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