Clinical trial NCT05613751: Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children
Official title: Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Influenza
COVID-19
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 1038
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four multi-centre, parallel group, superiority, randomized control trials (with 1:1 allocation) of nudge interventions to improve influenza and COVID-19 vaccine uptake among pregnant women and medically at risk children. Each RCT will enroll 1038 participants (n = 519 each in intervention and control groups), with a total of 4154 participants in the four RCTs:

* pregnant women's RCTs

  * COVID-19 vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
  * Influenza vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
* medically at-risk children's RCTs

  * COVID-19 vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)
  * Influenza vaccine (n= 1038): Arm #1 (Standard care, n=519); Arm #2 (Nudge intervention, n=519)

There are eight arms in total for four RCTs.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
measure: 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)
timeFrame: Within 3 months after randomisation
measure: 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).
timeFrame: From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
measure: 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)
timeFrame: Within 3 months after randomisation
Secondary outcomes:
measure: Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics
timeFrame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
measure: 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
timeFrame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
measure: 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.
timeFrame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
measure: 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.
timeFrame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
measure: To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings
timeFrame: From the date of randomisation until 46 weeks after randomisation
measure: 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).
timeFrame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Mercy Hospital For Women
state: Victoria
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: King Edward Memorial Hospital
state: Western Australia
Study officials:
References: