FluBub Study: Early influenza vaccination in infants

Phase 2

Recruiting

• Conditions: Influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12620000644965
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

The age of infants was made consistent throughout the protocol at 6 to <12 weeks as the inclusion criteria. This change occurred in Protocol v7.1 dated 10 November 2020.

The mothers' year of birth was removed. to address obstacles to eligibility without compromising the study outcomes. This change occurred in Protocol v4.0 dated 21 April 2020.

Infants will be enrolled in the study only if, in the opinion of the investigator, they and their mothers are considered able and likely to comply with the requirements of the research protocol.

Arm 4, infants born to mothers with confirmed influenza infection was removed from Protocol v11 dated 17 October 2022 due to the low incidence of influenza cases and low recruitment numbers. Removal of this exploratory Arm will not compromise the study endpoints.

Exclusion Criteria

1)Infants born <37 weeks or >42 weeks gestation;
2)Infants with congenital malformations, immunodeficiency or receiving immunosuppressive therapy
3)Infants born to mothers with immunodeficiency or receiving immunosuppressive therapy;
4)Infants previously receiving any monoclonal or polyclonal antibody (e.g, IV immunoglobulin);
5)Infants currently enrolled in a clinical trial for a drug or vaccine.
6)Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
7)infants whose parents/guardians are unwilling to comply with study requirements and follow-up until at least 8 months of age;
8)Children of employees of the clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified