InfluenzaPhase 4NCT00743275

A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

A Phase 4 study testing Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) 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 describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation. To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance… 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?: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Nov 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 is 18 years of age or older on the day of inclusion.
Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Participant in reasonably good health as assessed by the Investigator.
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 in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or 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 condition 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 and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Current use of alcohol or recreational drugs 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. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.

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 Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Conditions: Influenza
Being tested: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
Keywords: Influenza
Medical subject headings: Influenza, Human

What participants receive

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

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)Biological
Also called Fluzone®
0.5 mL, intramuscular

Study groups in NCT00743275
Study group	Role	What they receive
Study Group	Experimental	Participants received one dose of Fluzone® vaccine on Day 0. Receives: Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

What is being measured

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

Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Measured: Days 0-3 post-vaccination
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
Measured: Day 0 and 21 days post-vaccination
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Measured: 21 days post-vaccination
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation
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 2008Nov 2008

First posted28 Aug 2008 (estimated)
Study startAug 2008
Primary completionNov 2008
Study completionNov 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00743275
Sponsor's protocol ID: GRC41
Status last verified: Apr 2016
First submitted: 27 Aug 2008
Last updated: 16 May 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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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
ClinicalTrials.gov ID: NCT00743275
Acronym / sponsor ID: GRC41
Conditions: Influenza
Keywords: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 28 Aug 2008 (estimated)
Results: Posted 23 Feb 2010

Clinical summary

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

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Group	Experimental	Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)Participants received one dose of Fluzone® vaccine on Day 0.

Who may qualify

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

Key inclusion criteria (5 listed)

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

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 in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or 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
Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)Also: Fluzone®0.5 mL, intramuscular	Biological	Study Group

Primary outcome

Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Time frame: Days 0-3 post-vaccination
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
Time frame: Day 0 and 21 days post-vaccination
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
Time frame: 21 days post-vaccination
Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Time frame: 21 days post-vaccination
Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation

Results and safety

Results posted to the registry on 23 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age 18-60 Years	59	59
Age 61 Years and Older	61	60

Primary outcome: Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.

Time frame: Days 0-3 post-vaccination. Number. Unit: Participants

Measure	Age 18-60 Years n = 59	Age 61 Years and Older n = 61
Any Solicited Injection Site Reaction	35	18
Any Pain	34	16
Grade 3 Pain (Incapacitating)	0	1
Any Erythema (Redness)	7	2
Grade 3 Erythema (Redness)	0	0
Any Swelling	4	1
Grade 3 Swelling (≥ 5 cm)	0	1
Any Induration	5	1

Population analysed: Safety profile was assessed in the intent-to-treat (ITT) population

Primary outcome: Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation

Time frame: Day 0 and 21 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Age 18-60 Years n = 50	Age 61 Years and Older n = 49
A/Brisbane/59/2007 (H1N1) IVR-148 Pre-dose	26.9 (18.8 to 38.6)	16.9 (13.3 to 21.4)
A/Uruguay (H3N2) X-175-C Pre-dose	34.9 (22.5 to 54.2)	31.5 (21.5 to 46.0)
B/Florida/04/2006 Pre-dose	28.5 (21.0 to 38.6)	21.6 (16.6 to 28.1)
A/Brisbane/59/2007 (H1N1) IVR-148 Post-dose	130.9 (91.1 to 188.1)	46.1 (35.0 to 60.7)
A/Uruguay (H3N2) X-175-C Post-dose	528.7 (351.1 to 796.3)	300.3 (217.9 to 413.7)
B/Florida/04/2006 Post-dose	84.0 (64.9 to 108.6)	56.2 (40.9 to 77.2)

Population analysed: Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Primary outcome: Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)

Time frame: 21 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Age 18-60 Years n = 50	Age 61 Years and Older n = 49
A/Brisbane/59/2007 (H1N1) IVR-148	88	63
A/Uruguay (H3N2) X-175-C	98	98
B/Florida/04/2006	82	67

Population analysed: Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Primary outcome: Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)

Time frame: 21 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Age 18-60 Years n = 50	Age 61 Years and Older n = 49
A/Brisbane/59/2007 (H1N1) IVR-148	42	33
A/Uruguay (H3N2) X 175-C	77	84
B/Florida/04/2006	36	31

Population analysed: Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Adverse events

Time frame: Adverse events data were collected throughout the study from Day 0 to Day 21.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age 18-60 Years	0 of 59 (0%)	34 of 59 (57.6%)	Not reported
Age 61 Years and Older	0 of 61 (0%)	16 of 61 (26.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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 Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) 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 5 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 16 May 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 23 Feb 2010). 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 With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. (time frame: Days 0-3 post-vaccination). The study lists 4 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 NCT00743275.

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 16 May 2016.