Trial Outcomes & Findings for Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi (NCT NCT02499172)
NCT ID: NCT02499172
Last Updated: 2024-01-03
Results Overview
The primary analysis will compare adverse pregnancy outcome (miscarriage and stillbirth) in Cohorts 1 and 3.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2758 participants
Primary outcome timeframe
Upto 42 weeks from the date of last menstrual period
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Cohort 1
Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 3
Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
Non-intervention: Non recipients of the vaccine
|
Cohort 2
Cohort 2: Women who were not pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 4
Cohort 4: Women who were not pregnant and not received any dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
900
|
899
|
523
|
436
|
|
Overall Study
COMPLETED
|
835
|
835
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
65
|
64
|
523
|
436
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 3
Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
Non-intervention: Non recipients of the vaccine
|
Cohort 2
Cohort 2: Women who were not pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 4
Cohort 4: Women who were not pregnant and not received any dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
|---|---|---|---|---|
|
Overall Study
Financial reason
|
0
|
0
|
523
|
436
|
|
Overall Study
Lost to Follow-up
|
65
|
64
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=835 Participants
Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 3
n=835 Participants
Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
Non-intervention: Non recipients of the vaccine
|
Cohort 2
n=523 Participants
Cohort 2: Women who were not pregnant in at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
|
Cohort 4
n=436 Participants
Cohort 4: Women from Chikwawa who were not pregnant in at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
|
Total
n=2629 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.93 years
STANDARD_DEVIATION 6.51 • n=835 Participants
|
25.75 years
STANDARD_DEVIATION 6.81 • n=835 Participants
|
24.24 years
STANDARD_DEVIATION 6.51 • n=523 Participants
|
25.32 years
STANDARD_DEVIATION 6.61 • n=436 Participants
|
25.84 years
STANDARD_DEVIATION 6.66 • n=2629 Participants
|
|
Sex: Female, Male
Female
|
835 Participants
n=835 Participants
|
835 Participants
n=835 Participants
|
523 Participants
n=523 Participants
|
436 Participants
n=436 Participants
|
2629 Participants
n=2629 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=835 Participants
|
0 Participants
n=835 Participants
|
0 Participants
n=523 Participants
|
0 Participants
n=436 Participants
|
0 Participants
n=2629 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Malawi
|
835 participants
n=835 Participants
|
835 participants
n=835 Participants
|
523 participants
n=523 Participants
|
436 participants
n=436 Participants
|
1670 participants
n=2629 Participants
|
PRIMARY outcome
Timeframe: Upto 42 weeks from the date of last menstrual periodThe primary analysis will compare adverse pregnancy outcome (miscarriage and stillbirth) in Cohorts 1 and 3.
Outcome measures
| Measure |
Cohort 1
n=835 Participants
Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Shanchol: Oral cholera vaccine
|
Cohort 3
n=835 Participants
Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
Non-intervention: Non recipients of the vaccine
|
Cohort 2
n=523 Participants
Cohort 2: Women who were not pregnant at the time of the vaccination campaign in Nsanje District, but who received receive the vaccine during the campaign.
|
Cohort 4
n=436 Participants
Cohort 4: Women who were not pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
|
|---|---|---|---|---|
|
Adverse Pregnancy Outcome
|
46 Participants
|
36 Participants
|
19 Participants
|
18 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
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
Dr. Mohammad Ali
Johns Hopkins Bloomberg School of Public Health
Phone: 410-502-3154
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place