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The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrixâ„¢-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrixâ„¢-HepB/Hiberixâ„¢ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrixâ„¢ HepB/Hib-MenAC at 6, 10 & 14 weeks age.
Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrixâ„¢-HepB/Hib-MenAC and hepatitis B vaccine at birth
- GSK Biologicals' Tritanrixâ„¢-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrixâ„¢-HepB/Hiberixâ„¢ There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive: - GSK Biologicals' Tritanrixâ„¢-HepB/Hib-MenAC and hepatitis B vaccine at birth
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPw-HBV/Hib-MenAC conjugate vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: One month post-dose 3, measurement of serum bactericidal titers against meningococcal serogroups A & C (SBA-MenA; SBA-MenC), anti-PRP, anti-HBs & anti-diphtheria concentrations; & in some subjects anti-tetanus & anti-BPT concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity and safety: After each vaccination, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (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 | Manila | 1000 | Philippines | |||
| 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 |
|---|---|---|---|
| 100478 | 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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| Quezon City |
| 1109 |
| Philippines |
| GSK Investigational Site | Sampaloc, Manila | 1008 | Philippines |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100478 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100478 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100478 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100478 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100478 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| D006509 | Hepatitis B |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales 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 |
| D003015 | Clostridium Infections |
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