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Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
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The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age. |
|
| Group B | Active Comparator | Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 251154 vaccine | Biological | Intramuscular, single dose |
| |
| Infanrix hexa™ |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines. | One month after the first dose of primary vaccination. | |
| Immunogenicity with respect to components of the study vaccines. | One month after the third dose of primary vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). | One month after the second dose of primary vaccination. | |
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). | One month after the third dose of primary vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
• Current febrile illness or temperature >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C547294 | PHiD-CV vaccine |
| C492457 | RIX4414 vaccine |
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| Biological |
Intramuscular, four doses |
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| Synflorix™ | Biological | Intramuscular, four doses |
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| Rotarix™ | Biological | Oral, two doses |
|
| Immunogenicity with respect to components of the study vaccines (on secondary readouts). | One month after booster vaccination. |
| Occurrence of solicited local and general symptoms (on secondary readouts). | On Day 0-Day 7 after neonatal vaccination. |
| Occurrence of solicited local and general symptoms (on secondary readouts). | On Day 0-Day 3 after each dose of primary and booster vaccination. |
| Occurrence of unsolicited adverse events (on secondary readouts). | On Day 0-Day 30 after each vaccination. |
| Occurrence of serious adverse events (on secondary readouts). | From enrolment up to study end. |