Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children

COVID-19 Clinical Trial

Official title:

Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613751
• Other study ID #: WCHN HREC/2022/HREC00082
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnant women and children with chronic medical conditions are at an unacceptable risk of hospitalisation and death from influenza and COVID-19 infections. Pregnant women are 3 times more likely to die from COVID-19 and over 7 times more likely to be admitted to an intensive care unit (ICU) with influenza compared to non-pregnant women. Children with chronic disease are already compromised with a higher risk of hospitalisation from influenza and requirement for ICU management and long term disability following COVID-19. Uptake of the recommended influenza vaccine among pregnant women and medically at risk children in Australia is only ~50%. Based on recent surveys, the predicted uptake of COVID-19 vaccine among both groups is also likely to be ~50%. These two groups preferentially receive care from medical specialists (obstetricians and paediatricians) and specialist nursing staff in hospitals, and are less likely to engage with primary care, the usual providers of immunisation. The aim of this project is to develop a nudge (i.e. small changes in the environment that alter people's behaviour) and evaluate the effectiveness of the nudge intervention in improving the uptake of COVID and influenza vaccine by conducting four randomised control trials in - pregnant women - medically at risk children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1038
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

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

Related Conditions & MeSH terms

• COVID-19
• Influenza
• Influenza, Human

Intervention

Behavioral:
• Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines

Locations

Country	Name	City	State
Australia	Women's and Children's Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Mercy Hospital For Women	Heidelberg	Victoria
Australia	Perth Children's Hospital	Nedlands	Western Australia
Australia	The Royal Children's Hospital	Parkville	Victoria
Australia	King Edward Memorial Hospital	Subiaco	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one dose of influenza vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).	From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
Primary	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)	The difference in proportion of medically as risk children in the intervention versus standard care (non-intervention) group receiving at least one dose of the seasonal influenza vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).	Within 3 months after randomisation
Primary	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).	The difference in proportion of pregnant women in the intervention versus standard care (non-intervention) group receiving one or more doses of a COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).	From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
Primary	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)	The difference in proportion of medically at risk children receiving at least one dose of a COVID-19 vaccine within 3 months after randomisation will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).	Within 3 months after randomisation
Secondary	Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics	Number of pregnant participants who received COVID-19 or influenza vaccines, change from baseline up to one month post-delivery, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR).	From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Secondary	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	Number of medically at risk pediatric participants who received COVID-19 or influenza vaccines, change from baseline up to three months post-randomisation, based on socio-demographic characteristics using the hospital records and Australian Immunisation Register (AIR).	From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
Secondary	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.	Timeliness of influenza and COVID-19 vaccine uptake among pregnant women during the study period will be assessed by determining the difference in proportion of pregnant women who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR).	From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
Secondary	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.	Timeliness of influenza and COVID-19 vaccine uptake among medically at risk children during the study period by determining the difference in proportion of medically at risk children who receive the COVID-19 or influenza vaccine by month throughout the study period using the vaccination status data recorded in the Australian Immunisation Register (AIR).	From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
Secondary	To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings	The incremental cost per additional person vaccinated will be assessed by comparing interventions to standard care in hospital settings. The cost per quality-adjusted life year (QALY) gained for influenza vaccination will be assessed. Implementation costs will be obtained from the study budget and costs related to research activities will be excluded. Estimated cost offsets to the health system associated with influenza related disease (e.g. hospitalisations and emergency visits) will be derived from the literature and calculated using cost weights for Australian Refined Diagnosis Related Groups (AR-DRGs).	From the date of randomisation until 46 weeks after randomisation
Secondary	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).	The difference in proportion of pregnant women who receive one dose of influenza/COVID-19 vaccine from the time of randomisation during pregnancy until one month after delivery will be assessed using the vaccination status data recorded in the Australian Immunisation Register (AIR).	From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week