Orthomyxoviridae InfectionPhase 2NCT00391391

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

A Phase 2 study testing Split, Inactivated, Trivalent Influenza Vaccine and Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) in people with Orthomyxoviridae Infection and Influenza, run by Sanofi at 19 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

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Read more about this study

Who is it for?: Ages 6 months to 8 yearsHealthy volunteers can take part
Conditions the study is for: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
What is being tested?: Split, Inactivated, Trivalent Influenza Vaccine and Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 520 participants
Where: 19 sitesUnited States
Study dates: Oct 2006to Oct 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 6 months to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
Subject is healthy, as determined by medical history.
Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Personal or family history of Guillain-Barré Syndrome.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion

Show all 15Show fewer

Received blood or blood-derived products in the previous 3 months.
Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
History of seizures.
Received antibiotics therapy within 72 hours preceding the trial vaccination.
Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
Any condition, which in the opinion of the investigator would pose a health risk to the participant.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Study site
Bellflower, California, 90706
Study site
Bossier City, Louisiana, 71111
Study site
Brainerd, Minnesota, 56401
Study site
Cleveland, Ohio, 44121
Study site
Downey, California, 90241
Study site
Erie, Pennsylvania, 16505
Study site
Fort Worth, Texas, 76107
Study site
Fountain Valley, California, 92708
Study site
Harrisburg, Arkansas, 72432
Study site
Little Rock, Arkansas, 72205
Study site
Owensboro, Kentucky, 42303
Study site
Paramount, California, 90723
Study site
Pittsburgh, Pennsylvania, 15277
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
Shreveport, Louisiana, 71105
Study site
Trumann, Arkansas, 72472
Study site
Uniontown, Pennsylvania, 15401
Study site
Wexford, Pennsylvania, 15090

Other trials in United States

About this study

Official title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Being tested: Split, Inactivated, Trivalent Influenza Vaccine, Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Infants, children.
Medical subject headings: Orthomyxoviridae Infections, 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 VaccineBiological
Vaccine (infant dose)
Split, Inactivated, Trivalent Influenza VaccineBiological
Vaccine (children dose)
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Biological
Also called Fluzone® 2006/2007 Formulation.
Vaccine (infant dose)
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Biological
Also called Fluzone® 2006/2007 Formulation.
Vaccine (children dose)

Study groups in NCT00391391
Study group	Role	What they receive
1	Experimental	Split, Inactivated, Trivalent Influenza Vaccine Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine
2	Experimental	Split, Inactivated, Trivalent Influenza Vaccine Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine
3	Active comparator	Split, Inactivated, Trivalent Influenza Vaccine Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
4	Active comparator	Split, Inactivated, Trivalent Influenza Vaccine Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

What is being measured

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

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Measured: Day 0 and Day 28 post-vaccination

Secondary outcomes (5)

Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Measured: Day 28 post-vaccination
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Measured: Day 28 post-vaccination
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Measured: Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Measured: Day 0 to Day 7 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
Measured: Day 0 to Day 7 post-vaccination

Timeline

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

Oct 2006Oct 2007

First posted24 Oct 2006 (estimated)
Study startOct 2006
Primary completionMar 2007
Study completionOct 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 Orthomyxoviridae InfectionStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391391
Sponsor's protocol ID: FID07
Status last verified: Nov 2011
First submitted: 23 Oct 2006
Last updated: 1 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.
ClinicalTrials.gov ID: NCT00391391
Acronym / sponsor ID: FID07
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Infants, children.
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Mar 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 24 Oct 2006 (estimated)
Results: Posted 22 Nov 2011

Clinical summary

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

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: Split, Inactivated, Trivalent Influenza VaccineSplit, Inactivated, Trivalent Influenza Vaccine
2	Experimental	Biological: Split, Inactivated, Trivalent Influenza VaccineSplit, Inactivated, Trivalent Influenza Vaccine
3	Active comparator	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Split, Inactivated, Trivalent Influenza Vaccine
4	Active comparator	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Split, Inactivated, Trivalent Influenza Vaccine

Who may qualify

Ages: 6 months to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
Subject is healthy, as determined by medical history.
Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Key exclusion criteria (15 listed)

Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Personal or family history of Guillain-Barré Syndrome.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.

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 VaccineVaccine (infant dose)	Biological	1
Split, Inactivated, Trivalent Influenza VaccineVaccine (children dose)	Biological	2
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Also: Fluzone® 2006/2007 Formulation.Vaccine (infant dose)	Biological	3
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)Also: Fluzone® 2006/2007 Formulation.Vaccine (children dose)	Biological	4

Primary outcome

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Time frame: Day 0 and Day 28 post-vaccination
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

5 secondary outcomes

Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Time frame: Day 28 post-vaccination
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Time frame: Day 28 post-vaccination
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Time frame: Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Time frame: Day 0 to Day 7 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Time frame: Day 0 to Day 7 post-vaccination

Results and safety

Results posted to the registry on 22 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Fluzone ID at Age 6 to 35 Months	98	89
Group 2: Fluzone IM 6 to 35 Months Age Group	97	87
Group 3: Fluzone ID at 3 to 8 Years Age	161	138
Group 4: Fluzone IM 3 to 8 Years Age	164	145

Primary outcome: Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Time frame: Day 0 and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1: Fluzone ID at Age 6 to 35 Months n = 69	Group 2: Fluzone IM 6 to 35 Months Age Group n = 68	Group 3: Fluzone ID at 3 to 8 Years Age n = 115	Group 4: Fluzone IM 3 to 8 Years Age n = 120
Serogroup A/H1N1 Pre-vaccination	8.9 (7.1 to 11.2)	9.6 (7.5 to 12.3)	20.5 (15.6 to 26.9)	26.9 (19.6 to 37.1)
Serogroup A/H1N1 Post-vaccination 1	58.5 (28.6 to 119.4)	113.1 (59.9 to 213.7)	100.1 (55.0 to 182.1)	264.2 (162.8 to 428.9)
Serogroup A/H1N1 Post-vaccination 2	138.3 (105.2 to 181.8)	160.0 (123.7 to 206.9)	162.9 (128.7 to 206.3)	390.6 (308.2 to 495.0)
Serogroup A/H3N2 Pre-vaccination	22.4 (14.0 to 35.9)	20.9 (13.7 to 31.9)	222.2 (165.4 to 298.5)	171.0 (121.5 to 240.7)
Serogroup A/H3N2 Post-vaccination 1	341.8 (142.9 to 817.7)	566.9 (304.6 to 1054.9)	1012.5 (666.9 to 1537.2)	1256.9 (898.2 to 1758.8)
Serogroup A/H3N2 Post-vaccination 2	614.8 (471.3 to 802.0)	471.4 (368.0 to 603.7)	1111.0 (944.0 to 1307.5)	1344.4 (1146.1 to 1577.1)
Serogroup B Pre-vaccination	5.3 (4.9 to 5.8)	5.4 (5.0 to 5.9)	8.3 (7.1 to 9.7)	6.8 (6.0 to 7.7)
Serogroup B Post-vaccination 1	7.4 (4.4 to 12.5)	9.7 (4.2 to 22.1)	46.6 (23.3 to 93.3)	28.8 (16.0 to 52.0)

Population analysed: Geometric Mean Titers were determined in the per-protocol population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Fluzone ID at Age 6 to 35 Months	1 of 97 (1%)	51 of 97 (52.6%)	Not reported
Group 2: Fluzone IM 6 to 35 Months Age Group	1 of 97 (1%)	49 of 97 (50.5%)	Not reported
Group 3: Fluzone ID at 3 to 8 Years Age	1 of 160 (0.6%)	98 of 160 (61.3%)	Not reported
Group 4: Fluzone IM 3 to 8 Years Age	1 of 163 (0.6%)	90 of 163 (55.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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.

19 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 4 inclusion and 15 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 22 Nov 2011). 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?

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine (time frame: Day 0 and Day 28 post-vaccination). 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 NCT00391391.

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 1 Dec 2011.