Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

May 5, 2016 updated by: Seqirus

A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 1

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

  • Belgium
      • Ghent, Belgium, 9000
        • Center for Vaccinology

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

  • Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
  • Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Biological: Trivalent Influenza Vaccine + high A
1 dose of Trivalent Influenza Vaccine with high A content
Active Comparator: 1
Biological: Trivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine
Active Comparator: 3
Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
Active Comparator: 4
Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
Active Comparator: 5
Biological: Trivalent Influenza Vaccine + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
Active Comparator: 7
Biological: Trivalent Influenza Vaccine + adjuvant
1 dose of Trivalent Influenza Vaccine plus adjuvant
Active Comparator: 8
Biological: Trivalent Influenza Vaccine + high A + adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
Active Comparator: 6
Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
Active Comparator: 9
Biological: Trivalent Influenza Vaccine intradermal dose
1 dose of Trivalent Influenza Vaccine intradermal dose
Active Comparator: 10
Biological: Trivalent Influenza Vaccine + high A intradermal dose
1 intradermal dose of Trivalent Influenza Vaccine + high A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Time Frame: 21 days
21 days

Collaborators and Investigators

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

Sponsor

Seqirus

Collaborators

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V104P3
  • 2008-002625-36

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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