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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554333
• Other study ID #: FID01C
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2007
• Last updated: March 15, 2018
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flu-ID 15µg
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
• Inactivated adjuvanted Influenza Vaccine
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.		21 days
Secondary	Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]		21 days
Secondary	Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre =40 (1/dil)] on Day 21		21 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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]		3 days
Secondary	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		21 days (plus or minus 3 days)
Secondary	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		21 days (plus or minus 3 days)
Secondary	Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale		1 day (day of vaccination)
Secondary	Answers to the Vaccination Comfort Questionnaire completed on D21		21 days