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Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India
Not Recruiting
Trial ID: NCT03554213
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
Stanford Investigator(s)
Eligibility
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.
Intervention(s):
biological: Typhoid Conjugate Vaccine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305