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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

NCT ID: NCT00848848

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine

2

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + high A

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine with high A content

3

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + ¼ dose adjuvant

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

4

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

Intervention Type BIOLOGICAL

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

5

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + ½ dose adjuvant

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

6

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

Intervention Type BIOLOGICAL

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

7

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + adjuvant

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine plus adjuvant

8

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + high A + adjuvant

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

9

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine intradermal dose

Intervention Type BIOLOGICAL

1 dose of Trivalent Influenza Vaccine intradermal dose

10

Group Type ACTIVE_COMPARATOR

Trivalent Influenza Vaccine + high A intradermal dose

Intervention Type BIOLOGICAL

1 intradermal dose of Trivalent Influenza Vaccine + high A

Interventions

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Trivalent Influenza Vaccine

1 dose of Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + high A

1 dose of Trivalent Influenza Vaccine with high A content

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

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

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

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

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + adjuvant

1 dose of Trivalent Influenza Vaccine plus adjuvant

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + high A + adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine intradermal dose

1 dose of Trivalent Influenza Vaccine intradermal dose

Intervention Type BIOLOGICAL

Trivalent Influenza Vaccine + high A intradermal dose

1 intradermal dose of Trivalent Influenza Vaccine + high A

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Center For Vaccinology

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24732325 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22426371 (View on PubMed)

Other Identifiers

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2008-002625-36

Identifier Type: -

Identifier Source: secondary_id

V104P3

Identifier Type: -

Identifier Source: org_study_id

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