Epidemiology of Rotavirus Infection in North India Community

NCT01508533 | Completed

• 1 other identifier: SAS/BBIL/07/2008
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.

Conditions

Rotavirus Gastroenteritis

Keywords

Disease burden; Rotavirus gastroenteritis

Outcome Measures

Primary Outcomes (4)

• Disease burden

  All episodes of gastroenteritis: * rotavirus gastroenteritis * rotavirus gastroenteritis by the G and P types * severe gastroenteritis * severe rotavirus gastroenteritis * severity score of all episodes of gastroenteritis Rates of hospitalization in the above categories Proportion requiring rehydration therapy in all the above categories

  1 year

• Duration of rotavirus shedding

  To ascertain the duration of rotavirus shedding after an episode of rotavirus gastroenteritis

  1 year

• Rotavirus genotypes

  To identify genotypes of rotavirus

  1 year

• Data collection for planning and implementation of phase III trials

  To collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.

  1 year

Study Arms (2)

Cohort 1

Cohort 1: Infants enrolled at ≤1 week and followed up weekly till one year of age.

Cohort 2

Cohort 2: Infants enrolled at 12 months and followed up weekly till they are aged 24 months.

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study was conducted in Delhi at Govindpuri-Tigri-Dakshinpuri, Tuglakabad and Sangam Vihar.

You may qualify if:

• Parents/guardian consent for participation and are able to understand study procedures
• Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
• Absence of any illness requiring hospitalization
• No confirmed plans to move in the next 12 months

You may not qualify if:

• Participating in any other trial
• Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
• Known case of immunodeficiency disease, known HIV positive
• Known case of chronic gastrointestinal disease

Sponsors & Collaborators

• Society for Applied Studies: lead
• National Institute of Immunology, New Delhi: collaborator
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Study Officials

• Nita Bhandari, PhD

  Society for Applied Studies

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

IN (1)