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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107807
• Other study ID #: V87_26
• Secondary ID: 2011-003573-28
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2014
• Last updated: May 5, 2016
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyAustralia: Therapeutic Goods AdministrationGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical 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 immunosuppressive conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart
• Novartis Investigational H5N1 vaccine
2 doses of 0.5 ml, 3 weeks apart
• Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart
• Novartis Seasonal Influenza Vaccine
2 doses of 0.5 ml, 3 weeks apart

Locations

Country	Name	City	State
Australia	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
Germany	302, Novartis Investigational Site	Hamburg
Germany	301, Novartis Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	304, Novartis Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	303, Novartis Investiagtional Site	Würzburg	Bayern
Italy	007, Novartis Investigational Site	Aviano	Padova
Italy	005, Novartis Investigational Site	Chieti
Italy	008, Novartis Investigational Site	Chieti
Italy	082, Novartis Investigational Site	Fossacesia	Chieti
Italy	081, Novartis Investigational Site	Lanciano	Chieti
Italy	001, Novartis Investigational Site	Milan
Italy	002, Novartis Investigational Site	Milan
Italy	003, Novartis Investigational Site	Monza	Milan
Italy	004, Novartis Investigational Site	Parma
Italy	006, Novartis Investigational Site	San Daniele del Friuli	Udine

Sponsors (2)

Lead Sponsor	Collaborator
Seqirus	Novartis Vaccines

Countries where clinical trial is conducted

Australia,  Germany,  Italy, 

References & Publications (3)

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. Epub 2006 Sep 25. — View 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]. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Geometric mean ratios (GMRs) as determined by HI assay		day 43	No
Primary	Percentage of subjects with an HI titer =1:40		day 43	No
Primary	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	Yes
Secondary	Geometric mean titers as determined by Hemagglutination Inhibition		Day 1	No
Secondary	Geometric mean titers as determined by Hemagglutination Inhibition		Day 22	No
Secondary	Geometric mean titers as determined by Hemagglutination Inhibition		Day 43	No
Secondary	Geometric mean titers as determined by Single Radial Hemolysis		Day 1	No
Secondary	Geometric mean titers as determined by Single Radial Hemolysis		Day 22	No
Secondary	Geometric mean titers as determined by Single Radial Hemolysis		Day 43	No
Secondary	Geometric Mean Ratio as determined by Hemagglutination Inhibition		Day 22	No
Secondary	Geometric Mean Ratio as determined by Hemagglutination Inhibition		Day 43	No
Secondary	Geometric Mean Ratio as determined by Single Radial Hemolysis		Day 22	No
Secondary	Geometric Mean Ratio as determined by Single Radial Hemolysis		Day 43	No
Secondary	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	Day 22	No
Secondary	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	Day 22	No
Secondary	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	Day 43	No
Secondary	Percentage of subjects with an HI titer =1:40		Day 1	No
Secondary	Percentage of subjects with an HI titer =1:40		Day 22	No
Secondary	Percentage of subjects with geometric mean area =25 mm2		Day 1	No
Secondary	Percentage of subjects with geometric mean area =25 mm2		Day 22	No
Secondary	Percentage of subjects with geometric mean area =25 mm2		Day 43	No