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Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.
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This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2202083A GROUP | Experimental | Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
|
| INFANRIX + MENJUGATE GROUP | Active Comparator | Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2202083A vaccine | Biological | Intramuscular, three doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL | As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done. | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination. |
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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 axillary temperature >= 38.5 ºC 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bratislava | 841 08 | Slovakia | |||
| 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 |
|---|---|---|---|
| 111761 | Individual Participant Data Set | 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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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2202083A Group | Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
| FG001 | Infanrix + Menjugate Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Infanrix hexa |
| Biological |
Intramuscular, three doses |
|
| Menjugate | Biological | Intramuscular, two doses |
|
| During the 8-day (Days 0-7) post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination. | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses |
| Number of Subjects With Unsolicited Adverse Events AE(s) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Month 0 to Month 9) |
| Bratislava |
| 851 05 |
| Slovakia |
| GSK Investigational Site | Dolný Kubín | 026 01 | Slovakia |
| GSK Investigational Site | Dunajská Streda | 929 01 | Slovakia |
| GSK Investigational Site | Nové Zámky | 940 01 | Slovakia |
| GSK Investigational Site | Ružomberok | 034 01 | Slovakia |
| GSK Investigational Site | Štúrovo | 943 01 | Slovakia |
| GSK Investigational Site | Trnava | 917 01 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111761 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2202083A Group | Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
| BG001 | Infanrix + Menjugate Group | Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL | As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done. | Posted | At Month 3 |
|
| |||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses |
| |||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 8-day (Days 0-7) post-vaccination period following each dose and across doses |
| |||||||||||||||||||||
| Secondary | Number of Subjects With Unsolicited Adverse Events AE(s) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period |
| |||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Month 0 to Month 9) |
|
|
Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: Throughout the entire study period (from Month 0 up to Month 9).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2202083A Group | Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG001 | Infanrix + Menjugate Group | Subjects in this group were to receive three doses of Infanrix hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. | 0 | 7 | 0 | 7 | 5 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Redness | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Drowsiness | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Loss of appetite | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Temperature | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| 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 |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| 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 |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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