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The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrixâ„¢-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrixâ„¢-HepB/Hiberixâ„¢ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitecâ„¢), given concomitantly with Tritanrixâ„¢-HepB/Hiberixâ„¢ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.
Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrixâ„¢-HBV (3 different groups) GSK Biologicals' Tritanrixâ„¢-HBV/Hiberixâ„¢ GSK Biologicals' Tritanrixâ„¢-HBV/Hiberixâ„¢ +Meningitecâ„¢
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPw-HBV/Hib-MenAC conjugate vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects). |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited events (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study). Pre-dose 1, antibody levels to Men(A&C) & PRP; & in some subjects anti-BPT antibody levels Seropositivity/seroprotection/vaccine response & antibody levels |
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Inclusion criteria:
• Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.
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 |
|---|---|---|---|
| 17716936 | Derived | Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. doi: 10.1016/j.ijid.2007.06.002. Epub 2007 Aug 22. |
| Label | URL |
|---|---|
| Booster studies | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 100480 | 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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| Khon Kaen |
| 40002 |
| Thailand |
| GSK Investigational Site | Songkhla | 90110 | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100480 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100480 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100480 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100480 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100480 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales 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 |
| D003015 | Clostridium Infections |
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