Reactogenicity Study of Afluria Quad/Afluria Quad Junior in Childre

Phase 3

• Conditions: Influenza, Humans; Infection - Other infectious diseases; Public Health - Other public health

• Registration Number: ACTRN12619000792123
• Lead Sponsor: Seqirus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-29
• Study Completion: 2020-08-11
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 1056

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified