Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India
Trial ID or NCT#
NCT03554213
Status
NOT RECRUITING
Purpose
The purpose of this study is to evaluate the impact of a government-led typhoid conjugate vaccine introduction program on typhoid disease burden in Navi Mumbai, India.
Official Title
Evaluation of a Typhoid Conjugate Vaccine Introduction Program in Navi Mumbai, India
Eligibility Criteria
Ages Eligible for Study: 6 Months to 16 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- For overall study, 1. For hospital-based surveillance, children age 6 months to 16 years. 2. For community-based surveys, adult members of households with children <16 years old. 3. Parental consent (and child assent for >12 years) given. For hospital-based surveillance for typhoid fever, additional criteria include: history of fever for >72 hours within the last 7 days without upper respiratory tract symptoms and vesicular rash; strong clinical suspicion of enteric fever including ileal perforations; or diagnosis of enteric fever confirmed by positive blood cultures or histopathology. For outpatients, additional criterion of living in areas governed by Navi Mumbai Municipal Corporation. For hospital-based surveillance of adverse events of special interest, timing will focus on one month prior to and 42 days after the vaccination campaign. Diagnoses included are: anaphylaxis, bronchospasm, urticaria, Guillain-Barré syndrome, meningitis, encephalitis, myelitis, seizures, thrombocytopenia, and sudden death. For all community surveys, additional criterion of living in areas governed by Navi Mumbai Municipal Corporation.
Exclusion Criteria:
- For all study components, 1. Already enrolled in same study component. 2. No informed consent or assent given. For hospital-based surveillance for typhoid fever, additional exclusion criteria are: fever <72 hours, symptoms of upper respiratory tract infection (coryza, rhinorrhea), and vesicular exanthem. For outpatients, those living outside of NMMC-governed areas will be excluded. For community surveys, households without children <16 years old and households in which there is no adult (>18 years old) at time of survey will be excluded.
Investigator(s)
Stephen Luby
View on ClinicalTrials.gov