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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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05613751