Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

NCT ID: NCT02107807

Last Updated: 2016-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-05-31

Brief Summary

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 immunosuppressive conditions.

Conditions

Influenza, Human; Flu, Human; Flu, Avian; Influenza; Influenza A Virus, H5N1 Subtype

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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 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

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

Interventions

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

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 HIV positive, transplant recipients, cancer patients 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

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Seqirus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

102, Novartis Investigational Site

Darlinghurst, New South Wales, Australia

103, Novartis Investigational Site

Darlinghurst, New South Wales, Australia

101, Novartis Investigational Site

Merewether, New South Wales, Australia

303, Novartis Investiagtional Site

Würzburg, Bavaria, Germany

302, Novartis Investigational Site

Hamburg, City state of Hamburg, Germany

304, Novartis Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

301, Novartis Investigational Site

Magdeburg, Saxony-Anhalt, Germany

005, Novartis Investigational Site

Chieti, Chieti, Italy

008, Novartis Investigational Site

Chieti, Chieti, Italy

082, Novartis Investigational Site

Fossacesia, Chieti, Italy

081, Novartis Investigational Site

Lanciano, Chieti, Italy

003, Novartis Investigational Site

Monza, Milan, Italy

007, Novartis Investigational Site

Aviano, Padova, Italy

004, Novartis Investigational Site

Parma, Parma, Italy

006, Novartis Investigational Site

San Daniele del Friuli, Udine, Italy

001, Novartis Investigational Site

Milan, , Italy

002, Novartis Investigational Site

Milan, , Italy

Countries

Australia; Germany; Italy

References

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)

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)

Other Identifiers

2011-003573-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V87_26

Identifier Type: -

Identifier Source: org_study_id