Last updated: January 12, 2024
Sponsor: University of Adelaide
Overall Status: Active - Recruiting
Phase
N/A
Condition
Influenza
Covid-19
Treatment
Nudge
Clinical Study ID
NCT05613751
WCHN HREC/2022/HREC00082
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- COVID-19 pregnant women RCT: Pregnant women have received 2 or less doses of arecommended COVID-19 vaccine
- Influenza pregnant women RCT: Pregnant women have not received the influenza vaccineduring pregnancy
- COVID-19 medically at risk children RCT: Medically at risk children aged 5 years to 18years with a cardiac, endocrine, respiratory, gastrointestinal, haematological,musculoskeletal, neurological condition
- Influenza medically at risk children RCT: Children aged ≥6 months and < 18 years withmedical conditions specified in this list: immunocompromising conditions includingmalignancy, chronic steroid use, haematopoietic stem cell transplant; functional oranatomical asplenia including sickle cell disease or other haemoglobinopathies,congenital or acquired asplenia (for example, splenectomy) or hyposplenia; cardiacdisease including cyanotic congenital heart disease, congestive heart failure,coronary artery disease; chronic respiratory conditions including suppurative lungdisease, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease,severe asthma (requiring frequent medical consultations or the use of multiplemedicines); chronic neurological conditions including hereditary and degenerative CNSdiseases, seizure disorders, spinal cord injuries, neuromuscular disorders; chronicmetabolic disorders including Type 1 or 2 diabetes, amino acid disorders, carbohydratedisorders, cholesterol biosynthesis disorders, fatty acid oxidation defects, lacticacidosis, mitochondrial disorders, organic acid disorders, urea cycle disorders,vitamin/cofactor disorders, porphyria; chronic renal failure; children aged 5 to 10years receiving long term aspiring therapy; Down syndrome; obesity (body mass index ≥30 kg/m2); children born less than 37 weeks gestation
Exclusion
Exclusion Criteria:
- COVID-19 pregnant women RCT: Pregnant women have contraindications to COVID-19vaccines and already randomised to influenza RCT.
- Influenza pregnant women RCT: Pregnant women have contraindications to Influenzavaccines 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 iseligible 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 iseligible and scheduled to attend a paediatric clinic first will be eligible)
- Previous participation in the COVID-19 nudge RCT
Study Design
Total Participants: 1038
Treatment Group(s): 1
Primary Treatment: Nudge
Phase:
Study Start date:
October 26, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Women's and Children's Hospital
Adelaide, South Australia 5006
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaActive - Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
AustraliaActive - Recruiting
Mercy Hospital For Women
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
The Royal Children's Hospital
Parkville, Victoria 3052
AustraliaActive - Recruiting
Perth Children's Hospital
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
King Edward Memorial Hospital
Subiaco, Western Australia 6008
AustraliaSite Not Available
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