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

NCT02091908 | Completed Phase 3

• 1 other identifier: V87_25
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 \[day 1 HI titer ≥1:10\])

  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 (17)

• Geometric mean titers (GMTs) as determined by HI

  day 1

• Geometric mean ratios (GMRs) as determined by SRH

  day 22

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

  day 22

• Percentage of subjects achieving seroconversion

  day 22

• Percentage of subjects with geometric mean area ≥25 mm2

  day 43

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 3: aTIV adult

ACTIVE COMPARATOR

aTIV healthy and non-healthy adults

Biological: Novartis Seasonal Influenza Vaccine

Arm 4: aTIV elderly

ACTIVE COMPARATOR

aTIV healthy and non-healthy elderly

Biological: Novartis Seasonal Influenza Vaccine

Interventions

Novartis Investigational H5N1 vaccine BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 1: aH5N1 adult

Novartis Seasonal Influenza Vaccine BIOLOGICAL

2 doses of 0.5 ml, 3 weeks apart

Arm 3: aTIV adult

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment 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.

Sponsors & Collaborators

• Seqirus: lead
• Novartis Vaccines: collaborator

Study Sites (6)

001, Novartis Investigational Site

Berlin, 10117, Germany

Location

003, Novartis Investigational Site

Dresden, 01307, Germany

Location

005, Novartis Investigational Site

Hamburg, 20359, Germany

Location

006, Novartis Investigational Site

Magdeburg, 39120, Germany

Location

004, Novartis Investigational Site

Rostock, 18055, Germany

Location

002, Novartis Investigational Site

Würzburg, 97070, Germany

Location

Related 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. doi: 10.1086/508174. Epub 2006 Sep 25.

  PMID: 17029131 BACKGROUND

• 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: 19197383 BACKGROUND

• 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: 11257408 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal 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: March 19, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

DE (6)