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

Seqirus

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958243

CSLCT-CAL-09-62

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Enrollment: 473 patients

Sex: All

Ages: 6 months to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
• For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.

Exclusion criteria

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, 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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473 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo

CSL425 (7.5 mcg)

Experimental group

Description:

7.5 mcg of hemagglutinin antigen per dose

Treatment:

Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

CSL425 (15 mcg)

Experimental group

Description:

15 mcg of hemagglutinin antigen per dose

Treatment:

Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)