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
Not provided
Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeMuRu-OKA (study vac) | Biological | |||
| MMR, Varicella vacc (control) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella, MMR titres at 42-56 days after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) |
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 | Edmonton | Alberta | T5N 4A3 | Canada | ||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| 105909 | Clinical Study Report | 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
| Vancouver |
| British Columbia |
| V6H 3N1 |
| Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Enna | Sicily | 94015 | Italy |
| GSK Investigational Site | Ragusa | Sicily | 97100 | Italy |
| GSK Investigational Site | San Gregorio Di Catania (CT) | Sicily | 95027 | Italy |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105909 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105909 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105909 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105909 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105909 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D009107 | Mumps |
| D012409 | Rubella |
| D008457 | Measles |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D018185 | Morbillivirus Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
Not provided
Not provided