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

Novartis Vaccines125 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

125

Conditions

Influenza

Interventions

Seasonal Influenza VaccineBIOLOGICAL

This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio

Via Dei Vestini, Cheiti, Italy

Dipartimento di Scienze della Salute Università di Genova

Via Pastore, Genova, Italy

Distretto Sanitario di Base di Fossacesia

Via Polidoro-Vasto, Lanciano, Italy

ASL Lanciano - Vasto,

Via S. Spaventa, Lanciano, Italy

Outcomes

Primary Outcomes

To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly

To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Time frame: 22 days including follow-up period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.