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Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India
Trial ID: NCT03554213
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.
Evaluation of a Typhoid Conjugate Vaccine Introduction Program in Navi Mumbai, India
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
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
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
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.
biological: Typhoid Conjugate Vaccine
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