Paediatric Influenza Vaccine Outcome Trial (PIVOT)

Phase 3

Completed

• Conditions: Influenza; influenza infection during winter season; Infection - Other infectious diseases

• Registration Number: ACTRN12610000319077
• Lead Sponsor: Australian Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Male or female aged greater than or equal to 6 months to <48months at 1st march 2011; who will comply with the requirements of the protocol (e.g. completion of the diaries, return for the follow-up visit). The parent’s/guardian’s ability to understand English is sufficient not to impede the ability to give properly informed consent

Exclusion Criteria

Systemic hypersensitivity to egg proteins, chicken proteins, or any of the vaccine components for the vaccine group. Unstable chronic illness; Known history of Guillain-Barre Syndrome; Plans to enter another clinical trial, or receive an investigational product after receiving vaccine for this trial any time before 31 October 2010; Thrombocytopenia or bleeding disorder and History of psychiatric disorders in the parent/guardian providing consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified