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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Influenza Orthomyxoviridae Infection Myxovirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Inactivated, split-virion influenza vaccine

Intervention Type BIOLOGICAL

0.1 mL, ID. 1 injection/year for 3 years

2

Group Type EXPERIMENTAL

Inactivated, split-virion influenza vaccine

Intervention Type BIOLOGICAL

0.1 mL, ID. 1 injection/year for 3 years.

3

Group Type ACTIVE_COMPARATOR

Inactivated, split-virion influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL, IM. 1 injection/year for 3 years

Interventions

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Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years

Intervention Type BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years.

Intervention Type BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.5 mL, IM. 1 injection/year for 3 years

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaxigrip®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes