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

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1; Biological: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine; Biological: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine; Biological: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine; Biological: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine; Biological: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620815

2007-002712-25

V101P1

Details and patient eligibility

About

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

Enrollment: 601 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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601 participants in 6 patient groups

T/P-A

Experimental group

Description:

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

Treatment:

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

A/P-T

Experimental group

Description:

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.

Treatment:

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

A/S-A

Active Comparator group

Description:

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.

Treatment:

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

T/P-A (V2 blood draw)

Experimental group

Description:

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.

Treatment:

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

A/P-T (V2 blood draw)

Experimental group

Description:

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.

Treatment:

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

A/S-A (V2 blood draw)

Active Comparator group

Description:

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.

Treatment:

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