InfluenzaPhase 1/2NCT00858468
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
A Phase 1/2 study testing Influenza virus vaccine (2004-2005 Formulation) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 8 sites in United States.
Trial summary
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Read more about this study
- Who is it for?
- Ages 2 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza virus vaccine (2004-2005 Formulation)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 1/2
- 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 2 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
- Considered to be in good health on the basis of reported medical history and history-directed physical examination.
- Available for the duration of the study.
- Parent/guardian willing and able to provide informed consent.
- Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
Who cannot join
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- Receipt of any vaccine in the 7 days prior to enrollment.
- An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Known bleeding disorder.
- Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
Show all 15Show fewer
- 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 could interfere with trial conduct or completion.
- Known HIV-positive or HBsAg-positive mother.
- Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
- Blood or blood-derived products received in the past 2 months.
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Akron, Ohio, 44308
Study site
Dayton, Ohio, 45404
Study site
Durham, North Carolina, 27705
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30062
Study site
Norfolk, Virginia, 23510
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Seattle, Washington, 98101
About this study
Official title: Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
Primary Objective:
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.
Observational Objective:
To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Read the detailed description
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
- Conditions
- Influenza
- Being tested
- Influenza virus vaccine (2004-2005 Formulation)
- 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 (2004-2005 Formulation)Biological
Also called Fluzone® Preservative-free
0.25 mL, Intramuscular
Influenza virus vaccine (2004-2005 Formulation)Biological
Also called Fluzone® Preservative-free
0.25 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants aged 6 to 12 Weeks at enrollment Receives: Biological: Influenza virus vaccine (2004-2005 Formulation) |
| Group 2 | Experimental | Participants aged 24 to 36 Weeks at enrollment Receives: Biological: Influenza virus vaccine (2004-2005 Formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
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.
- First posted9 Mar 2009 (estimated)
- Study startApr 2005
- Primary completionJun 2006
- Study completionDec 2006
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 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
- NCT00858468
- Sponsor's protocol ID
- GRC27
- Status last verified
- Apr 2016
- First submitted
- 5 Mar 2009
- 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
- Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age
- ClinicalTrials.gov ID
- NCT00858468
- Acronym / sponsor ID
- GRC27
- Conditions
- Influenza
- Keywords
- Influenza, Influenza vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 31 Jul 2009
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 describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.
Observational Objective:
To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Detailed description
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Influenza virus vaccine (2004-2005 Formulation)Participants aged 6 to 12 Weeks at enrollment |
| Group 2 | Experimental | Biological: Influenza virus vaccine (2004-2005 Formulation)Participants aged 24 to 36 Weeks at enrollment |
Who may qualify
- Ages
- 2 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
- Considered to be in good health on the basis of reported medical history and history-directed physical examination.
- Available for the duration of the study.
- Parent/guardian willing and able to provide informed consent.
Key exclusion criteria (15 listed)
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- Receipt of any vaccine in the 7 days prior to enrollment.
- An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) 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 (2004-2005 Formulation)Also: Fluzone® Preservative-free0.25 mL, Intramuscular | Biological | Group 1 |
| Influenza virus vaccine (2004-2005 Formulation)Also: Fluzone® Preservative-free0.25 mL, Intramuscular | Biological | Group 2 |
Primary outcome
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Time frame: Day 0 to Day 7 post-vaccination
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Influenza virus vaccine (2004-2005 Formulation) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 8 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 7 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 8 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 31 Jul 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 Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. (time frame: Day 0 to Day 7 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.