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Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

NCT ID: NCT00481065

Last Updated: 2014-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

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This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

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Detailed Description

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Conditions

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Pandemic Avian Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Concomitant alone

1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382.

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Concomitant +Mixed

1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Concomitant +MF59-eH5N1

1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Mixed

1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Mixed and mixed

1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Mixed+MF59-eH5N1

1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1+eTIV_a

1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

eTIV_a+MF59-eH5N1

1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382

Group Type EXPERIMENTAL

MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Interventions

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MF59-eH5N1

Intervention Type BIOLOGICAL

eTIV_a

Intervention Type BIOLOGICAL

MF59-eH5N1 + eTIV_a

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Drug Information Services +1 800 244 7668

Role: STUDY_CHAIR

Novartis

Locations

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Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.

Reference Type RESULT
PMID: 21606530 (View on PubMed)

Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.

Reference Type DERIVED
PMID: 23536690 (View on PubMed)

Other Identifiers

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V87P5

Identifier Type: -

Identifier Source: org_study_id

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