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

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

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.

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

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.

Connect with a study center

  • Women's and Children's Hospital

    Adelaide, South Australia 5006
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia 5112
    Australia

    Active - Recruiting

  • Mercy Hospital For Women

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • The Royal Children's Hospital

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • King Edward Memorial Hospital

    Subiaco, Western Australia 6008
    Australia

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.