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This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine. |
|
| Group B | Active Comparator | Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPa-HBV-IPV/Hib (Infanrix hexa™) | Biological | Three doses administered intramuscularly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value | One month after the 2nd dose of the primary vaccination course ( Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | |
| Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects |
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Inclusion Criteria:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001. | ||
| 15370670 | Background | Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572. | |
| 22349525 |
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| DTPa-HBV-IPV (Infanrix penta™) |
| Biological |
Three doses administered intramuscularly |
|
| Hib (Hiberix™) | Biological | Three doses administered intramuscularly |
|
| One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) |
| Immunogenicity with respect to the components of the study vaccines in terms of antibody titres | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) |
| Immunogenicity with respect to the components of the study vaccines in terms of vaccine response | One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) |
| Occurrence of solicited local symptoms | Within 4 days after each vaccination and overall |
| Occurrence of solicited general symptoms | Within 4 days after each vaccination and overall |
| Occurrence of unsolicited symptoms | Within 30 days after each vaccination and overall |
| Occurrence of serious adverse events | Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) |
| Derived |
| Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18. |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D004165 | Diphtheria |
| D006192 | Haemophilus Infections |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C514867 | Hiberix |
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