Epidemiology of Rotavirus Infection in North India Community

This study has been completed.
Sponsor:
Collaborators:
National Institute of Immunology, New Delhi
Ministry of Science and Technology, India
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT01508533
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition
Rotavirus Gastroenteritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disease Burden Study and Site Preparation for Planning and Implementation of the Phase III Trials for the Oral Rotavirus Vaccine 116E

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • Disease burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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


  • Duration of rotavirus shedding [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To ascertain the duration of rotavirus shedding after an episode of rotavirus gastroenteritis

  • Rotavirus genotypes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To identify genotypes of rotavirus

  • Data collection for planning and implementation of phase III trials [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for participation through criteria for inclusion and exclusion in the trial were enrolled. Two cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and followed up till 24 months of age (cohort 2=100).

Weekly contact were made by field workers for both the cohorts. At each contact cases of gastroenteritis were identified. All infants with gastroenteritis were assessed by a field worker/clinical coordinator. The child was assessed for presence of dehydration, danger signs. The field worker/clinical coordinator ensured that at least one diarrheal stool specimen was collected for each episode of gastroenteritis. Infants were treated at the study clinic or escorted to one of the identified hospitals, if required.

Caregivers of the enrolled infants were explained the signs and symptoms of suspected intussusception, dehydration and danger signs that require hospital referral and were given the option to seek care from the study clinic or from one of the identified hospitals in the vicinity.

Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who were identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were collected in order to assess duration of shedding of rotavirus during a natural infection.

The study was also designed 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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508533

Locations
India
Society for Applied Studies
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Society for Applied Studies
National Institute of Immunology, New Delhi
Ministry of Science and Technology, India
Investigators
Principal Investigator: Nita Bhandari, PhD Society for Applied Studies
  More Information

No publications provided

Responsible Party: NBhandari, Joint Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01508533     History of Changes
Other Study ID Numbers: SAS/BBIL/07/2008
Study First Received: January 9, 2012
Last Updated: January 9, 2012
Health Authority: India: Ministry of Science and Technology

Keywords provided by Society for Applied Studies:
Disease burden
Rotavirus gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014