Prophylaxis of influenza (2013-2014 Northern Hemisphere Season) MedDRA version: 16.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862
Conditions
Interventions
Trade Name: IDflu
Product Name: IDflu 9µg
Product Code: 415
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza virus (split virion, inactivated) A/H1N1-like strain
Other desc
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged over 18 years on the day of inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: - Subject is pregnant, or lactating, or of childbearing potential - Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination - Vaccination against flu in the previous 12 months if administered in the context of a clinical trial, or in the previous 6 months if administered in the context of a flu vaccination campaign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the compliance, in terms of immunogenicity, of the ID influenza vaccine NH 2013-2014 formulation with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups To describe the safety of the ID influenza vaccine NH 2013-2014 formulation in both age groups;Secondary Objective: ;Primary end point(s): Immunogenicity will be evaluated before and 21 days after injection of the ID influenza vaccine using the Hemagglutination Inhibition (HAI) technique. For each vaccine strain, anti-hemagglutinin (HA) antibodytiters will be expressed as HAI titers obtained in duplicates at each time point, Day (D) 0 and D21 Safety will be evaluated within 21 days of injection of the ID influenza vaccine NH 2013-2014 formulation in subjects aged 18 to 59 years and in subjects aged 60 years or older. • The occurrence of the following reactions during the first 3 days following vaccination will be more specifically reported (as defined by the CHMP NfG CPMP/BWP/214/96): • Injection site induration =50 mm and persisting for more than 3 consecutive days • Injection site ecchymosis • Temperature above 38°C for 24 hours or more • Malaise • Shivering • Occurrence of unsolicited systemic adverse events (AEs) reported in the 30 minutes following the vaccine injection • Occurrence of solicited (prelisted in the subject diary and the electronic Case Report Form [CRF]) injection site reactions and systemic reactions within 7 days of vaccine injection • Occurrence of unsolicited (spontaneously reported) AEs within 21 days of vaccine injection • Occurrence of serious adverse events (SAEs) from Visit 1 up to the end of the study (Visit 2);Timepoint(s) of evaluation of this end point: D21 after vaccination | — |
Countries
France
Contacts
Public ContactMedical Product Leader
Sanofi Pasteur
Outcome results
None listed