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The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrixâ„¢-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.
The study is double blind. However the active control vaccine Tritanrixâ„¢-HepB/Hiberixâ„¢ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hib-MenAC mixed with Tritanrixâ„¢-HepB | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs |
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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 | Bangkok | 10400 | Thailand | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31307216 | Derived | Guignard A, Haguinet F, Wery S, Kerdpanich P. Prevalence and Persistence of Maternal Dengue Neutralizing Antibodies in Infants From Central and Southern Thailand: A Retrospective Cohort Study. Asia Pac J Public Health. 2019 May;31(4):288-295. doi: 10.1177/1010539519853396. |
| 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 |
|---|---|---|---|
| 104733 | 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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| Khon Kaen |
| 40002 |
| Thailand |
| GSK Investigational Site | Songkhla | 90110 | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104733 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104733 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104733 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104733 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104733 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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