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NCT Number: NCT01026779

Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.

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Key information

Conditions

Rotavirus Gastroenteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

About this study

The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • rotavirus gastroenteritis requiring hospitalization
  • immunocompetent
  • born after April 15, 2006
  • greater than 2 months of age on the day of admission

Exclusion criteria

  • rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
  • an immunization record cannot be obtained through the KIDSNET database

Treatment and study plan

Primary outcomes

  1. Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations

    Time frame: 2007-2009

    Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions

Secondary outcomes

  1. Vaccine use outside the recommended age limits

    Time frame: 2007-2009

    The extent to which rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island

  2. Risk factors for non-receipt of rotavirus vaccine

    Time frame: 2007-2009

    Identification of risk factors for non-receipt of rotavirus vaccine

  3. Characterize the strains of rotavirus circulating in the community

    Time frame: 2002-2009

    Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine

  4. Assess rotavirus vaccine coverage

    Time frame: 2007-2009

    Assess rotavirus vaccine coverage in Rhode Island

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2009
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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