Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

Influenza Clinical Trial

Official title:

Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703651
• Other study ID #: GID02
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2008
• Last updated: January 9, 2014
• Start date: September 2003
• Est. completion date: July 2006

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.

Primary Objective:

To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.

Secondary Objective:

To evaluate the safety profile during the 21-day period following each vaccination in each study group

Description:

This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: July 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 57 Years

Eligibility

Inclusion Criteria :

• Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)

• For woman of child-bearing potential, negative urine pregnancy test at V#01

• Use of effective contraception prior to and during the trial

• Subject available during the trial period

• Subject able to read and understand the informed consent form

• Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).

Exclusion Criteria :

• Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9

• Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)

• Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)

• Vaccination against influenza within the 6 months preceding V#01

• Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02

• Breast-feeding

• Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing

• Immunoglobulin injection within the 3 months preceding V#01

• Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)

• Subject having received extracted pituitary hormones

• Subjects who participated in the GID01 study (Lithuanian centers)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza
• Influenza, Human
• Myxovirus Infection
• Orthomyxoviridae Infection
• Orthomyxoviridae Infections

Intervention

Biological:
• Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years
• Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years.
• Inactivated, split-virion influenza vaccine
0.5 mL, IM. 1 injection/year for 3 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.		21days post-vaccination	No
Primary	To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine		21 days post-vaccination and entire study duration	Yes

External Links

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