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The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemophilus influenzae type b- and meningococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128 | ||
| Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3 | ||
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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 | Alcorcón | 28922 | Spain | |||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| 102547 | 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.
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| Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc. |
| SAEs for whole study |
| Almeira |
| 4009 |
| Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08950 | Spain |
| GSK Investigational Site | Basurto/Bilbao | 48013 | Spain |
| GSK Investigational Site | Burgos | 09005 | Spain |
| GSK Investigational Site | Getafe | 28905 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Móstoles/Madrid | 28935 | Spain |
| GSK Investigational Site | Palma de Mallorca | 07014 | Spain |
| GSK Investigational Site | Valladolid | 47010 | Spain |
| GSK Investigational Site | Vélez-Málaga | Spain |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102547 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102547 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102547 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102547 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102547 | Study Protocol | 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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