InfluenzaPhase 4NCT00258817

Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

A Phase 4 study testing Influenza Virus 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 provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Read more about this study

Who is it for?: Ages 6 to 36 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza Virus Vaccine (Fluzone®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Aug 2007
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 6 to 36 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
Participant is available for the duration of the study.
Parent/legal acceptable representative is willing and able to provide informed consent.
Parent/legal acceptable representative is willing and able to meet protocol requirements.
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

Who cannot join

Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
Documented history of influenza infection.
An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.

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Personal or immediate family history of congenital immune deficiency.
Developmental delay, neurologic disorder, or seizure disorder.
Chronic medical, congenital, or developmental disorder.
Known Human immunodeficiency virus (HIV)-positive mother.
Prior history of Guillain-Barré syndrome.
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Norfolk, Virginia, 23510

Other trials in United States

About this study

Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

Conditions: Influenza
Being tested: Influenza Virus Vaccine (Fluzone®)
Keywords: Fluzone®, Influenza Virus 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 (Fluzone®)Biological
Also called Fluzone®
0.25 mL, Intramuscular (Day 0 and Day 28)
Influenza Virus Vaccine (Fluzone®)Biological
Also called Fluzone®
0.25 mL, Intramuscular (Day 0)

Study groups in NCT00258817
Study group	Role	What they receive
Influenza Virus Vaccine Naïve	Experimental	Subjects have never received Influenza virus vaccine in the past Receives: Biological: Influenza Virus Vaccine (Fluzone®)
Influenza Virus Vaccine-primed	Experimental	Subjects have received Influenza virus vaccine in the past Receives: Biological: Influenza Virus Vaccine (Fluzone®)

What is being measured

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

Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.
Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
Measured: Day 14 post-vaccination

Timeline

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

Oct 2005Aug 2007

First posted28 Nov 2005 (estimated)
Study startOct 2005
Primary completionMar 2006
Study completionAug 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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00258817
Sponsor's protocol ID: GRC26
Status last verified: Apr 2016
First submitted: 24 Nov 2005
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 Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
ClinicalTrials.gov ID: NCT00258817
Acronym / sponsor ID: GRC26
Conditions: Influenza
Keywords: Fluzone®, Influenza Virus Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Mar 2006 (actual)
Study completion: Aug 2007 (actual)
First posted: 28 Nov 2005 (estimated)
Results: Posted 25 Mar 2009

Clinical summary

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

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

Study design

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

Arm	Type	Receives
Influenza Virus Vaccine Naïve	Experimental	Biological: Influenza Virus Vaccine (Fluzone®)Subjects have never received Influenza virus vaccine in the past
Influenza Virus Vaccine-primed	Experimental	Biological: Influenza Virus Vaccine (Fluzone®)Subjects have received Influenza virus vaccine in the past

Who may qualify

Ages: 6 to 36 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
Participant is available for the duration of the study.
Parent/legal acceptable representative is willing and able to provide informed consent.
Parent/legal acceptable representative is willing and able to meet protocol requirements.

Key exclusion criteria (12 listed)

Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
Documented history of influenza infection.
An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation 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 (Fluzone®)Also: Fluzone®0.25 mL, Intramuscular (Day 0 and Day 28)	Biological	Influenza Virus Vaccine Naïve
Influenza Virus Vaccine (Fluzone®)Also: Fluzone®0.25 mL, Intramuscular (Day 0)	Biological	Influenza Virus Vaccine-primed

Primary outcome

Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
Time frame: Day 14 post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)

Results and safety

Results posted to the registry on 25 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
Influenza Vaccine-naive Group	15	15
Influenza Vaccine-primed Group	15	15

Primary outcome: Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination

Time frame: Day 14 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Influenza Vaccine-naive Group n = 13	Influenza Vaccine-primed Group n = 14
Flu A/New Caledonia/20/99 (H1N1) - Pre	5.0 (5.0 to 5.0)	8.2 (4.3 to 15.6)
Flu A/New Caledonia/20/99 (H1N1) - Post	187.8 (105.4 to 334.5)	95.1 (44.0 to 205.9)
Flu A/New York/55/2004 (H3N2) - Pre	8.5 (4.9 to 14.7)	32.8 (10.9 to 98.4)
Flu A/New York/55/2004 (H3N2) - Post	328.6 (181.2 to 596.0)	249.8 (88.1 to 708.6)
Flu B/Jiangsu/10/2003 - Pre	9.2 (4.6 to 18.7)	5.3 (4.7 to 5.8)
Flu B/Jiangsu/10/2003 - Post	59.7 (22.7 to 156.9)	39.0 (17.2 to 88.7)

Population analysed: Geometric Mean Titers were assessed on the per-protocol population.

Adverse events

Time frame: Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza Vaccine-naive Group	0 of 15 (0%)	13 of 15 (86.7%)	Not reported
Influenza Vaccine-primed Group	0 of 15 (0%)	5 of 15 (33.3%)	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.

Clinical Trials study director

Sanofi Pasteur, a Sanofi Company

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 (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 6 inclusion and 12 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 25 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?

Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination (time frame: Day 14 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 NCT00258817.

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.