Influenza Specific Immunity After Vaccination in Recipients of Haematopoietic Stem Cell Transplantation Compared to Healthy Controls

Phase 4

Completed

• Conditions: Haematopoietic Stem Cell Transplant patients; cancer; haematological malignancy; Autologous or allogeneic; Influenza; Cancer - Any cancer; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12614000240640
• Lead Sponsor: Princess Margaret Hospital for children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Age greater than or equal to 6 months to less than or equal to 18 years of age at time of vaccination and have undergone HSCT
2.HSCT recipients who are more than 6 months upto 2 years post transplant

Exclusion Criteria

1.Known contraindication to influenza vaccine as defined in the National Health and Medical Research Council (NHMRC) Immunisation Handbook (10th ed.)
2.Receipt of an inappropriate dose of influenza vaccine for age of child during the current year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure influenza specific Haemagglutinin Inhibition [HI] antibody levels by standarised method at WHO Collaborating Centre for Reference and Research on Influenza<br>[for one dose, prevaccinetion and between 4 to 8 weeks post dose. <br>For two doses, prevaccination and between 4 to 8 weeks post each dose. ]

Secondary Outcome Measures

Name	Time	Method
To identify the frequency and severity of microbiologically confirmed influenza illness in HSCT patients who received TIV during that influenza season. This is assessed by asking the patients to contact staff if they have an influenza like illness. If they fulfil the criteria, then they come in for medical assessment and nasal swab looking for respiratory viruses by IF +/_ PCR. If positive for influenza, the swab will be sent to WHO Collaborating Centre for Reference and Research on Influenza for specific strain typing to assess vaccine failure versus strain mismatch.<br><br>[Any time from enrolment to end of the influenza season (End of nov of enrolment year)]