A study to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
- Conditions
- Influenza, human.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-005183-15-Outside-EU/EEA
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 400
• 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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.
• Participants with confirmed or suspected 2009 H1N1 infection or those who had received an experimental vaccine during the preceding 6 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the immunogenicity of the 15 µg haemagglutinin (HA) and 30 µg HA antigen doses of 2009 H1N1 vaccine (H1N1 vaccine) in two cohorts of healthy children: Cohort A: participants aged 6 months to less than 3 years ; Cohort B: participants aged 3 years to less than 9 years.;Secondary Objective: To assess the safety and tolerability of 15 µg HA and 30 µg HA doses of H1N1 vaccine in two cohorts of healthy children.;Primary end point(s): The proportion of participants achieving either seroconversion or a significant increase in HI antibody titre after each dose.<br>The geometric mean fold increase (GMFI) of the HI antibody titre after each dose.<br>The proportion of participants achieving seroprotection.;Timepoint(s) of evaluation of this end point: 21 days after each vaccination.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The frequency, duration and intensity of solicited Adverse Events (AEs).<br>The frequency, duration and intensity of unsolicited AEs.<br>Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs).;Timepoint(s) of evaluation of this end point: 7, 21, and up to 180 days after each vaccination.