InfluenzaPhase 4NCT00390884
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
A Phase 4 study testing Influenza Virus Vaccine, Fluzone® in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 5 sites in United States.
Trial summary
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation). Read more about this study
- Who is it for?
- Ages 11 to 14 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
- 173 participants
- Where
- 5 sitesUnited 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 11 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
- Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
- Available for the duration of the study.
- Parent/legal representative willing and able to provide informed consent.
- Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
- Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.
Who cannot join
- Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
- An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Known bleeding disorder.
- Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in the study.
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- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay, neurologic disorder, or seizure disorder.
- Chronic medical, congenital, or developmental disorder that, in the opinion of the investigator, could interfere with trial conduct or completion.
- Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
- Known HIV, Hepatitis B, or Hepatitis C infection.
- Administration of immune globulin or other blood products within the last three months, or 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.
- Prior personal history of Guillain-Barré syndrome.
- Any condition that, 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Layton, Utah, 84041
Study site
Pleasant Grove, Utah, 84062
Study site
Provo, Utah, 84604
Study site
Salt Lake City, Utah, 84107
Study site
South Jordan, Utah, 84095
About this study
Official title: Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
- Conditions
- Influenza
- Being tested
- Influenza Virus Vaccine, Fluzone®
- Keywords
- Fluzone®, Influenza, Influenza virus infection, 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, Fluzone®Biological
Also called Fluzone®
0.25 mL, Intramuscular
Influenza Virus Vaccine, Fluzone®Biological
Also called Fluzone®
0.25 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Fluzone®-Primed Group | Experimental | Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. Receives: Biological: Influenza Virus Vaccine, Fluzone® |
| Fluzone®-Naive Group | Experimental | Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. Receives: Biological: Influenza Virus Vaccine, Fluzone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Measured: Day 28 Post-vaccination
Secondary outcomes (1)
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Measured: Day 28 Post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- 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
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, sanofi pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390884
- Sponsor's protocol ID
- GRC29
- Status last verified
- Apr 2016
- First submitted
- 20 Oct 2006
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo
- ClinicalTrials.gov ID
- NCT00390884
- Acronym / sponsor ID
- GRC29
- Conditions
- Influenza
- Keywords
- Fluzone®, Influenza, Influenza virus infection, Influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Posted 31 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluzone®-Primed Group | Experimental | Biological: Influenza Virus Vaccine, Fluzone®Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. |
| Fluzone®-Naive Group | Experimental | Biological: Influenza Virus Vaccine, Fluzone®Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. |
Who may qualify
- Ages
- 11 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
- Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
- Available for the duration of the study.
- Parent/legal representative willing and able to provide informed consent.
- Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
Key exclusion criteria (15 listed)
- Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
- An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Known bleeding disorder.
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 | Biological | Fluzone®-Primed Group |
| Influenza Virus Vaccine, Fluzone®Also: Fluzone®0.25 mL, Intramuscular | Biological | Fluzone®-Naive Group |
Primary outcome
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Time frame: Day 28 Post-vaccination
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
1 secondary outcome
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Time frame: Day 28 Post-vaccination
Results and safety
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
5 sites 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 5 sites 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 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 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 5 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 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 31 Dec 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 Seroprotected Participants Post-vaccination With Fluzone® (time frame: Day 28 Post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.