Typhoid Fever Clinical Trial
Official title:
Evaluation of a Typhoid Conjugate Vaccine Introduction Program in Navi Mumbai, India
Verified date | September 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 17292 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 16 Years |
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. |
Country | Name | City | State |
---|---|---|---|
India | D. Y. Patil Medical College and Hospital, Nerul | Navi Mumbai | |
India | Dr. Joshi's Central Clinical Microbiology Laboratory, Vashi | Navi Mumbai | |
India | Dr. Yewale Multispecialty Hospital for Children, Vashi | Navi Mumbai | |
India | Mahatma Gandhi Memorial (MGM) New Bombay Hospital, Vashi | Navi Mumbai | |
India | Mathadi Hospital Trust, Koparkharaine | Navi Mumbai | |
India | Navi Mumbai Municipal Corporation (NMMC) General Hospital, First Referral Unit (FRU), Vashi | Navi Mumbai |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, National Institute of Cholera and Enteric Diseases, India, World Health Organization |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood culture-confirmed typhoid fever | Hospital surveillance for typhoid fever diagnosed by blood cultures will be conducted at 6 study sites in Navi Mumbai: 5 hospitals and 1 independent laboratory. | up to 24 months | |
Secondary | Adverse events following immunization | Evaluation of safety and adverse events following immunization (AEFI) during Phase I of TCV introduction in 2018. Three safety evaluations include: 1) routine national AEFI surveillance system reports, 2) active follow-up by phone of a subset of vaccine recipients at 48hrs and 7 days post vaccination, and 3) hospital-based surveillance at 5 hospital study sites conducting typhoid fever surveillance examining patient records for adverse events of special interest in both vaccinated and unvaccinated populations | up to 4 months | |
Secondary | vaccination coverage | Community surveys estimating TCV coverage achieved by the vaccination campaign in the public sector during phase 1 (and potentially phase 2 if funding allows) as well as vaccine acceptability, refusals, knowledge, attitudes, and social mobilization strategies. | up to 18 months | |
Secondary | environmental water contamination with Salmonella Typhi | Molecular testing of household and municipal water samples for presence of Salmonella Typhi and Paratyphi A and impact of TCV vaccination program on water contamination. | up to 24 months | |
Secondary | seroconversion associated with typhoid infection | Collect dried blood spots in subset of household surveys and store for future testing of antibodies associated with typhoid infection (once other research studies on best antibody tests have resulted). | up to 24 months | |
Secondary | cost-effectiveness of typhoid conjugate vaccination campaign | Plan to develop a tool and to estimate the delivery cost of TCV, to estimate the cost of illness (COI) related to typhoid fever, and ultimately to estimate the cost-effectiveness of typhoid conjugate vaccination campaign conducted in Navi Mumbai. | up to 24 months | |
Secondary | clinical syndromes of febrile illness | Community-based surveys of clinical syndromes of febrile illness and healthcare utilization in NMMC-governed areas (same as TCV vaccination areas). | up to 18 months |
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