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To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)
All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemophilus Influenza type b vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| - Occurrence of solicited symptoms during the specific follow up period after vaccination. | ||
| - Occurrence of unsolicited symptoms during the specific follow up period after vaccination. | ||
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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 | Nanning | Guangxi | 530021 | China |
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| ID | Term |
|---|---|
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
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| - Occurrence of serious adverse events during the study period. |