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Influenza, HumanPhase 3NCT02091908

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

A Phase 3 study testing Novartis Investigational H5N1 vaccine and Novartis Seasonal Influenza Vaccine in people with Influenza, Human, run by Seqirus at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
Novartis Investigational H5N1 vaccine and Novartis Seasonal Influenza Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
6 sitesGermany
Study dates
Apr 2014to Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • 001, Novartis Investigational Site

    Berlin, 10117

  • 003, Novartis Investigational Site

    Dresden, 01307

  • 005, Novartis Investigational Site

    Hamburg, 20359

  • 006, Novartis Investigational Site

    Magdeburg, 39120

  • 004, Novartis Investigational Site

    Rostock, 18055

  • 002, Novartis Investigational Site

    Würzburg, 97070

Other trials in Germany

About this study

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.

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.

Being tested
Novartis Investigational H5N1 vaccine, Novartis Seasonal Influenza Vaccine
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
Medical subject headings
Influenza, Human, Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novartis Investigational H5N1 vaccineBiological

    2 doses of 0.5 ml, 3 weeks apart

  • Novartis Investigational H5N1 vaccineBiological

    2 doses of 0.5 ml, 3 weeks apart

  • Novartis Seasonal Influenza VaccineBiological

    2 doses of 0.5 ml, 3 weeks apart

  • Novartis Seasonal Influenza VaccineBiological

    2 doses of 0.5 ml, 3 weeks apart

Study groups in NCT02091908
Study groupRoleWhat they receive
Arm 1: aH5N1 adultExperimentalaH5N1 healthy and non-healthy adults
Receives: Biological: Novartis Investigational H5N1 vaccine
Arm 2: aH5N1 elderlyExperimentalaH5N1 healthy and non-healthy elderly
Receives: Biological: Novartis Investigational H5N1 vaccine
Arm 3: aTIV adultActive comparatoraTIV healthy and non-healthy adults
Receives: Biological: Novartis Seasonal Influenza Vaccine
Arm 4: aTIV elderlyActive comparatoraTIV healthy and non-healthy elderly
Receives: Biological: Novartis Seasonal Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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])

    Measured: day 43

  2. Geometric mean ratios (GMRs) as determined by HI assay

    Measured: day 43

  3. Percentage of subjects with an HI titer ≥1:40

    Measured: day 43

  4. 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.

    Measured: day 202

Secondary outcomes (17)

  1. 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

    Measured: day 1

  2. Geometric mean ratios (GMRs) as determined by SRH

    Measured: day 22

  3. Percentage of subjects with an HI titer ≥1:40

    Measured: day 22

  4. 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])

    Measured: day 22

  5. Percentage of subjects with geometric mean area ≥25 mm2

    Measured: day 43

  6. 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])

    Measured: day 22

  7. 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

    Measured: day 43 (3 weeks after the second vaccination)

  8. GMRs as determined by HI

    Measured: day 22

  9. 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

    Measured: day 43 (3 weeks after the second vaccination)

  10. 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

    Measured: day 22 (3 weeks after the first vaccination)

  11. GMRs as determined by SRH

    Measured: day 43

  12. Percentage of subjects with an HI titer ≥1:40

    Measured: day 1

  13. Percentage of subjects with geometric mean area ≥25 mm2

    Measured: day 1

  14. Percentage of subjects with geometric mean area ≥25 mm2

    Measured: day 22

  15. 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])

    Measured: day 43

  16. 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

    Measured: day 1

  17. Geometric mean ratios (GMRs) as determined by SRH

    Measured: day 43 (3 weeks after the second vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02091908
Sponsor's protocol ID
V87_25
Status last verified
Nov 2016
First submitted
7 Mar 2014
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17029131

  • 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.

    PubMed 19197383

  • 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.

    PubMed 11257408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Novartis Investigational H5N1 vaccine and Novartis Seasonal Influenza Vaccine in people with Influenza, Human, run by Seqirus at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects achieving seroconversion (time frame: day 43). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02091908, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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