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 children.

Official Title

A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL’s 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

Conditions

  • Influenza caused by the novel Influenza A (H1N1) virus

Study Type

Interventional

Study Design

Prevention, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

  • Immunogenicity
    [ Time Frame: 21 days after each vaccination ]
    [ Designated as safety issue: No ]

Secondary outcome measures  

  • Frequency,duration and intensity of solicited adverse events
    [ Time Frame: During the 7 days after each vaccination ]
    [ Designated as safety issue: Yes ]
  • Frequency, duration and intensity of unsolicited adverse events
    [ Time Frame: During the 21 days after each vaccination ]
    [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events, adverse events of special interest (AESIs) and new onset of chronic illnesses
    [ Time Frame: From the time of providing informed consent up to 180 days after the last vaccination ]
    [ Designated as safety issue: Yes ]


Study arms and assigned interventions

  1. 15 mcg HA dose group:
    • Experimental  15 mcg of HA antigen per dose
    • Biological: CSL’s 2009 H1N1 Influenza Vaccine (CSL425) 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
  2. 30 mcg HA dose group:
    • Experimental 30 mcg of HA antigen per dose
    • Biological: CSL’s 2009 H1N1 Influenza Vaccine (CSL425) 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

Study Start

June 2009 – March 2010

Eligibility & Criteria

  • Ages eligible for study: 6 months to 8 years
  • Genders eligible for study: Both
  • Accepts healthy volunteers: Yes

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 of gestation.

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.

Total Enrolment

400

Contact Details