Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258830
First received: November 24, 2005
Last updated: April 15, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years.
To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years.
To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), 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: Fluzone®: Influenza Virus Vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 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:
- Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ] [ Designated as safety issue: Yes ]
- Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)
| Enrollment: | 120 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Age 18 to 59 years |
Biological: Fluzone®: Influenza Virus Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
|
| Experimental: Age 60 years and older |
Biological: Fluzone®: Influenza Virus Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
|
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 any trial vaccination.
- 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 posed a health risk to the subject if enrolled or interfered 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 interfered with the subject's ability to comply with trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00258830 History of Changes |
| Other Study ID Numbers: | GRC25 |
| Study First Received: | November 24, 2005 |
| Results First Received: | March 5, 2009 |
| Last Updated: | April 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
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 21, 2013