Trial Search Results

Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Bill and Melinda Gates Foundation

Stanford Investigator(s):

Intervention(s):

  • Biological: Typhoid Conjugate Vaccine

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.

Ages Eligible for Study

6 Months - 16 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting