NCT01138397CompletedPhase 3

Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route)

Sanofi Pasteur, a Sanofi Company2 sites in 1 country129 target enrollmentStarted: June 2010Last updated: October 6, 2015

Conditions

Interventions

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 129
Locations: 2
Primary Endpoint: Information concerning the safety (solicited and unsolicited adverse events) of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96

Objectives:

To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine NH 2010-2011 formulation with the requirements of the CPMP NfG CPMP/BWP/214/96.
To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2010-2011 formulation.

Detailed Description

Each participant will receive a dose of their assigned vaccine on Day 0 and will be followed up for 21 days post-vaccination.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Group 1

Experimental

Participants at 18 to 59 years of age

Intervention: Influenza virus vaccine (split virion, inactivated) (Biological)

Group 2

Experimental

Participants at 60 years of age or older

Intervention: Influenza virus vaccine (split virion, inactivated) (Biological)

Outcomes

Primary Outcomes

Information concerning the safety (solicited and unsolicited adverse events) of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

Time Frame: 21 days post-vaccination

Information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

Time Frame: 21 days post-vaccination

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (2)

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