Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

November 30, 2016 updated by: Novartis Vaccines

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

  • Any serious disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Fluvirin
Biological: Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the antibody response to each influenza vaccine antigen
Time Frame: 21 days post-immunization
21 days post-immunization

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of the study vaccine in the study population
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V78P5S
  • 2007-002063-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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