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

Primary Purpose

Influenza, Human

Status
Completed
Phase
Phase 3
Locations
Germany
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 medical conditions, Underlying cardiovascular medical condition, Pandemic vaccine, Charlson Comorbidity Index (CCI), 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 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.

Sites / Locations

  • 001, Novartis Investigational Site
  • 003, Novartis Investigational Site
  • 005, Novartis Investigational Site
  • 006, Novartis Investigational Site
  • 004, Novartis Investigational Site
  • 002, 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 3: aTIV adult

Arm 4: aTIV elderly

Arm Description

aH5N1 healthy and non-healthy adults

aH5N1 healthy and non-healthy elderly

aTIV healthy and non-healthy adults

aTIV healthy and non-healthy elderly

Outcomes

Primary Outcome Measures

Percentage of subjects achieving seroconversion
Seroconversion is defined as hemagglutination inhibition (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])
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 (GMTs) as determined by HI
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Geometric mean ratios (GMRs) as determined by SRH
Percentage of subjects with an HI titer ≥1:40
Percentage of subjects achieving seroconversion
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])
Percentage of subjects with geometric mean area ≥25 mm2
Percentage of subjects achieving seroconversion
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])
GMTs as determined by SRH
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
GMRs as determined by HI
Geometric mean titers (GMTs) as determined by HI
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Geometric mean titers (GMTs) as determined by HI
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
GMRs as determined by SRH
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 achieving seroconversion
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])
GMTs as determined by SRH
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Geometric mean ratios (GMRs) as determined by SRH

Full Information

First Posted
March 7, 2014
Last Updated
November 3, 2016
Sponsor
Seqirus
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT02091908
Brief Title
Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions
Official Title
Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 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 underlying medical conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
540 (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 3: aTIV adult
Arm Type
Active Comparator
Arm Description
aTIV healthy and non-healthy adults
Arm Title
Arm 4: aTIV elderly
Arm Type
Active Comparator
Arm Description
aTIV healthy and non-healthy elderly
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 is defined as hemagglutination inhibition (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])
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 (GMTs) as determined by HI
Description
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Time Frame
day 1
Title
Geometric mean ratios (GMRs) as determined by SRH
Time Frame
day 22
Title
Percentage of subjects with an HI titer ≥1:40
Time Frame
day 22
Title
Percentage of subjects achieving seroconversion
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])
Time Frame
day 22
Title
Percentage of subjects with geometric mean area ≥25 mm2
Time Frame
day 43
Title
Percentage of subjects achieving seroconversion
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])
Time Frame
day 22
Title
GMTs as determined by SRH
Description
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Time Frame
day 43 (3 weeks after the second vaccination)
Title
GMRs as determined by HI
Time Frame
day 22
Title
Geometric mean titers (GMTs) as determined by HI
Description
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Time Frame
day 43 (3 weeks after the second vaccination)
Title
Geometric mean titers (GMTs) as determined by HI
Description
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Time Frame
day 22 (3 weeks after the first vaccination)
Title
GMRs as determined by SRH
Time Frame
day 43
Title
Percentage of subjects with an HI titer ≥1:40
Time Frame
day 1
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 achieving seroconversion
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])
Time Frame
day 43
Title
GMTs as determined by SRH
Description
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
Time Frame
day 1
Title
Geometric mean ratios (GMRs) as determined by SRH
Time Frame
day 43 (3 weeks after the second vaccination)

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 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.
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
001, Novartis Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
003, Novartis Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
005, Novartis Investigational Site
City
Hamburg
ZIP/Postal Code
20359
Country
Germany
Facility Name
006, Novartis Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
004, Novartis Investigational Site
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Facility Name
002, Novartis Investigational Site
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Citations:
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
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

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

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