Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India

NCT03554213 | Completed

• 2 other identifiers: IRB-39627OPP1169264
• Study Type: observational
• Target: 17,292
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Enteric Fever; Typhoid Fever; Salmonella Typhi Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adverse events following immunization

  up to 4 months

• vaccination coverage

  up to 18 months

• environmental water contamination with Salmonella Typhi

  up to 24 months

• seroconversion associated with typhoid infection

  up to 24 months

• cost-effectiveness of typhoid conjugate vaccination campaign

  up to 24 months

Study Arms (2)

Phase 1: TCV in 2018

Children receiving TCV (typhoid conjugate vaccine) in 2018 vaccination campaign by NMMC.

Biological: Typhoid Conjugate Vaccine

Phase 2: TCV in 2019

Children receiving TCV (typhoid conjugate vaccine) in 2019 vaccination campaign by NMMC.

Biological: Typhoid Conjugate Vaccine

Interventions

Typhoid Conjugate Vaccine BIOLOGICAL

Typbar TCV Vi-TT (Vi capsular polysaccharide conjugated with tetanus toxoid protein) manufactured by Bharat Biotech International Limited

Phase 1: TCV in 2018; Phase 2: TCV in 2019

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The focus of this study is children age 6 months to 16 years living in areas governed by Navi Mumbai Municipal Corporation (NMMC). The age range of children eligible to receive typhoid conjugate vaccine (TCV) in NMMC's TCV introduction program is 9 months to 15 years. For community surveys, only households with children \<16 years old will be selected. The evaluation study will examine a slightly broader age range than NMMC's TCV vaccination program because TCV is licensed for \>6 month old children and because the vaccine introduction will occur over 1 year thus the oldest eligible children will be 16 years old at study end.

You may qualify if:

• For overall study,
• For hospital-based surveillance, children age 6 months to 16 years.
• For community-based surveys, adult members of households with children \<16 years old.
• 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.

You may not qualify if:

• For all study components,
• Already enrolled in same study component.
• No informed consent or assent given.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• Centers for Disease Control and Prevention: collaborator
• World Health Organization: collaborator
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (6)

D. Y. Patil Medical College and Hospital, Nerul

Navi Mumbai, India

Location

Dr. Joshi's Central Clinical Microbiology Laboratory, Vashi

Navi Mumbai, India

Location

Dr. Yewale Multispecialty Hospital for Children, Vashi

Navi Mumbai, India

Location

Mahatma Gandhi Memorial (MGM) New Bombay Hospital, Vashi

Navi Mumbai, India

Location

Mathadi Hospital Trust, Koparkharaine

Navi Mumbai, India

Location

Navi Mumbai Municipal Corporation (NMMC) General Hospital, First Referral Unit (FRU), Vashi

Navi Mumbai, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

* In the hospital surveillance component, blood cultures will be collected and tested for Salmonella Typhi and Paratyphi. Purified bacterial isolates of Salmonella Typhi and Paratyphi will be tested for antimicrobial resistance and stored for possible future genetic/genomic testing of the bacterial DNA. * In a subset of the community surveillance component, dried blood spots will be collected onto filter paper and stored to test for antibodies against typhoid.

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Stephen Luby, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kashmira Date, MD MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Shanta Dutta, MD PhD

  National Institute of Cholera and Enteric Diseases (NICED)

  PRINCIPAL INVESTIGATOR

• Pankaj Bhatnagar, MD

  World Health Organization (WHO) - India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: July 2, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

IN (6)