Trial Outcomes & Findings for Increasing Influenza and Tdap Vaccination of Pregnant Women (NCT NCT04444518)
NCT ID: NCT04444518
Last Updated: 2025-01-10
Results Overview
Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12760 participants
Primary outcome timeframe
10/1/2021-6/30/2022 (intervention flu season)
Results posted on
2025-01-10
Participant Flow
Unit of analysis: Practices
Participant milestones
| Measure |
VAX-MOM Intervention
VAX-MOM Intervention: The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
|
Standard of Care
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Overall Study
STARTED
|
5992 12
|
6768 15
|
|
Overall Study
COMPLETED
|
5992 12
|
6768 15
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
Baseline characteristics by cohort
| Measure |
VAX-MOM Intervention
n=5992 Participants
VAX-MOM Intervention: The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
|
Standard of Care
n=6768 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
Total
n=12760 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
129 Participants
n=5966 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
118 Participants
n=6755 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
247 Participants
n=12721 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
|
Age, Categorical
Between 18 and 65 years
|
5837 Participants
n=5966 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
6637 Participants
n=6755 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
12474 Participants
n=12721 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5966 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
0 Participants
n=6755 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
0 Participants
n=12721 Participants • Regarding the counts for "Age, Categorical," date of birth (DOB) was unavailable in the EHR for 39 total subjects and thus, age could not be calculated. Due to this, 26 subjects have an unknown age in the "Intervention" group, and 13 subjects have an unknown age in the "Standard of Care" group.
|
|
Sex: Female, Male
Female
|
5992 Participants
n=5992 Participants
|
6768 Participants
n=6768 Participants
|
12760 Participants
n=12760 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5992 Participants
|
0 Participants
n=6768 Participants
|
0 Participants
n=12760 Participants
|
|
Race/Ethnicity, Customized
Asian
|
430 Participants
n=5992 Participants
|
526 Participants
n=6768 Participants
|
956 Participants
n=12760 Participants
|
|
Race/Ethnicity, Customized
Black
|
694 Participants
n=5992 Participants
|
1266 Participants
n=6768 Participants
|
1960 Participants
n=12760 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
547 Participants
n=5992 Participants
|
721 Participants
n=6768 Participants
|
1268 Participants
n=12760 Participants
|
|
Race/Ethnicity, Customized
White
|
1831 Participants
n=5992 Participants
|
2016 Participants
n=6768 Participants
|
3847 Participants
n=12760 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2490 Participants
n=5992 Participants
|
2239 Participants
n=6768 Participants
|
4729 Participants
n=12760 Participants
|
|
Region of Enrollment
United States
|
5992 participants
n=5992 Participants
|
6768 participants
n=6768 Participants
|
12760 participants
n=12760 Participants
|
PRIMARY outcome
Timeframe: 10/1/2021-6/30/2022 (intervention flu season)Population: Pregnant during flu season
Influenza vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Outcome measures
| Measure |
VAX-MOM Intervention
n=4609 Participants
VAX-MOM Intervention: The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
|
Standard of Care
n=5294 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Rate of Influenza Vaccination
|
2382 participants
|
2496 participants
|
PRIMARY outcome
Timeframe: 7/1/2021 - 6/30/2022 (intervention period)Population: Pregnant individuals during study period
Tdap vaccination rate during pregnancy. Vaccination status will be obtained from patient electronic health records.
Outcome measures
| Measure |
VAX-MOM Intervention
n=5992 Participants
VAX-MOM Intervention: The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts, standing orders, and feedback on vaccination rates.
|
Standard of Care
n=6768 Participants
Standard of Care: Standard vaccine education and processes provided to patients by obstetric practices.
|
|---|---|---|
|
Rate of Tdap Vaccination
|
4532 participants
|
5452 participants
|
Adverse Events
VAX-MOM Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place