Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza

Treatments: Biological: MF59-eH1N1_f

Study type: Interventional

Funder types: Industry

Identifiers

NCT00973349

V112_01

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Enrollment: 2,719 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion criteria

• History of serious disease.
• History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
• Known or suspected impairment/alteration of immune function.
• Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
• Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
• For additional entry criteria, please refer to protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,719 participants in 8 patient groups

3.75_(50)MF59

Experimental group

Description:

50% of MF59 with 3.75 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

7.5 w/o MF59

Experimental group

Description:

0% of MF59 with 7.5 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

7.5_(50)MF59

Experimental group

Description:

50% of MF59 with 7.5 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

7.5_(100)MF59

Experimental group

Description:

100% of MF59 with 7.5 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

15 w/o MF59

Experimental group

Description:

0% of MF59 with 15 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

15_(50)MF59

Experimental group

Description:

50% of MF59 with 15 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

15_(100)MF59

Experimental group

Description:

100% of MF59 with 15 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f

30 w/o MF59

Experimental group

Description:

0% of MF59 with 30 µg A/H1N1 antigen

Treatment:

Biological: MF59-eH1N1_f