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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Seasonal Influenza Vaccine

• Registration Number: NCT01357265
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-05
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Study Completion: 2011-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Seasonal Influenza Vaccine	No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Primary Outcome Measures

Name	Time	Method
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly	22 days including follow-up period	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.

Trial Locations

Locations (6)

Dipartimento di malattie infettive Ospedale San Gerardo; 🇮🇹 Via Pergolesi 33, Monza, Italy

Distretto Sanitario di Base di Fossacesia; 🇮🇹 Via Polidoro-Vasto, Lanciano, Italy

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

ASL Lanciano - Vasto,; 🇮🇹 Via S. Spaventa, Lanciano, Italy

Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute; 🇮🇹 Via Stamira d'Ancona, Milano, Italy