Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Jul 13, 2015

Keywords

ClinConnect Summary

Although there are good reasons for women of reproductive age to participate in interventions that prevent cholera, cholera vaccination programs and studies have generally excluded pregnant women since there is little specific information on the safety of the vaccine during pregnancy. However, there are several biological reasons why inactivated OCVs are unlikely to have a harmful effect on fetal development. First, the bacteria in the vaccine are killed and do not replicate. Second, the vaccine antigens act locally on the gastrointestinal mucosa, are not absorbed, and do not enter the mate...

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • Women aged 15-49 years old at time of consent (all cohorts)
• • Urine sample provided if pregnancy test required (Not required if experienced delivery outcome between March 30 and enrollment date, OR visibly pregnant AND has due date indicated in Health Passport) (all cohorts)
• • Received at least one dose of OCV in 2015 (must be verified with OCV Vaccination Card) (Cohorts 1 \& 2)
• • Estimated last menstruation at least 3 weeks before the first dose of OCV received (Nsanje) or before March 30, 2015 (Chikwawa) (Cohorts 1 \& 3)
• • Estimated last menstruation at least 2 weeks after the final dose of OCV received (Nsanje) or after the last day of OCV Round 2 (Chikwawa) (Cohorts 2 \& 4)
• • Residing in Nsanje or Chikwawa Districts since the first day of the vaccination campaign (30 March 2015) (Cohorts 2 \& 3)
• • Provides informed consent (with additional consent by the parent or legal guardian for unmarried \<18 years old) (All Cohorts)
• Exclusion criteria:
• • Received at least one dose of OCV in 2015 (Cohorts 3 \& 4)
• • An otherwise eligible pregnant women who is unable to be contacted after the second attempt within 48 hours after the first attempt to enroll (All cohorts)