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

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

Completed

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via Dei Vestini, Cheiti, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seasonal Influenza Vaccine

Biological

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) .

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 20, 2011
Registry last updated: Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed