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This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age.
The study has 3 groups.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 valent pneumococcal conjugate (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Post vacc: rectal fever >39°C |
| Measure | Description | Time Frame |
|---|---|---|
| AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Helsinki | 00930 | Finland | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20508478 | Background | Vesikari T, Karvonen A, Lindblad N, Korhonen T, Lommel P, Willems P, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with measles-mumps-rubella-varicella vaccine in children aged 12 to 16 months. Pediatr Infect Dis J. 2010 Jun;29(6):e47-56. doi: 10.1097/INF.0b013e3181dffabf. | |
| Background | Vesikari T et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) booster co-administered with MMRV vaccine in children aged 12-18 months. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010. | ||
| Background | Vesikari T et al. Immunogenicity and safety of a Measles-Mumps-Rubella-Varicella (MMRV) vaccine co-administered with pediatric vaccines in children aged 11-14 months. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008. |
| 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 |
|---|---|---|---|
| 107706 | Individual Participant Data Set | 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.
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| Jarvenpaa |
| 04400 |
| Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Tampere | 33100 | 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 |
| 107706 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107706 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107706 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107706 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107706 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C586648 | 10-valent pneumococcal conjugate vaccine |
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