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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005881-38 | EudraCT Number |
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This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Priorix-Tetra new WS Group | Experimental | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
|
| Priorix-Tetra current WS Group | Experimental | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) | Biological | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively. | At 42-56 days after the first dose of study vaccine (Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. | At 42-56 days after the second dose of study vaccine (Week 18) |
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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 | Singapore | 119074 | Singapore | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23425607 | Background | Huang LM, Lee BW, Chan PC, Povey M, Henry O. Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: a phase II, randomized, double-blind trial. Hum Vaccin Immunother. 2013 Jun;9(6):1308-15. doi: 10.4161/hv.24035. Epub 2013 Feb 20. |
| 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 |
|---|---|---|---|
| 108760 | Clinical Study Report | View IPD |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Out of the 501 enrolled participants, 3 were not administered any vaccine and hence were not considered as having started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Priorix-Tetra New WS Group | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
| FG001 | Priorix-Tetra Current WS Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK Biologicals' 208136, new formulation | Biological | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
|
| Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals. | At 42-56 days after the first and second dose of study vaccine(s). |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless 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. | Within 4 days after each vaccination (Days 0-3) |
| Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities. | Within 43 days (Days 0-42) after each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination. | Within 43 days (Days 0-42) after each vaccination |
| Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination. | Within 43 days (Days 0-42) after each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination. | Within 43 days (Days 0-42) after first vaccination dose |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination. | Within 43 days (Days 86-128) after second vaccination dose |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject. | From first study dose (Day 0) until study end (Week 18) |
| Singapore |
| 228510 |
| Singapore |
| GSK Investigational Site | Singapore | 229899 | Singapore |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 104 | Taiwan |
| GSK Investigational Site | Taipei | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108760 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108760 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108760 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108760 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108760 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Priorix-Tetra New WS Group | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
| BG001 | Priorix-Tetra Current WS Group | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. |
| 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 | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively. | The According-to-protocol (ATP) cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received vaccine according to their random assignment, who had not received a vaccine forbidden in the protocol and for whom pre/ post-vaccination serology results were available. | Posted | Count of Participants | Participants | At 42-56 days after the first dose of study vaccine (Week 6) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. | The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available. | Posted | Count of Participants | Participants | At 42-56 days after the second dose of study vaccine (Week 18) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals. | The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available. | Posted | Geometric Mean | 95% Confidence Interval | Titres | At 42-56 days after the first and second dose of study vaccine(s). |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless 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. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in. | Posted | Count of Participants | Participants | Within 4 days after each vaccination (Days 0-3) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects,with the symptom sheet filled-in. | Posted | Count of Participants | Participants | Within 43 days (Days 0-42) after each vaccination |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in. | Posted | Count of Participants | Participants | Within 43 days (Days 0-42) after each vaccination |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in. | Posted | Count of Participants | Participants | Within 43 days (Days 0-42) after each vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 43 days (Days 0-42) after first vaccination dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 43 days (Days 86-128) after second vaccination dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From first study dose (Day 0) until study end (Week 18) |
|
|
Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period.
The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Priorix-Tetra New WS Group | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. | 0 | 332 | 27 | 332 | 246 | 332 |
| EG001 | Priorix-Tetra Current WS Group | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. | 0 | 166 | 12 | 166 | 117 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Band neutrophil count increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Testicular retraction | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Encephalitis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea; Dose 1 | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough; Dose 1 | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough; Dose 2 | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea; Dose 2 | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain; Dose 1 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Redness; Dose 1 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling; Dose 1 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain; Dose 2 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Redness; Dose 2 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling; Dose 2 | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea; Dose 1 | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash; Dose 1 | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash; Dose 2 | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fever; Dose 1 | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Fever; Dose 2 | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection; Dose 1 | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection; Dose 2 | Infections and infestations | MedDRA 14.0 | 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 |
|---|---|
| D008457 | Measles |
| D002644 | Chickenpox |
| D009107 | Mumps |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
Not provided
Not provided
| Male |
|
| Asian - South East Asian heritage |
|
| White - Caucasian / European heritage |
|
| Unspecified |
|
| Anti-rubella ≥ 4 IU/mL |
|
| IgG varicella antibodies ≥ 1:4 dilution |
|
| Difference in percentage |
| -0.74 |
| 2-Sided |
| 95 |
| -6.14 |
| 5.58 |
| Non-Inferiority |
Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [-10%] or higher. |
| Difference in percentage | -0.32 | 2-Sided | 95 | -1.78 | 2.08 | Non-Inferiority | Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [-10%] or higher. |
| Difference in percentage | 4.69 | 2-Sided | 95 | 0.72 | 10.34 | Non-Inferiority | Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [-10%] or higher. |
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