InfluenzaPhase 4NCT00755274
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
A Phase 4 study testing Influenza Virus Vaccine No Preservative: Pediatric Dose in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
Trial summary
Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infections
- What is being tested?
- Influenza Virus Vaccine No Preservative: Pediatric Dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2009
- 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 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Who cannot join
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- 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 scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during 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 personal 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.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
Primary Objective:
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Read more
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
Read the detailed description
The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).
- Conditions
- Influenza, Orthomyxoviridae Infections
- Being tested
- Influenza Virus Vaccine No Preservative: Pediatric Dose
- Keywords
- Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus Vaccine No Preservative: Pediatric DoseBiological
Also called Fluzone®
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Influenza Virus Vaccine No Preservative: Pediatric DoseBiological
Also called Fluzone®
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Primed | Experimental | Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1 Receives: Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose |
| Group 2: Naive/Inadequately Primed | Experimental | Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1 Receives: Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Measured: Day 0 to Day 3 post-vaccination 1
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Measured: Day 0 to Day 3 post-vaccination 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- 32 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
- NCT00755274
- Sponsor's protocol ID
- GRC40
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2008
- 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
- Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
- ClinicalTrials.gov ID
- NCT00755274
- Acronym / sponsor ID
- GRC40
- Conditions
- Influenza, Orthomyxoviridae Infections
- Keywords
- Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 1 Apr 2010
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 provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
Detailed description
The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Primed | Experimental | Biological: Influenza Virus Vaccine No Preservative: Pediatric DoseHave received 2 or more lifetime Flu Vaccinations Prior to Visit 1 |
| Group 2: Naive/Inadequately Primed | Experimental | Biological: Influenza Virus Vaccine No Preservative: Pediatric DoseNever Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1 |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Key exclusion criteria (13 listed)
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- 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 scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during 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 No Preservative: Pediatric DoseAlso: Fluzone®0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months) | Biological | Group 1: Primed |
| Influenza Virus Vaccine No Preservative: Pediatric DoseAlso: Fluzone®0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months) | Biological | Group 2: Naive/Inadequately Primed |
Primary outcome
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Time frame: Day 0 to Day 3 post-vaccination 1
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Time frame: Day 0 to Day 3 post-vaccination 2
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
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.
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 No Preservative: Pediatric Dose in people with Influenza and Orthomyxoviridae Infections, 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 13 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 1 Apr 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 Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 (time frame: Day 0 to Day 3 post-vaccination 1). The study lists 2 primary outcomes in all. 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.