drugset / Trial / NCT02301702

Maternal Tdap Immunization in Guatemala

NCT02301702 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they are fully vaccinated because maternal antibodies may cross the placenta and passively protect her infant. The proposed study is a randomized, blinded, controlled, vaccine trial of maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36 weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa. Enrolled women and their infants will be followed up until 7 months post-partum.

Timeline

Start
2016-07
Primary completion
2019-08-13
Completion
2019-08-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Td Vaccine — —
Subject Tdap Vaccine 0.5 ml Intramuscular

Indications