Infections, Rotavirus Clinical Trial
Official title:
A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country. ;
| 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 |
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 | |
| Completed |
NCT00653198 -
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
|
N/A |