Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026779
Other study ID # HCH-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2009
Est. completion date November 1, 2019

Study information

Verified date November 2019
Source Lifespan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 803
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 5 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Hasbro Children's Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Lifespan Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions 2007-2009
Secondary Vaccine use outside the recommended age limits 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 2007-2009
Secondary Risk factors for non-receipt of rotavirus vaccine Identification of risk factors for non-receipt of rotavirus vaccine 2007-2009
Secondary Characterize the strains of rotavirus circulating in the community Characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine 2002-2009
Secondary Assess rotavirus vaccine coverage Assess rotavirus vaccine coverage in Rhode Island 2007-2009
See also
  Status Clinical Trial Phase
Completed NCT01575197 - Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana Phase 4
Completed NCT01202201 - A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan N/A
Completed NCT00953056 - A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) Phase 1
Completed NCT00737503 - Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab Phase 4
Completed NCT04185545 - Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates Phase 3
Completed NCT03474055 - Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India Phase 2/Phase 3
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Completed NCT00489567 - Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden N/A
Completed NCT02584816 - Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization Phase 3
Completed NCT02062385 - Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) Phase 3
Completed NCT02133690 - A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants Phase 3
Completed NCT01177657 - Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil N/A
Completed NCT00740935 - Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. Phase 4
Completed NCT01265355 - Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement Phase 2/Phase 3
Completed NCT00169455 - Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants Phase 3
Completed NCT04819412 - To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus Phase 3
Completed NCT02728869 - Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants Phase 1/Phase 2
Recruiting NCT05958771 - The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E Phase 3
Recruiting NCT01061658 - Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine Phase 1/Phase 2
Completed NCT01508533 - Epidemiology of Rotavirus Infection in North India Community N/A