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

Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A

Time frame: During the 7 days after each study vaccination

Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B

Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged \>= 3 years)for injection site pain; Size \> 30 mm for injection site redness and injection site induration/swelling; Oral temperature \> 104.0°F (40.0°C) or axillary temperature \> 103.1°F (39.5°C) for fevers.

Time frame: During the 7 days after each study vaccination

Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B

Time frame: During the 7 days after each study vaccination

Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination

UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.

Time frame: During the 21 days after each vaccination

Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)

A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).

Time frame: Up to 180 days after the last vaccination