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Trial details imported from ClinicalTrials.gov

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes

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
Other
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)

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/study/NCT05613751
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/study/NCT05613751