Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza

Treatments: Biological: MF59-eH1N1_f

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996307

V112_06

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Enrollment: 654 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children 6 to 35 months 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: Double Blind

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654 participants in 4 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_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

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_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

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_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

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_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f

Biological: MF59-eH1N1_f