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Studies

Interventional Recruiting

NCT05613751 on ClinicalTrials.gov

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)

  • Sponsor: University of Adelaide
  • Enrollment: 1038 (Estimated)
  • Study start: 2022-10-26 (Actual)
  • Primary completion: 2024-06-30 (Estimated)
  • Study completion: 2024-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: Double (Participant, Outcomes Assessor)
  • PrimaryPurpose: 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.

Conditions

  • Influenza
  • COVID-19

Intervention / Treatment

  • Behavioral: Nudge

Primary Outcome Measures

  • 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). (From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks)
    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).
  • 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) (Within 3 months after randomisation)
    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).
  • 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). (From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks)
    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).
  • 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) (Within 3 months after randomisation)
    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).

Countries

Australia

Locations and Investigators

  • Women's and Children's Hospital, Adelaide, Australia (Recruiting)
    • Helen Marshall, MBBS, MD
    • Prabha Andraweera, MBBS, PhD
  • Flinders Medical Centre, Bedford Park, Australia (Recruiting)
    • Dylan Mordaunt, FRACP
  • Lyell McEwin Hospital, Elizabeth Vale, Australia (Recruiting)
    • Gus Dekker, MD, FFANZCOG
    • Dimi Simatos, FRACP
  • Mercy Hospital For Women, Heidelberg, Australia (Recruiting)
  • The Royal Children's Hospital, Parkville, Australia (Recruiting)
  • Perth Children's Hospital, Nedlands, Australia (Recruiting)
    • Christopher Blyth, FRACP
  • King Edward Memorial Hospital, Subiaco, Australia (Not yet recruiting)
    • Christopher Blyth, FRACP