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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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Trivalent Influenza Vaccine

Trivalent Influenza Vaccine + high A

Trivalent Influenza Vaccine + ¼ dose adjuvant

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

Trivalent Influenza Vaccine + ½ dose adjuvant

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

Trivalent Influenza Vaccine + adjuvant

Trivalent Influenza Vaccine + high A + adjuvant

Trivalent Influenza Vaccine intradermal dose

Trivalent Influenza Vaccine + high A intradermal dose

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Flu, Vaccine, Intradermal, Adjuvant

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Center For Vaccinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.

Secondary Outcome Measures

Strain-specific influenza antibody titers will be used to assess Immunogenicity

Full Information

NCT ID

NCT00848848

First Posted

February 19, 2009

Last Updated

May 5, 2016

Sponsor

Seqirus

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00848848

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seqirus

Collaborators

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Flu, Vaccine, Intradermal, Adjuvant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine

Intervention Description

1 dose of Trivalent Influenza Vaccine

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + high A

Intervention Description

1 dose of Trivalent Influenza Vaccine with high A content

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + ¼ dose adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + ½ dose adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine plus adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + high A + adjuvant

Intervention Description

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine intradermal dose

Intervention Description

1 dose of Trivalent Influenza Vaccine intradermal dose

Intervention Type

Biological

Intervention Name(s)

Trivalent Influenza Vaccine + high A intradermal dose

Intervention Description

1 intradermal dose of Trivalent Influenza Vaccine + high A

Primary Outcome Measure Information:

Title

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Strain-specific influenza antibody titers will be used to assess Immunogenicity

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

Center For Vaccinology

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

24732325

Citation

Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14.

Results Reference

derived

PubMed Identifier

22426371

Citation

Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.

Results Reference

derived

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