 15 through Month 10 Post-vaccination 1

Results and safety

Results posted to the registry on 16 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACAM-FLU-A Adjuvanted With Alhydrogel	22	19
ACAM-FLU-A Adjuvanted With Stimulon® QS-21	23	22
ACAM FLU A Without Adjuvant	21	16
Saline Placebo	21	17

Primary outcome: Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.

Time frame: Day 0 through Day 60 post-vaccination. Number. Unit: Participants

Measure	ACAM-FLU-A Adjuvanted With Alhydrogel n = 22	ACAM-FLU-A Adjuvanted With Stimulon® QS-21 n = 23	ACAM FLU A Without Adjuvant n = 21	Saline Placebo n = 21
Blood and Lymphatic System Disorders	2	2	1	0
Cardiac Disorders	0	1	0	0
Ear and Labyrinth Disorders	0	0	0	1
Eye Disorders	1	0	0	0
Gastrointestinal Disorders	4	7	4	5
General and Administration Site Disorders	21	22	18	10
Hepatobiliary Disorders	0	1	0	0
Immune System Disorders	1	0	0	0

Population analysed: Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.

Primary outcome: Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Time frame: Day 0 through Day 7 post-vaccination. Number. Unit: Participants

Measure	ACAM-FLU-A Adjuvanted With Alhydrogel n = 22	ACAM-FLU-A Adjuvanted With Stimulon® QS-21 n = 23	ACAM FLU A Without Adjuvant n = 21	Saline Placebo n = 21
Lymph Node Pain (Post-dose 1)	1	0	1	0
Pyrexia (Temperature; [Post-dose 1])	3	3	0	1
Chills (Post-dose 1)	0	2	0	1
Constipation (Post-dose 1)	0	0	0	1
Diarrhoea (Post-dose 1)	2	0	1	2
Fatigue Post (Post-dose 1)	4	6	1	3
Headache (Post-dose 1)	4	6	1	0
Malaise (Post-dose 1)	1	3	1	1

Primary outcome: Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Time frame: Day 0 through Day 60 post-vaccination 1. Number. Unit: Participants

Measure	ACAM-FLU-A Adjuvanted With Alhydrogel n = 22	ACAM-FLU-A Adjuvanted With Stimulon® QS-21 n = 23	ACAM FLU A Without Adjuvant n = 21	Saline Placebo n = 21
Alanine Aminotranferase Increase	1	2	2	1
Aspartate Aminotransferase Increase	0	3	0	0
Blood Bilirubin Decreased	2	7	7	3
Blood Bilirubin Increased	0	3	0	0
Blood Creatine Increased	0	1	0	0
Blood Creatine Phosphokinase Increased	6	5	3	4
Blood Creatinine Decreased	0	0	0	1
Blood Creatinine Increased	6	4	6	4

Population analysed: Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).

Primary outcome: Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine

Time frame: Day 15 through Month 10 Post-vaccination 1. Number. Unit: Participants

Measure	ACAM-FLU-A Adjuvanted With Alhydrogel n = 19	ACAM-FLU-A Adjuvanted With Stimulon® QS-21 n = 20	ACAM FLU A Without Adjuvant n = 14	Saline Placebo n = 18
Day 15 (N = 19, 20, 14, 18)	0	12	2	0
Day 30 (N = 19, 20, 14, 18)	0	9	2	0
Day 45 (N = 19, 20, 14, 18)	6	19	9	1
Day 60 (N = 19, 20, 14, 18)	7	18	6	0
Month 4 (N = 19, 20, 13, 18)	4	16	5	1
Month 10 (N = 19, 19, 12, 15)	0	8	2	0

Population analysed: Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACAM-FLU-A Adjuvanted With Alhydrogel	1 of 22 (4.5%)	22 of 22 (100%)	Not reported
ACAM-FLU-A Adjuvanted With Stimulon® QS-21	0 of 23 (0%)	23 of 23 (100%)	Not reported
ACAM FLU A Without Adjuvant	1 of 21 (4.8%)	20 of 21 (95.2%)	Not reported
Saline Placebo	1 of 21 (4.8%)	15 of 21 (71.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23527091Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.

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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.

Medical Director study director

Sanofi Pasteur Inc

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Influenza A Vaccine: ACAM FLU-A in people with Influenza, run by Sanofi at 3 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 4 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 2012). 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 Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. (time frame: Day 0 through Day 60 post-vaccination). 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 NCT00819013, 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 19 Jan 2012.