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

January 12, 2024 updated by: Helen Marshall, University of Adelaide

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1038

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5006
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
      • Elizabeth Vale, South Australia, Australia, 5112
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Mercy Hospital for Women
        • Contact:
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • The Royal Children's Hospital
        • Contact:
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
      • Subiaco, Western Australia, Australia, 6008
        • Not yet recruiting
        • King Edward Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pregnant women-COVID-19 vaccine RCT - intervention group
Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine
Behavioral: Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
No Intervention: Pregnant women-COVID-19 vaccine RCT - standard care group
Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the COVID-19 booster vaccine. They will receive normal care at the hospital.
Experimental: Pregnant women-influenza vaccine RCT - intervention group
Women randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine
Behavioral: Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
No Intervention: Pregnant women-influenza vaccine RCT - standard care group
Women randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get the annual influenza vaccine. They will receive normal care at the hospital.
Experimental: Medically at risk children-COVID-19 vaccine RCT - intervention group
Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine
Behavioral: Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
No Intervention: Medically at risk children-COVID-19 vaccine RCT - standard care group
Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the COVID-19 vaccine. They will receive normal care at the hospital.
Experimental: Medically at risk children-influenza vaccine RCT - intervention group
Parents of medically at risk children randomized to the intervention group will receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine
Behavioral: Nudge
Three text messages that are sent four weeks apart reminding to obtain the vaccines
No Intervention: Medically at risk children-influenza vaccine RCT - standard care group
Parents of medically at risk children randomized to the standard care group will not receive the nudge (three text messages four weeks apart) to remind them to get their child the annual influenza vaccine. They will receive normal care at the hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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).
From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
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)
Time Frame: 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).
Within 3 months after randomisation
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).
Time Frame: 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).
From the date of randomisation until the date of first documented delivery, assessed up to 42 weeks
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)
Time Frame: 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).
Within 3 months after randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of pregnant women who received COVID-19 or influenza vaccines, change from baseline to one month post-delivery, based on socio-demographic characteristics
Time Frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
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
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
Time Frame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
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
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.
Time Frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 weeks
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
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.
Time Frame: From date of randomisation until the date of first documented influenza or COVID-19 vaccination, assessed up to 3 months
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
To estimate the cost-effectiveness of proven interventions compared to standard care in hospital settings
Time Frame: From the date of randomisation until 46 weeks after randomisation
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
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).
Time Frame: From the date of randomisation until one month after the date of first documented delivery, assessed up to 46 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Adelaide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCHN HREC/2022/HREC00082

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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