Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-dose oral live attenuated G1P[8] human rotavirus vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Espoo | 02100 | Finland | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21238572 | Derived | Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011 Mar 3;29(11):2079-84. doi: 10.1016/j.vaccine.2011.01.004. Epub 2011 Jan 14. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107876 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Helsinki |
| 00100 |
| Finland |
| GSK Investigational Site | Helsinki | 00930 | Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kotka | 48600 | Finland |
| GSK Investigational Site | Lahti | 15140 | Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
| GSK Investigational Site | Vantaa | 01600 | Finland |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107876 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107876 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107876 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107876 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107876 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided