Immunization; InfectionNCT04444518
Increasing Influenza and Tdap Vaccination of Pregnant Women
A study testing VAX-MOM Intervention in people with Immunization; Infection and Pregnancy Related, run by University of Rochester at 1 site in United States.
Trial summary
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunization; Infection, Pregnancy Related
- What is being tested?
- VAX-MOM Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,760 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients
- Sex is female
- Pregnant
- identified as being eligible for influenza or Tdap vaccine
- Providers
- any provider, nurse or staff associated with the participating sites
Who cannot join
- Patients
- none
- Providers
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center (URMC)
Rochester, New York, 14642
About this study
Official title: The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.
Read the detailed description
Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
- Conditions
- Immunization; Infection, Pregnancy Related
- Being tested
- VAX-MOM Intervention, Standard of Care
- Keywords
- pertussis, influenza, vaccination, prenatal care
- Medical subject headings
- Infections, Whooping Cough, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX-MOM InterventionBehavioural
The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
Standard of CareBehavioural
Standard vaccine education and processes provided to patients by obstetric practices.
| Study group | Role | What they receive |
|---|---|---|
| VAX-MOM Intervention | Experimental | Not described Receives: Behavioral: VAX-MOM Intervention |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Influenza Vaccination
Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Measured: 10/1/2021-6/30/2022 (intervention flu season)
Rate of Tdap Vaccination
Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Measured: 7/1/2021 - 6/30/2022 (intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immunization; InfectionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of California, Los Angeles
- Responsible party
- Principal investigator, Cynthia Rand, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444518
- Sponsor's protocol ID
- STUDY00005115
- Status last verified
- Nov 2024
- First submitted
- 19 Jun 2020
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with investigators upon request as part of a collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VAX-MOM Study: Increasing Influenza and Tdap Vaccination of Pregnant Women
- ClinicalTrials.gov ID
- NCT04444518
- Acronym / sponsor ID
- STUDY00005115
- Conditions
- Immunization; Infection, Pregnancy Related
- Keywords
- pertussis, influenza, vaccination, prenatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,760 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of California, Los Angeles
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.
Detailed description
Infants under 6 months of age at increased risk of both influenza (flu) and pertussis disease, and pregnant women risk serious illness and premature labor from flu. The Advisory Committee on Immunization Practices recommends that women receive a flu vaccine in flu season, and tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine during each pregnancy (ideally between 27-36 weeks) to lower the risk for flu and pertussis disease for themselves and their infants. However, only half of pregnant women in the US receive a flu and Tdap vaccine, respectively; only 33% of women receive both vaccines. Lack of vaccination stems from a combination of patient (lack of knowledge, vaccine hesitancy), provider (suboptimal communication skills, missed opportunities), and system (e.g. lack of standing orders and patient reminders) factors. An effective intervention is needed to improve flu and Tdap vaccination rates for pregnant women. To address these low vaccination rates the investigators plan to use a clustered RCT (randomizing practices), allocating half of the participating practice sites within each health system to the VAX-MOM intervention and the other half to standard of care. The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAX-MOM Intervention | Experimental | Behavioral: VAX-MOM Intervention |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients
- Sex is female
- Pregnant
- identified as being eligible for influenza or Tdap vaccine
- Providers
Key exclusion criteria (4 listed)
- Patients
- none
- Providers
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAX-MOM InterventionThe multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates. | Behavioural | VAX-MOM Intervention |
| Standard of CareStandard vaccine education and processes provided to patients by obstetric practices. | Behavioural | Standard of Care |
Primary outcome
Rate of Influenza Vaccination
Time frame: 10/1/2021-6/30/2022 (intervention flu season)
Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Rate of Tdap Vaccination
Time frame: 7/1/2021 - 6/30/2022 (intervention period)
Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared with investigators upon request as part of a collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAX-MOM Intervention in people with Immunization; Infection and Pregnancy Related, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Influenza Vaccination (time frame: 10/1/2021-6/30/2022 (intervention flu season)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.