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The purpose of the study is as follows:
This study will be conducted in two stages:
At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age.
At 15 to 18 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrixâ„¢-HepB/Hib-MenAC or Tritanrixâ„¢-HepB/Hib2.5.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPw-HBV/Hib-MenAC conjugate vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre & 1M post-DTP booster (subset of subjects), antibody levels for all vaccine antigens. Retrospective serious adverse events (SAEs). Solicited (day 0-7), unsolicited events (day 0-30). SAEs (entire study) |
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Inclusion criteria:
• Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents.
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 | City of Muntinlupa | 1781 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17981067 | Background | Gatchalian S, Palestroque E, De Vleeschauwer I, Han HH, Poolman J, Schuerman L, Dobbelaere K, Boutriau D. The development of a new heptavalent diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C vaccine: a randomized dose-ranging trial of the conjugate vaccine components. Int J Infect Dis. 2008 May;12(3):278-88. doi: 10.1016/j.ijid.2007.08.007. Epub 2007 Nov 5. |
| 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 |
|---|---|---|---|
| 759346/002 | Dataset Specification | 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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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 759346/002 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 759346/002 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 759346/002 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 759346/002 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 759346/002 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial 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 |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |