Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

NCT00389532 | Completed Phase 4 Results

• 1 other identifier: GRC35
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

Influenza; Influenza Vaccine

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination

  Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)

  0-3 days post-vaccination

• Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination

  GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.

  21 days post-vaccination

Study Arms (2)

1

EXPERIMENTAL

aged 19 to 59 years

Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)

2

EXPERIMENTAL

aged ≥ 60 years

Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)

Interventions

Influenza Virus Vaccine (2006-2007 Fluzone® vaccine) BIOLOGICAL

Influenza vaccine

Also known as: 2006-2007 Fluzone® vaccine

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi pasteur Inc

RegistryContactUS@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 14, 2016
• Results First Posted: March 30, 2009

Record last verified: 2016-04

Locations

US (1)