Improving vaccine uptake for pregnant women and at-risk children against influenza and COVID-19
Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study)
This study is testing new ways to encourage pregnant women and at-risk children to get vaccinated against influenza and COVID-19 to help keep them safe from serious illness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1038 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | University of Adelaide Academic / other |
| Locations | 7 sites (Adelaide, South Australia and 6 other locations) |
| Trial ID | NCT05613751 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the vaccination rates of pregnant women and medically at-risk children against influenza and COVID-19 through the development of 'nudge' interventions. These small environmental changes are designed to influence behavior positively and will be tested in randomized controlled trials. The study focuses on pregnant women who have received two or fewer doses of the COVID-19 vaccine and children aged 6 months to 18 years with specific chronic medical conditions. The goal is to address the significant vaccine hesitancy observed in these populations and improve their protection against severe outcomes from these infections.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who have received two or fewer doses of the COVID-19 vaccine and children aged 6 months to 18 years with specified chronic medical conditions.
Not a fit: Patients who are not pregnant or do not have chronic medical conditions may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase vaccination rates, thereby reducing hospitalizations and severe outcomes for pregnant women and at-risk children.
How similar studies have performed: Other studies have shown success with similar behavioral interventions to improve vaccination rates, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Adelaide, South Australia and 6 other locations
- Women's and Children's Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (Recruiting)
- Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (Recruiting)
- Mercy Hospital For Women — Heidelberg, Victoria, Australia (Recruiting)
- The Royal Children's Hospital — Parkville, Victoria, Australia (Recruiting)
- Perth Children's Hospital — Nedlands, Western Australia, Australia (Recruiting)
- King Edward Memorial Hospital — Subiaco, Western Australia, Australia (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.