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

Seqirus

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: CSL425; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958126

CSLCT-CAL-09-61

Details and patient eligibility

About

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

Enrollment: 1,313 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged 18 and older, inclusive, at the time of providing informed consent.
• Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion criteria

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, 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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1,313 participants in 4 patient groups, including a placebo group

CSL425 (7.5 mcg)

Experimental group

Description:

7.5 mcg of hemagglutinin 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 (15 mcg)

Experimental group

Description:

15 mcg of hemagglutinin 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 hemagglutinin 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

Placebo

Placebo Comparator group

Description:

Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Treatment:

Biological: Placebo