Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine - Full Text View

Sponsored by:	Sanofi Pasteur MSD
Information provided by:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT00554333

Purpose

Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

Immunogenicity
- To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
- To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
Safety

- To describe the safety profile after vaccination in each group
Acceptability
- To describe the pain at the injection site
- To describe the comfort of the injection

Condition	Intervention	Phase
Influenza	Biological: Flu-ID 15μg Biological: Inactivated adjuvanted Influenza Vaccine	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multi-Centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:

Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. [ Time Frame: 21 days ]

Secondary Outcome Measures:

Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0] [ Time Frame: 21 days ]
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21 [ Time Frame: 21 days ]
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0 [ Time Frame: 21 days ]
Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil) [ Time Frame: 21 days ]
Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination [ Time Frame: 7 days ]
Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96] [ Time Frame: 3 days ]
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2 [ Time Frame: 21 days (plus or minus 3 days) ]
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2 [ Time Frame: 21 days (plus or minus 3 days) ]
Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale [ Time Frame: 1 day (day of vaccination) ]
Answers to the Vaccination Comfort Questionnaire completed on D21 [ Time Frame: 21 days ]

Estimated Enrollment:	790
Study Start Date:	October 2007
Study Completion Date:	December 2007

Arms	Assigned Interventions
1: Experimental Inactivated Split-Virion Influenza Vaccine for Intradermal Route	Biological: Flu-ID 15μg Inactivated Split-Virion Influenza Vaccine for Intradermal Route
2: Active Comparator Inactivated adjuvanted Influenza Vaccine for Intramuscular Route	Biological: Inactivated adjuvanted Influenza Vaccine Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged 65 years or older on the day of inclusion

Exclusion Criteria:

Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Unstable chronic illness
Congenital or acquired immunodeficiency,
Any blood or blood-derived product in the past 3 months
Current abuse of alcohol or drug addiction
Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
Any vaccination against influenza in the past 6 months
Subjects who previously received a vaccination against influenza by intradermal route

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554333

Locations

Belgium

Wilrijk, Belgium

Massemen, Belgium

Antwerpen, Belgium
France

Angers, France

Seysses, France

Laval, France

Cherbourg, France

Tierce, France

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

Emilio LEDESMA, MD

Sanofi Pasteur MSD

More Information

Responsible Party:	Sanofi Pasteur MSD ( Emilio LEDESMA MD )
Study ID Numbers:	FID01C
Study First Received:	November 5, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00554333
Health Authority:	France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009