InfluenzaPhase 2NCT00524940

Trial to Describe the Safety and Immunogenicity of Fluzone®

A Phase 2 study testing Inactivated, Split-Virion Influenza Virus in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site 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

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Inactivated, Split-Virion Influenza Virus
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Dec 2007
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant aged 18 years or older on the day of inclusion.
Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Participant is in good health as assessed by the investigator.
Participant willing and able to meet protocol requirements.
Participant willing and able to give informed consent.
For a woman, inability to bear a child or negative serum/urine pregnancy test.

Who cannot join

Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2.

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Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
Receipt of blood or blood products within the 3 months preceding enrollment in the study.
Diabetes mellitus requiring pharmacological control.
Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
Current alcohol or drug use that may interfere with the subject's ability to comply with trial procedures.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Prior personal history of Guillain-Barré syndrome.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.

Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.

Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Conditions: Influenza
Being tested: Inactivated, Split-Virion Influenza Virus
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine
Medical subject headings: Influenza, Human

What participants receive

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

Inactivated, Split-Virion Influenza VirusBiological
Also called Fluzone®
0.5 mL, Intramuscular

Study groups in NCT00524940
Study group	Role	What they receive
Study Group	Experimental	Not described Receives: Biological: Inactivated, Split-Virion Influenza Virus

What is being measured

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

Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Measured: 0-3 days post-vaccination and entire study duration
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
Measured: 21 days post-vaccination

Timeline

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

Aug 2007Dec 2007

First posted5 Sep 2007 (estimated)
Study startAug 2007
Primary completionSep 2007
Study completionDec 2007

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.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00524940
Sponsor's protocol ID: GRC37
Status last verified: Apr 2016
First submitted: 4 Sep 2007
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)
ClinicalTrials.gov ID: NCT00524940
Acronym / sponsor ID: GRC37
Conditions: Influenza
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Sep 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 5 Sep 2007 (estimated)
Results: Posted 30 Mar 2009

Clinical summary

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

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.

Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Group	Experimental	Biological: Inactivated, Split-Virion Influenza Virus

Who may qualify

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

Key inclusion criteria (6 listed)

Participant aged 18 years or older on the day of inclusion.
Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Participant is in good health as assessed by the investigator.
Participant willing and able to meet protocol requirements.
Participant willing and able to give informed consent.

Key exclusion criteria (16 listed)

Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.

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
Inactivated, Split-Virion Influenza VirusAlso: Fluzone®0.5 mL, Intramuscular	Biological	Study Group

Primary outcome

Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
Time frame: 0-3 days post-vaccination and entire study duration
Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
Time frame: 21 days post-vaccination
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.

Results and safety

Results posted to the registry on 30 Mar 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	124	124

Primary outcome: Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.

Time frame: 0-3 days post-vaccination and entire study duration. Number. Unit: Participants

Measure	Study Group n = 124
Any Solicited Injection Site Reaction	62
Any Pain	57
Grade 3 Pain (Incapacitating)	0
Any Redness	9
Grade 3 Redness (≥5.0 cm)	0
Any Swelling	7
Grade 3 Swelling (≥ 5.0 cm)	1
Any Induration	8

Population analysed: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.

Primary outcome: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.

Time frame: 21 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Study Group n = 112
H1N1 A/Solomon Islands/3/2006 - PRE	30.7 (23.4 to 40.2)
H1N1 A/Solomon Islands/3/2006 - POST	234.1 (180.6 to 303.5)
H3N2 A/Wisconsin/67/2005 - PRE	88.1 (66.7 to 116.2)
H3N2 A/Wisconsin/67/2005 - POST	347.9 (281.0 to 430.7)
B/Malaysia/2506/2004 - PRE	13.0 (11.0 to 15.4)
B/Malaysia/2506/2004 - POST	35.9 (29.4 to 43.8)

Population analysed: The GMT were evaluated in the per-protocol Population

Adverse events

Time frame: Adverse events data were collected from the day of vaccination to 21 days post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 124 (0%)	57 of 124 (46%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inactivated, Split-Virion Influenza Virus in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site 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 6 inclusion and 16 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 30 Mar 2009). 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?

Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. (time frame: 0-3 days post-vaccination and entire study duration). The study lists 2 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 NCT00524940.

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 14 Apr 2016.