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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05613751




Registration number
NCT05613751
Ethics application status
Date submitted
10/11/2022
Date registered
14/11/2022
Date last updated
17/01/2024

Titles & IDs
Public title
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
Scientific title
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
Secondary ID [1] 0 0
WCHN HREC/2022/HREC00082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Nudge

Experimental: Pregnant women-COVID-19 vaccine RCT - intervention group - Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine

No Intervention: Pregnant women-COVID-19 vaccine RCT - standard care group - Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.

Experimental: Pregnant women-influenza vaccine RCT - intervention group - Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine

No Intervention: Pregnant women-influenza vaccine RCT - standard care group - Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.

Experimental: Medically at risk children-COVID-19 vaccine RCT - intervention group - Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine

No Intervention: Medically at risk children-COVID-19 vaccine RCT - standard care group - Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.

Experimental: Medically at risk children-influenza vaccine RCT - intervention group - Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine

No Intervention: Medically at risk children-influenza vaccine RCT - standard care group - Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.


Behaviour: Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR).
Timepoint [1] 0 0
From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
Primary outcome [2] 0 0
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of the seasonal influenza vaccine, as assessed using the Australian Immunisation Register (AIR)
Timepoint [2] 0 0
Within 3 months after randomisation
Primary outcome [3] 0 0
To determine the proportion of pregnant women in intervention versus standard care arm receiving one dose of the COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
Timepoint [3] 0 0
From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
Primary outcome [4] 0 0
To determine the proportion of medically as risk children in the intervention versus standard care group receiving at least one dose of a COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR)
Timepoint [4] 0 0
Within 3 months after randomisation
Secondary outcome [1] 0 0
Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics
Timepoint [1] 0 0
From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Secondary outcome [2] 0 0
Number of medically at risk children who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics
Timepoint [2] 0 0
From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
Secondary outcome [3] 0 0
To assess timeliness of influenza/ COVID-19 vaccine uptake among pregnant women during the study period by determining the proportion of pregnant women who receive the influenza or COVID-19 vaccine by month throughout the study period.
Timepoint [3] 0 0
From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Secondary outcome [4] 0 0
To assess timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month.
Timepoint [4] 0 0
From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
Secondary outcome [5] 0 0
To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings
Timepoint [5] 0 0
From the date of randomisation until 46 weeks after randomisation
Secondary outcome [6] 0 0
To determine the difference in proportion of pregnant women in intervention versus standard care arm receiving one dose of the influenza/COVID-19 vaccine, as assessed using the Australian Immunisation Register (AIR).
Timepoint [6] 0 0
From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week

Eligibility
Key inclusion criteria
- COVID-19 pregnant women RCT: Pregnant women have received 2 or less doses of a
recommended COVID-19 vaccine

- Influenza pregnant women RCT: Pregnant women have not received the influenza vaccine
during pregnancy

- COVID-19 medically at risk children RCT: Medically at risk children aged 5 years to 18
years with a cardiac, endocrine, respiratory, gastrointestinal, haematological,
musculoskeletal, neurological condition

- Influenza medically at risk children RCT: Children aged =6 months and < 18 years with
medical conditions specified in this list: immunocompromising conditions including
malignancy, chronic steroid use, haematopoietic stem cell transplant; functional or
anatomical asplenia including sickle cell disease or other haemoglobinopathies,
congenital or acquired asplenia (for example, splenectomy) or hyposplenia; cardiac
disease including cyanotic congenital heart disease, congestive heart failure,
coronary artery disease; chronic respiratory conditions including suppurative lung
disease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease,
severe asthma (requiring frequent medical consultations or the use of multiple
medicines); chronic neurological conditions including hereditary and degenerative CNS
diseases, seizure disorders, spinal cord injuries, neuromuscular disorders; chronic
metabolic disorders including Type 1 or 2 diabetes, amino acid disorders, carbohydrate
disorders, cholesterol biosynthesis disorders, fatty acid oxidation defects, lactic
acidosis, mitochondrial disorders, organic acid disorders, urea cycle disorders,
vitamin/cofactor disorders, porphyria; chronic renal failure; children aged 5 to 10
years receiving long term aspiring therapy; Down syndrome; obesity (body mass index
=30 kg/m2); children born less than 37 weeks gestation
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- COVID-19 pregnant women RCT: Pregnant women have contraindications to COVID-19
vaccines and already randomised to influenza RCT.

- Influenza pregnant women RCT: Pregnant women have contraindications to Influenza
vaccines and already randomised to COVID-19 RCT.

- COVID-19 medically at risk children RCT:

- Known contraindications to COVID-19 vaccine

- Up to date for COVID-19 vaccine (= two doses) at the time of enrolment,

- Sibling of a child already enrolled in the trial (only the sibling who is
eligible and scheduled to attend a paediatric clinic first will be eligible)

- Previous participation in the influenza nudge RCT

- Influenza medically at risk children RCT:

- Known contraindications to influenza vaccine

- Already received an influenza vaccine during the flu season in 2023

- Sibling of a child already participating in the trial (the sibling who is
eligible and scheduled to attend a paediatric clinic first will be eligible)

- Previous participation in the COVID-19 nudge RCT

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1038
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 0 0
Mercy Hospital For Women - Heidelberg
Recruitment hospital [5] 0 0
The Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [7] 0 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Pregnant women and children with chronic medical conditions are at increased risk of
hospitalisation, intensive care admission and death from influenza and COVID-19 infections.
However, there appears to be a high level of vaccine hesitancy among women of reproductive
age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake and
test the effectiveness of the interventions using randomised controlled trials in

- pregnant women

- medically at risk children.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05613751
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05613751