A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

Seqirus

Status and phase: Completed; Phase 2

Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus

Treatments: Biological: CSL425

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938639

CSLCT-CAL-09-59

Details and patient eligibility

About

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.

Enrollment: 240 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged >= 18 to < 65 years at the time of providing informed consent.

Exclusion criteria

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

CSL425 (15 mcg)

Experimental group

Description:

15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Treatment:

Biological: CSL425

Biological: CSL425

CSL425 (30 mcg)

Experimental group

Description:

30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Treatment:

Biological: CSL425

Biological: CSL425