Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediarix TM, Infanrix penta TM | Biological | The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-PT, anti-FHA and anti-PRN antibody titers. | One month after the 3rd dose of the primary vaccination course | |
| Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers | One month after the 3rd dose of the primary vaccination course | |
| Anti-HBs antibody titers | One month after the 3rd dose of the primary vaccination course | |
| Anti-polio virus types 1, 2 and 3 antibody titers | One month after the 3rd dose of the primary vaccination course | |
| Anti-PRP antibody titers | One month after the 3rd dose of the primary vaccination course |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events | During the 4-day follow-up period after each dose | |
| Occurrence of unsolicited adverse events | During the 30-day follow-up period after each dose | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21621155 | Background | Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8. |
| 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 |
|---|---|---|---|
| 217744/049 | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hiberix TM | Biological | The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age. |
|
| Occurrence of Serious Adverse Events |
| Over the course of the study |
For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/049 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/049 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/049 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 217744/049 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003015 | Clostridium Infections |