Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza

Treatments: Biological: MF59-eH1N1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972816

V112_02

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.

Enrollment: 1,357 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children 3 to < 9 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: Single Blind

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1,357 participants in 8 patient groups

3.75_(50)MF59

Experimental group

Description:

3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

7.5_(0) MF59

Experimental group

Description:

7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

7.5_(50) MF59

Experimental group

Description:

7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

7.5_(100) MF59

Experimental group

Description:

7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

15_(0) MF59

Experimental group

Description:

15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

15_(50)MF59

Experimental group

Description:

15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

15_(100) MF59

Experimental group

Description:

15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1

30_(0) MF59

Experimental group

Description:

30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Treatment:

Biological: MF59-eH1N1