Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Seasonal Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357265

2010-024400-98 (EudraCT Number)

V71_27S

Details and patient eligibility

About

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy, adult and elderly volunteers over 18 years

Exclusion criteria

Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

1

Other group

Description:

No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Treatment:

Biological: Seasonal Influenza Vaccine