Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

NCT00620815 | Completed Phase 2 Results

• 2 other identifiers: V101P12007-002712-25
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)

Conditions

Influenza

Keywords

avian flu; seasonal influenza vaccine; influenza vaccine; prepandemic vaccine; virus strain with the potential to cause pandemic; tetravalent vaccine; Prophylaxis of influenza

Outcome Measures

Primary Outcomes (1)

• To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.

  The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence. The statistical analysis was done based on the GMRs.

  up to day 43

Secondary Outcomes (8)

• Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination

  Up to 7 days after 1st vaccination

• Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination

  Up to 7 days after 2nd vaccination

• Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.

  7 days after 1st and 2nd vaccinations each

• Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain

  up to day 43

• Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2

  Up to 43 days

Study Arms (6)

T/P-A

EXPERIMENTAL

One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22

Biological: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine

A/P-T

EXPERIMENTAL

One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22.

Biological: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1

A/S-A

ACTIVE COMPARATOR

One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22.

Biological: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine

T/P-A (V2 blood draw)

EXPERIMENTAL

One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.

Biological: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine

A/P-T (V2 blood draw)

EXPERIMENTAL

One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22.

Biological: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1

A/S-A (V2 blood draw)

ACTIVE COMPARATOR

One dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.

Biological: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine

Interventions

MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine BIOLOGICAL

Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.

T/P-A

Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1 BIOLOGICAL

Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.

A/P-T (V2 blood draw)

Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine BIOLOGICAL

Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

A/S-A (V2 blood draw)

MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine BIOLOGICAL

Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

T/P-A (V2 blood draw)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects (aged 18 years and above) who have signed an informed consent form

You may not qualify if:

• Any acute or chronic illness
• Receipt of seasonal influenza vaccine for the current season 2007/2008
• Known or suspected impairment/alteration of immune function
• Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
• Any serious disease
• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
• Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

ATRIUM Gesundheitszentrum;

Holzkirchen, 83607, Germany

Location

International Medicine & Public Health Dept. of Infect. Diseases

Munich, 80799, Germany

Location

Related Publications (1)

• Herbinger KH, von Sonnenburg F, Nothdurft HD, Perona P, Borkowski A, Fragapane E, Nicolay U, Clemens R. A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59(R): adjuvanted, pre-pandemic, A/H5N1 vaccine and trivalent seasonal influenza vaccine in healthy adults. Hum Vaccin Immunother. 2014;10(1):92-9. doi: 10.4161/hv.26495. Epub 2013 Sep 20.

  PMID: 24047817 DERIVED

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

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 28, 2016
• Results First Posted: September 19, 2012

Record last verified: 2016-03

Locations

DE (2)