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: EUCTR2015-000176-10-Outside-EU/EEA
• Lead Sponsor: CSL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 450

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 450
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

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.
• 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 7.5 µg haemagglutinin (HA) and 15 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 7.5 µg HA and 15 µg HA doses of H1N1 vaccine in two cohorts of healthy children.;Primary end point(s): Seroconversion Rate 21 Days After First Study Vaccination.<br>Seroconversion Rate 21 Days After Second Study Vaccination.<br>Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination.<br>Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination.;Timepoint(s) of evaluation of this end point: 21 days after each vaccination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A.<br>Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A.<br>Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort B.<br>Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B.<br>Frequency and intensity of unsolicited AEs (UAE) occurring After the First or Second Study Vaccination.<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.