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The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.
This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemophilus influenzae type b- and meningococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Any grade 3 solicited symptoms (d 0 - 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion |
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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 | Almería | 04007 | Spain | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19952860 | Background | Carmona A, Miranda M, Barrio F, De Vicente A, Mares J, Munoz E, Diez-Delgado J, Alonso A, Gimenez-Sanchez F, Merino J, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 103954 Study Group. Reactogenicity and immunogenicity of combined Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine booster dose coadministered with measles, mumps, and rubella vaccine. Pediatr Infect Dis J. 2010 Mar;29(3):269-71. doi: 10.1097/INF.0b013e3181c15977. |
| 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 |
|---|---|---|---|
| 103954 | 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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| Almería |
| 04009 |
| Spain |
| GSK Investigational Site | Antequera/Málaga | 29200 | Spain |
| GSK Investigational Site | Aravaca | 28023 | Spain |
| GSK Investigational Site | Blanes | Spain |
| GSK Investigational Site | Burgos | 09005 | Spain |
| GSK Investigational Site | Lleida | 25006 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28035 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Mollet Del Valles/Barcelona | 08100 | Spain |
| GSK Investigational Site | Pamplona | 31008 | Spain |
| GSK Investigational Site | Sant Adriá de Beyós, Barcelona | 08930 | Spain |
| GSK Investigational Site | Sant Eugenia de Berga, Barcelona | 08519 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Vélez-Málaga | Spain |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103954 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103954 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103954 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103954 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103954 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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