NCT02107807

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

March 7, 2014

Last Update Submit

May 5, 2016

Conditions

Influenza, HumanFlu, HumanFlu, AvianInfluenzaInfluenza A Virus, H5N1 Subtype

Keywords

Influenza,H5N1aH5N1H5N1 vaccinePandemic Influenza vaccineMF59AdjuvantAvian fluUnderlying Immunosuppressiveimmunosuppressive conditionsPandemic vaccineAdjuvanted vaccine

Outcome Measures

Primary Outcomes (4)

  • Percentage of subjects achieving seroconversion*

    \*seroconversion: (defined as HI ≥1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer ≥1:10\]) on day 43.

    day 43

  • Geometric mean ratios (GMRs) as determined by HI assay

    day 43

  • Percentage of subjects with an HI titer ≥1:40

    day 43

  • Solicited and unsolicited adverse events

    In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.

    day 202

Secondary Outcomes (18)

  • Geometric mean titers as determined by Hemagglutination Inhibition

    Day 1

  • Geometric mean titers as determined by Hemagglutination Inhibition

    Day 22

  • Geometric mean titers as determined by Hemagglutination Inhibition

    Day 43

  • Geometric mean titers as determined by Single Radial Hemolysis

    Day 1

  • Geometric mean titers as determined by Single Radial Hemolysis

    Day 22

  • +13 more secondary outcomes

Study Arms (4)

Arm 1: aH5N1 adult

EXPERIMENTAL

aH5N1 healthy and non-healthy adults

Biological: Novartis Investigational H5N1 vaccine

Arm 2: aH5N1 elderly

EXPERIMENTAL

aH5N1 healthy and non-healthy elderly

Biological: Novartis Investigational H5N1 vaccine

Arm 4: aTIV elderly

ACTIVE COMPARATOR

aTIV healthy and non-healthy elderly

Biological: Novartis Seasonal Influenza Vaccine

Arm 3: aTIV adult

ACTIVE COMPARATOR

aTIV healthy and non-healthy adults

Biological: Novartis Seasonal Influenza Vaccine

Interventions

Novartis Investigational H5N1 vaccineBIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 1: aH5N1 adult
Novartis Seasonal Influenza VaccineBIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 4: aTIV elderly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

102, Novartis Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

103, Novartis Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

101, Novartis Investigational Site

Merewether, New South Wales, 2291, Australia

Location

303, Novartis Investiagtional Site

Würzburg, Bavaria, 97070, Germany

Location

302, Novartis Investigational Site

Hamburg, Hamburg, 39120, Germany

Location

304, Novartis Investigational Site

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

301, Novartis Investigational Site

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

005, Novartis Investigational Site

Chieti, Chieti, 66013, Italy

Location

008, Novartis Investigational Site

Chieti, Chieti, 66013, Italy

Location

082, Novartis Investigational Site

Fossacesia, Chieti, 66022, Italy

Location

081, Novartis Investigational Site

Lanciano, Chieti, 66034, Italy

Location

003, Novartis Investigational Site

Monza, Milan, 20052, Italy

Location

007, Novartis Investigational Site

Aviano, Padova, 33080, Italy

Location

004, Novartis Investigational Site

Parma, Parma, 43100, Italy

Location

006, Novartis Investigational Site

San Daniele del Friuli, Udine, 33038, Italy

Location

001, Novartis Investigational Site

Milan, 20127, Italy

Location

002, Novartis Investigational Site

Milan, 20157, Italy

Location

Related Publications (3)

  • 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.

    PMID: 11257408BACKGROUND

  • 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.

    PMID: 17029131BACKGROUND

  • 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.

    PMID: 19197383BACKGROUND

MeSH Terms

Conditions

Influenza, HumanInfluenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBird DiseasesAnimal Diseases

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

April 8, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations

DE(4)AU(3)IT(10)