Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000175875
Ethics application status
Not yet submitted
Date submitted
2/02/2012
Date registered
8/02/2012
Date last updated
14/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
FluMum: A prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in prevention of influenza in early infancy
Scientific title
FluMum: A prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in prevention of influenza in early infancy
Secondary ID [1] 279852 0
Nil
Universal Trial Number (UTN)
U1111-1127-8877
Trial acronym
FluMum
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 285738 0
Condition category
Condition code
Infection 285920 285920 0 0
Studies of infection and infectious agents
Public Health 285921 285921 0 0
Health service research
Reproductive Health and Childbirth 285959 285959 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Multi national, multi centred observational trial studying the effectiveness of maternal influenza immunisation in infants up to 6 months of age. The aim is to recruit about 420 women in Australia in each site each year so that, after 4 years, we expect to have just over 10,000 women and their babies who are part of the study. There are six sites: Darwin, Brisbane, Sydney, Melbourne, Adelaide and Perth.
Recruitment will be through ante-natal care providers, maternity units within participating hospitals or through clinics providing routine postnatal services at 6 weeks post delivery in Darwin, Brisbane, Sydney, Melbourne, Adelaide and Perth.
The study will be explained to potential participants utilising a Plain Language Statement approved by the relevant Human Research Committee (HREC).
The study is aimed at mothers immunised against Influenza in the 12 months prior to the birth of their infant. The vaccine must not have been given =<14 days prior to the birth of the infant.A minimal dataset summarising the outcomes from those approached for the Plain Language Statement will be recorded through a Screening Log.
Informed consent will be sought from each potential participant in accordance with HREC approval. Participant Workbook approved by the HREC will be used to document an entry questionnaire.
Brief maternal questionnaire administered at enrolment (maximum 55 days post delivery). Information sought will be limited to self-reported influenza vaccination status, information relating to the barriers/influences of influenza vaccination, contact details for the participant’s usual medical practitioner, self reported maternal medical/obstetric history, and some socio-demographic indicators.
The workbook is structured so that the component conducted at entry into the study can be completed over two separate sessions should the participant so choose.
The workbook also includes a telephone follow-up once the child reaches 6 months of age where parent reported episodes are sought for medically diagnosed influenza in the infant.
In addition to the informed consent process, the participant must also be considered to have sufficient verbal English to permit questionnaire completion at study entry and at 6-month follow-up.
Each participant’s usual medical practitioner/vaccine provider will be contacted to confirm the date of vaccination: (a) when a participant self reports receipt of influenza or pertussis vaccination but is unable to cite the date given from a written record; or (b) where the participant is unsure of her vaccination history. Participants who state that they have not been vaccinated will be considered unvaccinated to validate self-report of exposure status as vaccinated or unvaccinated.
Brief maternal telephone questionnaire at participant exit will be conducted once the child reaches 6 months of age, includes parent reported episodes of medically diagnosed influenza in the infant.
Data linkage to influenza and / or any other vaccine preventable diseases recorded on the notifiable diseases database within each State/Territory for the infant (6 months post delivery) and for maternal influenza from 12 months prior to delivery – 6 months post delivery will be undertaken.
Parent reported episodes of medically diagnosed influenza where a specimen was collected from the mother or the infant that were identified but not confirmed will be followed-up with the treating physician to establish if they were laboratory confirmed and had not been notified to the relevant public health authority.
Intervention code [1] 284172 0
Not applicable
Comparator / control treatment
A comparison of the cumulative incidence of laboratory-confirmed influenza in infants aged <6 months by treatment group (vaccinated cohort versus unvaccinated cohort)
Control group
Active

Outcomes
Primary outcome [1] 286450 0
Determine the effectiveness of maternal influenza vaccine in pregnancy using laboratory confirmed influenza results among infant offspring during the first 6-months of life.
Timepoint [1] 286450 0
during the first 6-months of life.
Secondary outcome [1] 295913 0
Determine influenza vaccine uptake during pregnancy at each of six sentinel research centres (Darwin, Brisbane, Sydney, Melbourne, Adelaide and Perth) during each of four consecutive years (2012, 2013, 2014, 2015).
This will be assessed by having each participant?s usual medical practitioner/vaccine provider contacted to confirm the date of vaccination: (a) when a participant self reports receipt of influenza or pertussis vaccination but is unable to cite the date given from a written record; or (b) where the participant is unsure of her vaccination history. Participants who state that they have not been vaccinated will be considered unvaccinated.
Timepoint [1] 295913 0
4 years

Eligibility
Key inclusion criteria
Delivery of a live-birth infant/s within 8 weeks of enrolment, ie maximum 55 days old at enrolment.
For non-Darwin sites, the infant/s must be delivered between 1 February and 30 September inclusive.
Restriction of recruitment on the aforementioned basis in temperate climates is expected to provide a median of 4 (range 2-6) months exposure to circulating influenza per infant during the first 6 months of life. A design efficiency, critical to the sample size calculation.
The maternal study participant must:
Be aged 18 years or more at the time written informed consent is obtained;
Be willing and able to adhere to all protocol requirements;
Have sufficient verbal English to permit questionnaire completion at study entry and at 6-month follow-up.
Minimum age
17 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Plan to move overseas before the infant reaches six (6) months of age

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4933 0
0811
Recruitment postcode(s) [2] 4934 0
2145
Recruitment postcode(s) [3] 4935 0
3010
Recruitment postcode(s) [4] 4932 0
4029
Recruitment postcode(s) [5] 4936 0
5006
Recruitment postcode(s) [6] 4937 0
6872

Funding & Sponsors
Funding source category [1] 284619 0
Government body
Name [1] 284619 0
National Health & Medical Research Council Project Grant
Country [1] 284619 0
Australia
Primary sponsor type
Individual
Name
A/Professor Ross Andrews
Address
Menzies School of Health Research
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus, Casuarina, NT 0811
Country
Australia
Secondary sponsor category [1] 283536 0
None
Name [1] 283536 0
Address [1] 283536 0
Country [1] 283536 0
Other collaborator category [1] 260481 0
Individual
Name [1] 260481 0
Dr Kerry-Ann O'Grady
Address [1] 260481 0
Queensland Children's Medical Research Institute,
University of Queensland
Level 4, Foundation Building, Royal Children?s Hospital, Herston Road, HERSTON, QLD 4029
Country [1] 260481 0
Australia
Other collaborator category [2] 260482 0
Individual
Name [2] 260482 0
Professor Terry Nolan
Address [2] 260482 0
Vaccine & Immunisation Research Group, Murdoch Children's Research Institute & School of Population Health, University of Melbourne
Level 5, 207 Bouverie Street
The University of Melbourne, Victoria 3010
Country [2] 260482 0
Australia
Other collaborator category [3] 260483 0
Individual
Name [3] 260483 0
A/Professor Peter Richmond
Address [3] 260483 0
Vaccine Trials Group, Telethon Institute for Child Health Research
PO Box 855
West Perth WA 6872
Country [3] 260483 0
Australia
Other collaborator category [4] 260484 0
Individual
Name [4] 260484 0
Dr Nicholas Wood
Address [4] 260484 0
National Centre for Immunisation Research and Surveillance,
University of Sydney
Sydney Children?s Hospitals Network
Locked Bag 4001, Westmead, NSW 2145
Country [4] 260484 0
Australia
Other collaborator category [5] 260485 0
Individual
Name [5] 260485 0
A/Professor Helen Marshall
Address [5] 260485 0
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and University of Adelaide
72 King William Rd
North Adelaide, SA 5006
Country [5] 260485 0
Australia
Other collaborator category [6] 260486 0
Individual
Name [6] 260486 0
A/Professor Stephen Lambert
Address [6] 260486 0
Queensland Children's Medical Research Institute,
University of Queensland
Level 4, Foundation Building, Royal Children?s Hospital, Herston Road, HERSTON, QLD 4029
Country [6] 260486 0
Australia
Other collaborator category [7] 260487 0
Individual
Name [7] 260487 0
Mr Mark Chatfield
Address [7] 260487 0
Menzies School of Health Research John Mathews Building (Bldg 58) Royal Darwin Hospital Campus, Casuarina, NT 0811
Country [7] 260487 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286611 0
Human Research Ethics Committee (HREC)
Ethics committee address [1] 286611 0
Menzies School of Health Research, Charles Darwin University
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Casuarina, NT 0811
Ethics committee country [1] 286611 0
Australia
Date submitted for ethics approval [1] 286611 0
26/02/2012
Approval date [1] 286611 0
Ethics approval number [1] 286611 0

Summary
Brief summary
"FluMum” is a study about flu vaccination in pregnancy. We want to find out whether or not you had a flu vaccine in the 12 months before your baby was born and then whether that helps to protect your baby from getting influenza during the first 6 months of infancy.
We ask questions and ask for permission to obtain information that may be kept in Government Health Departments. We don’t do any blood tests, give any injections or take any specimens. You don’t even have to have had the influenza vaccine to be in the study.
In Australia, flu vaccination is recommended for all pregnant women who will be in their second or third trimester during the flu season. The reason that the vaccine is recommended is to prevent illness during pregnancy, however, there is some evidence that giving the flu vaccine during pregnancy (and potentially in the 12 months prior to a baby being born) may be of benefit in protecting the baby from the flu during the first few months of life.
The study is being conducted in Darwin, Brisbane, Sydney, Melbourne, Adelaide and Perth. We will look at flu vaccine uptake pregnancy in the 12 months prior to the baby being born and the reasons why women do or don’t get vaccinated. Then we will find out whether babies of women vaccinated in the 12 months prior to a baby being born are less likely to get flu in the first few months of life than the babies of women who were not vaccinated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33718 0
Address 33718 0
Country 33718 0
Phone 33718 0
Fax 33718 0
Email 33718 0
Contact person for public queries
Name 16965 0
Lisa Mulhearn
Address 16965 0
Room 204, Level 2
Edith Cavell Building
Royal Children's Hospital Herston Brisbane Qld 4029
Country 16965 0
Australia
Phone 16965 0
+61 7 3636 1296
Fax 16965 0
+61 7 3636 5578
Email 16965 0
l.mulhearn1@uq.edu.au
Contact person for scientific queries
Name 7893 0
Dr Kerry-Ann O'Grady
Address 7893 0
Level 2
Edith Cavell Building
Royal Children's Hospital Herston Brisbane Qld 4029
Country 7893 0
Australia
Phone 7893 0
+61 7 3636 1296
Fax 7893 0
+61 7 3636 5578
Email 7893 0
k.ogrday@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFluMum: A prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in revention of influenza in early infancy.2014https://dx.doi.org/10.1136/bmjopen-2014-005676
N.B. These documents automatically identified may not have been verified by the study sponsor.