None listed
Conditions
Brief summary
This is a safety study of quadrivalent inactivated influenza virus vaccine, Afluria Quad and Afluria Quad Junior, conducted over three Southern Hemisphere vaccination seasons to provide ongoing characterisation of the reactogenicity profile of Afluria Quad in the clinical and public health environment.
Interventions
Afluria Quad/Afluria Quad Junior
Afluria Quad/Afluria Quad Junior is an inactivated, split-virion, quadrivalent influenza vaccine, administered as either one or two intramuscular dose(s) depending on their previous history of influenza virus vaccination according to age appropriate national vaccine administration recommendations outlined in the Australian or New Zealand Immunisation Handbooks. Participants with previous history of influenza virus vaccination will receive 1 dose; and participant
Afluria Quad/Afluria Quad Junior Afluria Quad/Afluria Quad Junior is an inactivated, split-virion, quadrivalent influenza vaccine, administered as either one or two intramuscular dose(s) depending on their previous history of influenza virus vaccination according to age appropriate national vaccine administration recommendations outlined in the Australian or New Zealand Immunisation Handbooks. Participants with previous history of influenza virus vaccination will receive 1 dose; and participants 6 months to <9 years receiving an influenza vaccine for the first time will receive 2 doses. In each vaccination season, participants 6 months to less than 3 years will be randomly administered one of three manufacturing batches of Afluria Quad Junior, and participants 3 years to less than 9 years will be randomly administered one of three manufacturing batches of Afluria Quad vaccine. Participants will receive the following dose depending upon their age at the time of administration of the first dose of Study Vaccine: - 6 months to less than 3 years of age: 1 or 2 doses of 7.5 mcg hemagglutinin antigen - 3 years to less than 9 years of age: 1 or 2 doses of 15 mcg hemagglutinin antigen
Sponsors
Seqirus
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 8 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects 6 months to less than 9 years of age at the time of planned first vaccination in a given season; 2. Subjects whose parent(s)/guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry and are willing and able to adhere to all protocol requirements.
Exclusion criteria
1. History of severe allergic reactions (eg, anaphylaxis) to any component of the Study Vaccine or to a previous dose of any influenza vaccine. 2.Participant has received a licensed or investigational influenza vaccine in the 6 month period prior to enrolment. 3. Family members of the employees of the Investigator or study centre with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study centre. 4. Any other condition that per the opinion of the investigator may adversely impact the subject through participation in the study.
Outcome results
None listed