Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00389532
First received: October 18, 2006
Last updated: September 14, 2009
Last verified: September 2009
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Purpose
To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination [ Time Frame: 0-3 days post-vaccination ] [ Designated as safety issue: Yes ]
- Geometric Mean Titers (GMTs) of Serum Hemagglutinnation Inhibition Antibodies Pre-vaccination and Post-vaccination [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 116 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
aged 19 to 59 years
|
Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Influenza vaccine
Other Name: 2006-2007 Fluzone® vaccine
|
|
Experimental: 2
aged ≥ 60 years
|
Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Influenza vaccine
Other Name: 2006-2007 Fluzone® vaccine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Participant aged 18 years or older on the day of inclusion.
- Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Participant is in reasonably good health as assessed by the investigator.
- Participant willing and able to meet protocol requirements.
- Participant willing and able to give informed consent.
- For a woman, inability to bear a child or negative serum/urine pregnancy test.
Exclusion Criteria:
- Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
- An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
- Self-reported 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 in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
- Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1.
- Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
- Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
- Receipt of blood or blood products within the 3 months preceding enrollment in the study.
- Diabetes mellitus requiring pharmacological control.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- Person deprived of freedom by an administrative or court order (having legal or medical guardian).
- For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Prior personal history of Guillain-Barré syndrome.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00389532 History of Changes |
| Other Study ID Numbers: | GRC35 |
| Study First Received: | October 18, 2006 |
| Results First Received: | February 24, 2009 |
| Last Updated: | September 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Influenza Influenza Vaccine |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013