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

Primary Purpose

Influenza, Human, Flu, Human, Flu, Avian

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Novartis Investigational H5N1 vaccine
Novartis Investigational H5N1 vaccine
Novartis Seasonal Influenza Vaccine
Novartis Seasonal Influenza Vaccine
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza,, H5N1, aH5N1, H5N1 vaccine, Pandemic Influenza vaccine, MF59, Adjuvant, Avian flu, Underlying Immunosuppressive, immunosuppressive conditions, Pandemic vaccine, Adjuvanted vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 102, Novartis Investigational Site
  • 103, Novartis Investigational Site
  • 101, Novartis Investigational Site
  • 303, Novartis Investiagtional Site
  • 304, Novartis Investigational Site
  • 301, Novartis Investigational Site
  • 302, Novartis Investigational Site
  • 082, Novartis Investigational Site
  • 081, Novartis Investigational Site
  • 003, Novartis Investigational Site
  • 007, Novartis Investigational Site
  • 006, Novartis Investigational Site
  • 005, Novartis Investigational Site
  • 008, Novartis Investigational Site
  • 001, Novartis Investigational Site
  • 002, Novartis Investigational Site
  • 004, Novartis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Arm 1: aH5N1 adult

Arm 2: aH5N1 elderly

Arm 4: aTIV elderly

Arm 3: aTIV adult

Arm Description

aH5N1 healthy and non-healthy adults

aH5N1 healthy and non-healthy elderly

aTIV healthy and non-healthy elderly

aTIV healthy and non-healthy adults

Outcomes

Primary Outcome Measures

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.
Geometric mean ratios (GMRs) as determined by HI assay
Percentage of subjects with an HI titer ≥1:40
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.

Secondary Outcome Measures

Geometric mean titers as determined by Hemagglutination Inhibition
Geometric mean titers as determined by Hemagglutination Inhibition
Geometric mean titers as determined by Hemagglutination Inhibition
Geometric mean titers as determined by Single Radial Hemolysis
Geometric mean titers as determined by Single Radial Hemolysis
Geometric mean titers as determined by Single Radial Hemolysis
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Geometric Mean Ratio as determined by Single Radial Hemolysis
Geometric Mean Ratio as determined by Single Radial Hemolysis
Percentage of subjects achieving seroconversion determined by HI
seroconversion is 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 days 22
Percentage of subjects achieving seroconversion determined by SRH
seroconversion (defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43
Percentage of subjects achieving seroconversion determined by SRH
seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43
Percentage of subjects with an HI titer ≥1:40
Percentage of subjects with an HI titer ≥1:40
Percentage of subjects with geometric mean area ≥25 mm2
Percentage of subjects with geometric mean area ≥25 mm2
Percentage of subjects with geometric mean area ≥25 mm2

Full Information

First Posted
March 7, 2014
Last Updated
May 5, 2016
Sponsor
Seqirus
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT02107807
Brief Title
Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine
Official Title
A Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1when Administered to Adult and Elderly Subjects With and Without Immunosuppressive Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
Collaborators
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Flu, Human, Flu, Avian, Influenza, Influenza A Virus, H5N1 Subtype
Keywords
Influenza,, H5N1, aH5N1, H5N1 vaccine, Pandemic Influenza vaccine, MF59, Adjuvant, Avian flu, Underlying Immunosuppressive, immunosuppressive conditions, Pandemic vaccine, Adjuvanted vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
539 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: aH5N1 adult
Arm Type
Experimental
Arm Description
aH5N1 healthy and non-healthy adults
Arm Title
Arm 2: aH5N1 elderly
Arm Type
Experimental
Arm Description
aH5N1 healthy and non-healthy elderly
Arm Title
Arm 4: aTIV elderly
Arm Type
Active Comparator
Arm Description
aTIV healthy and non-healthy elderly
Arm Title
Arm 3: aTIV adult
Arm Type
Active Comparator
Arm Description
aTIV healthy and non-healthy adults
Intervention Type
Biological
Intervention Name(s)
Novartis Investigational H5N1 vaccine
Intervention Description
2 doses of 0.5 ml, 3 weeks apart
Intervention Type
Biological
Intervention Name(s)
Novartis Investigational H5N1 vaccine
Intervention Description
2 doses of 0.5 ml, 3 weeks apart
Intervention Type
Biological
Intervention Name(s)
Novartis Seasonal Influenza Vaccine
Intervention Description
2 doses of 0.5 ml, 3 weeks apart
Intervention Type
Biological
Intervention Name(s)
Novartis Seasonal Influenza Vaccine
Intervention Description
2 doses of 0.5 ml, 3 weeks apart
Primary Outcome Measure Information:
Title
Percentage of subjects achieving seroconversion*
Description
*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.
Time Frame
day 43
Title
Geometric mean ratios (GMRs) as determined by HI assay
Time Frame
day 43
Title
Percentage of subjects with an HI titer ≥1:40
Time Frame
day 43
Title
Solicited and unsolicited adverse events
Description
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.
Time Frame
day 202
Secondary Outcome Measure Information:
Title
Geometric mean titers as determined by Hemagglutination Inhibition
Time Frame
Day 1
Title
Geometric mean titers as determined by Hemagglutination Inhibition
Time Frame
Day 22
Title
Geometric mean titers as determined by Hemagglutination Inhibition
Time Frame
Day 43
Title
Geometric mean titers as determined by Single Radial Hemolysis
Time Frame
Day 1
Title
Geometric mean titers as determined by Single Radial Hemolysis
Time Frame
Day 22
Title
Geometric mean titers as determined by Single Radial Hemolysis
Time Frame
Day 43
Title
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Time Frame
Day 22
Title
Geometric Mean Ratio as determined by Hemagglutination Inhibition
Time Frame
Day 43
Title
Geometric Mean Ratio as determined by Single Radial Hemolysis
Time Frame
Day 22
Title
Geometric Mean Ratio as determined by Single Radial Hemolysis
Time Frame
Day 43
Title
Percentage of subjects achieving seroconversion determined by HI
Description
seroconversion is 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 days 22
Time Frame
Day 22
Title
Percentage of subjects achieving seroconversion determined by SRH
Description
seroconversion (defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43
Time Frame
Day 22
Title
Percentage of subjects achieving seroconversion determined by SRH
Description
seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43
Time Frame
Day 43
Title
Percentage of subjects with an HI titer ≥1:40
Time Frame
Day 1
Title
Percentage of subjects with an HI titer ≥1:40
Time Frame
Day 22
Title
Percentage of subjects with geometric mean area ≥25 mm2
Time Frame
Day 1
Title
Percentage of subjects with geometric mean area ≥25 mm2
Time Frame
Day 22
Title
Percentage of subjects with geometric mean area ≥25 mm2
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
102, Novartis Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
103, Novartis Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
101, Novartis Investigational Site
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
303, Novartis Investiagtional Site
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
304, Novartis Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
Facility Name
301, Novartis Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
302, Novartis Investigational Site
City
Hamburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
082, Novartis Investigational Site
City
Fossacesia
State/Province
Chieti
ZIP/Postal Code
66022
Country
Italy
Facility Name
081, Novartis Investigational Site
City
Lanciano
State/Province
Chieti
ZIP/Postal Code
66034
Country
Italy
Facility Name
003, Novartis Investigational Site
City
Monza
State/Province
Milan
ZIP/Postal Code
20052
Country
Italy
Facility Name
007, Novartis Investigational Site
City
Aviano
State/Province
Padova
ZIP/Postal Code
33080
Country
Italy
Facility Name
006, Novartis Investigational Site
City
San Daniele del Friuli
State/Province
Udine
ZIP/Postal Code
33038
Country
Italy
Facility Name
005, Novartis Investigational Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
008, Novartis Investigational Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
001, Novartis Investigational Site
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
002, Novartis Investigational Site
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
004, Novartis Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
11257408
Citation
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.
Results Reference
background
PubMed Identifier
17029131
Citation
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.
Results Reference
background
PubMed Identifier
19197383
Citation
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. Erratum In: PLoS ONE. 2009;4(3). doi: 10.1371/annotation/5f2ae0fb-53f1-48c2-aa19-9114765ba029. Capecchi, Pamela [corrected to Capecchi, Pier Leopoldo].
Results Reference
background

Learn more about this trial

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

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