Infections, Rotavirus Clinical Trial
Official title:
Drug Use Investigation for ROTARIX
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix). ;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01435967 -
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
|
N/A | |
| Completed |
NCT00370318 -
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
|
Phase 3 | |
| Completed |
NCT00345956 -
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
|
Phase 3 | |
| Completed |
NCT00140686 -
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
|
Phase 3 | |
| Completed |
NCT00383903 -
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
|
Phase 2 | |
| Completed |
NCT00750893 -
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
|
||
| Completed |
NCT00533507 -
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age
|
Phase 3 | |
| Completed |
NCT00363545 -
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
|
Phase 3 | |
| Completed |
NCT02914184 -
Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
|
Phase 3 | |
| Completed |
NCT00489567 -
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
|
N/A | |
| Completed |
NCT01733862 -
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
|
||
| Completed |
NCT00779779 -
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
|
||
| Completed |
NCT00382772 -
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
|
Phase 3 | |
| Completed |
NCT00729001 -
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
|
Phase 2 | |
| Completed |
NCT00353366 -
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
|
||
| Completed |
NCT01198769 -
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
|
Phase 4 | |
| Completed |
NCT00385320 -
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
|
Phase 2 | |
| Completed |
NCT00432380 -
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
|
Phase 2 | |
| Completed |
NCT01563159 -
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011
|
N/A | |
| Completed |
NCT01339221 -
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
|
N/A |