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NCT02091908

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions

NCT ID: NCT02091908

Last Updated: 2016-11-04

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

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.

Detailed Description

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Conditions

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Influenza, Human

Keywords

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Influenza H5N1 aH5N1 H5N1 vaccine Pandemic Influenza vaccine MF59, Adjuvant, Avian flu Underlying medical conditions Underlying cardiovascular medical condition Pandemic vaccine Charlson Comorbidity Index (CCI) Adjuvanted vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1: aH5N1 adult

aH5N1 healthy and non-healthy adults

Group Type EXPERIMENTAL

Novartis Investigational H5N1 vaccine

Intervention Type BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 2: aH5N1 elderly

aH5N1 healthy and non-healthy elderly

Group Type EXPERIMENTAL

Novartis Investigational H5N1 vaccine

Intervention Type BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 3: aTIV adult

aTIV healthy and non-healthy adults

Group Type ACTIVE_COMPARATOR

Novartis Seasonal Influenza Vaccine

Intervention Type BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 4: aTIV elderly

aTIV healthy and non-healthy elderly

Group Type ACTIVE_COMPARATOR

Novartis Seasonal Influenza Vaccine

Intervention Type BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Interventions

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Novartis Investigational H5N1 vaccine

2 doses of 0.5 ml, 3 weeks apart

Intervention Type BIOLOGICAL

Novartis Investigational H5N1 vaccine

2 doses of 0.5 ml, 3 weeks apart

Intervention Type BIOLOGICAL

Novartis Seasonal Influenza Vaccine

2 doses of 0.5 ml, 3 weeks apart

Intervention Type BIOLOGICAL

Novartis Seasonal Influenza Vaccine

2 doses of 0.5 ml, 3 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* \- Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
* Individuals who are able to comply with all study procedures and requirements;
* Healthy volunteers and volunteers specifically with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible;
* Please contact the site for additional eligibility criteria.

Exclusion Criteria

* Individuals who are not able to follow all the required study procedures for the whole period of the study;
* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
* Please contact the site for additional eligibility criteria.

Minimum Eligible Age

18 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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001, Novartis Investigational Site

Berlin, , Germany

Site Status

003, Novartis Investigational Site

Dresden, , Germany

Site Status

005, Novartis Investigational Site

Hamburg, , Germany

Site Status

006, Novartis Investigational Site

Magdeburg, , Germany

Site Status

004, Novartis Investigational Site

Rostock, , Germany

Site Status

002, Novartis Investigational Site

Würzburg, , Germany

Site Status

Countries

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Germany

References

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Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 25.

Reference Type BACKGROUND

PMID: 17029131 (View on PubMed)

Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6.

Reference Type BACKGROUND

PMID: 19197383 (View on PubMed)

Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80. doi: 10.1016/s0264-410x(00)00499-0.

Reference Type BACKGROUND

PMID: 11257408 (View on PubMed)

Other Identifiers

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V87_25

Identifier Type: -

Identifier Source: org_study_id