NCT00703651

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

2.7 years

First QC Date

June 19, 2008

Last Update Submit

January 9, 2014

Conditions

InfluenzaOrthomyxoviridae InfectionMyxovirus Infection

Keywords

InfluenzaOrthomyxoviridae InfectionInactivated, Split-virion influenza vaccineIntradermal injectionAdults.

Outcome Measures

Primary Outcomes (2)

  • To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.

    21days post-vaccination

  • To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine

    21 days post-vaccination and entire study duration

Study Arms (3)

1

EXPERIMENTAL
Biological: Inactivated, split-virion influenza vaccine

2

EXPERIMENTAL
Biological: Inactivated, split-virion influenza vaccine

3

ACTIVE COMPARATOR
Biological: Inactivated, split-virion influenza vaccine

Interventions

Inactivated, split-virion influenza vaccineBIOLOGICAL

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

1

Eligibility Criteria

Age18 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Gribomont, Belgium

Location

Unknown Facility

Kraainem, Belgium

Location

Unknown Facility

Linkebeek, Belgium

Location

Unknown Facility

Molenbeek, Belgium

Location

Unknown Facility

Thuin, Belgium

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Kaunas, Lithuania

Location

Unknown Facility

Vilnius, Lithuania

Location

Related Publications (1)

  • Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13.

    PMID: 19341446DERIVED

Related Links

MeSH Terms

Conditions

Influenza, HumanOrthomyxoviridae Infections

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Monitor

    Sanofi Pasterur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 23, 2008

Study Start

September 1, 2003

Primary Completion

May 1, 2006

Study Completion

July 1, 2006

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

BE(5)CZ(1)LI(2)