InfluenzaPhase 4NCT00389532

Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

A Phase 4 study testing Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) 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

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… 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?: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Sep 2008
Phase: Phase 4
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 reasonably 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 3.

Show all 17Show fewer

Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1.
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 abuse of alcohol or drug addiction 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: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)

Conditions: Influenza
Being tested: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Keywords: Influenza, 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.

Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)Biological
Also called 2006-2007 Fluzone® vaccine
Influenza vaccine
Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)Biological
Also called 2006-2007 Fluzone® vaccine
Influenza vaccine

Study groups in NCT00389532
Study group	Role	What they receive
1	Experimental	aged 19 to 59 years Receives: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
2	Experimental	aged ≥ 60 years Receives: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)

What is being measured

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

Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Measured: 0-3 days post-vaccination
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
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.

Oct 2006Sep 2008

First posted19 Oct 2006 (estimated)
Study startOct 2006
Primary completionApr 2008
Study completionSep 2008

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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00389532
Sponsor's protocol ID: GRC35
Status last verified: Apr 2016
First submitted: 18 Oct 2006
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: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
ClinicalTrials.gov ID: NCT00389532
Acronym / sponsor ID: GRC35
Conditions: Influenza
Keywords: Influenza, Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Apr 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 19 Oct 2006 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)aged 19 to 59 years
2	Experimental	Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)aged ≥ 60 years

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 reasonably 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 (17 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
Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)Also: 2006-2007 Fluzone® vaccineInfluenza vaccine	Biological	1
Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)Also: 2006-2007 Fluzone® vaccineInfluenza vaccine	Biological	2

Primary outcome

Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Time frame: 0-3 days post-vaccination
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
Time frame: 21 days post-vaccination
GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.

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
Aged 18 to 59 Years	60	60
Aged ≥ 60 Years	56	56

Primary outcome: Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination

Time frame: 0-3 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Aged 18 to 59 Years n = 60	Aged ≥ 60 Years n = 56
Any Solicited Injection Site Reaction	78	38
Any Pain	78	30
Grade 3 Pain (Incapacitating)	0	0
Any Redness	7	9
Grade 3 Redness (≥ 5.0 cm)	0	4
Any Swelling	3	6
Grade 3 Swelling (≥ 5.0 cm)	0	0
Any Solicited Systemic Reaction	49	29

Population analysed: Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.

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

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

Measure	Aged 18 to 59 Years n = 55	Aged ≥ 60 Years n = 55
H1N1 FLU A/NEW CALEDONIA/20/99 - PRE	66.2 (41.6 to 105)	36.9 (28.5 to 47.7)
H1N1 FLU A/NEW CALEDONIA/20/99 - POST	214 (151 to 304)	77.0 (57.9 to 102)
H3N2 FLU A/WISCONSIN/67/2005 - PRE	67.9 (44.4 to 104)	110 (70.8 to 170)
H3N2 FLU A/WISCONSIN/67/2005 - POST	453 (334 to 613)	513 (363 to 726)
B FLU B/MALAYSIA SPLIT/2506/2004 - PRE	117 (83.5 to 165)	195 (157 to 241)
B FLU B/MALAYSIA SPLIT/2506/2004 - POST	788 (589 to 1054)	597 (477 to 748)

Population analysed: Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population

Adverse events

Time frame: Up to 28 days post-vaccination. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aged 18 to 59 Years	0 of 60 (0%)	15 of 60 (25%)	Not reported
Aged ≥ 60 Years	0 of 56 (0%)	2 of 56 (3.6%)	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 4 study testing Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) 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 17 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination (time frame: 0-3 days post-vaccination). 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 NCT00389532.

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.