Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

Novartis

Status and phase: Completed; Phase 3

Conditions: Novel 2009 Influenza H1N1

Treatments: Biological: eH1N1_f; Biological: MF59-eH1N1_f

Study type: Interventional

Funder types: Industry

Identifiers

NCT00973700

V112_04

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 healthy young children, adolescents, and adults.

Enrollment: 784 patients

Sex: All

Ages: 3 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children, adolescents, and adults 3 to 64 years of age 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.

For additional entry criteria, please refer to protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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784 participants in 5 patient groups

2x7.5adj

Experimental group

Description:

Two doses of MF59 adjuvanted (adj) A/H1N1

Treatment:

Biological: MF59-eH1N1_f

7.5adj_1_8

Experimental group

Description:

MF59 adjuvanted (adj) A/H1N1 on days 1 and 8

Treatment:

Biological: MF59-eH1N1_f

7.5adj_1_22

Experimental group

Description:

MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22

Treatment:

Biological: MF59-eH1N1_f

15_1_22

Experimental group

Description:

A/H1N1 on study days 1 and 22

Treatment:

Biological: eH1N1_f

2x15_1_22

Experimental group

Description:

Two doses of A/H1N1 (one in each arm) on study days 1 and 22

Treatment:

Biological: eH1N1_f