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To compare three formulations of Hib-MenAC vaccines mixed with Tritanrixâ„¢-HepB vaccine with that of Tritanrixâ„¢-HepB vaccine concomitantly administered with GSK Biologicals' Hiberixâ„¢ vaccine and Tritanrixâ„¢-HepB vaccine mixed with Hiberixâ„¢ vaccine and concomitantly administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitecâ„¢), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.
Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrixâ„¢-HepB (3 different groups) GSK Biologicals' Tritanrixâ„¢-HepB + GSK Biologicals' Hiberixâ„¢ GSK Biologicals' Tritanrixâ„¢-HepB mixed with GSK Biologicals' Hiberixâ„¢ + Wyeth Lederle's Meningitecâ„¢
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPw-HBV/Hib-MenAC conjugate vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis) | ||
| One month after the third dose, antibody concentrations or titres against all vaccine antigens |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manila | Philippines |
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| Reactogenicity & safety: after each dose: solicited (d 0-7, local & general) & unsolicited (d 0-30) symptoms |
| Over the full course of the study: serious adverse events (SAEs) |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| 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 |
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