NCT00554333

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
795

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
2 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

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

November 5, 2007

Last Update Submit

March 15, 2018

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.

    21 days

Secondary Outcomes (10)

  • Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]

    21 days

  • Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21

    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

    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)

    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

    7 days

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

Biological: Flu-ID 15μg

2

ACTIVE COMPARATOR

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Biological: Inactivated adjuvanted Influenza Vaccine

Interventions

Flu-ID 15μgBIOLOGICAL

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

1
Inactivated adjuvanted Influenza VaccineBIOLOGICAL

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Massemen, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Angers, France

Location

Unknown Facility

Cherbourg, France

Location

Unknown Facility

Laval, France

Location

Unknown Facility

Seysses, France

Location

Unknown Facility

Tiercé, France

Location

Related Publications (1)

  • Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.

    PMID: 20504306DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Director

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations

FR(5)BE(3)