Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Priorix-Tetra Group | Experimental | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
|
| Priorix/ Priorix-Tetra Group | Experimental | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. |
|
| Control Group | Active Comparator | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biological's investigational MMRV vaccine 208136 | Biological | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. | At 42 - 56 days after the second vaccination dose at week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. |
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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bangalore | 560034 | India | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26362659 | Derived | Lalwani S, Chatterjee S, Balasubramanian S, Bavdekar A, Mehta S, Datta S, Povey M, Henry O. Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial. BMJ Open. 2015 Sep 11;5(9):e007202. doi: 10.1136/bmjopen-2014-007202. |
| 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 |
|---|---|---|---|
| 109995 | Study Protocol | 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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Priorix-Tetra Group | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| FG001 | Priorix/ Priorix-Tetra Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. |
| FG002 | Control Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Priorix-Tetra Group | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| BG001 | Priorix/ Priorix-Tetra Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen. | Posted | Count of Participants | Participants | At 42 - 56 days after the second vaccination dose at week 30 |
|
Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Not provided
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 Group | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough; Dose 1 | Respiratory, thoracic and mediastinal disorders | MedDra 14.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D012409 | Rubella |
| D009107 | Mumps |
| D008457 | Measles |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Priorix™ | Biological | Subcutaneous injection |
|
| Varilrix™ | Biological | Subcutaneous injection |
|
| Approximately 42 to 56 days after the first vaccine dose at week 6 |
| Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs). | At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose |
| 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. | During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2) |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination. | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
| Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination. | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
| Number of Subjects Reporting Any, Grade 3 and Related Rash | Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
| Number of Subjects Reporting Any Unsolicited Adverse Event | An unsolicited Adverse Event (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 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. | Within 43-day (Days 0-42) after the first and second vaccination dose |
| 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, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. | From the first study dose up to study end (Month 0 to Month 7.5 approximately) |
| Chennai |
| India |
| GSK Investigational Site | Goā | 403202 | India |
| GSK Investigational Site | Kolkata | 700073 | India |
| GSK Investigational Site | Pune | 411 011 | India |
| GSK Investigational Site | Pune | India |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109995 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Father - serious health problem |
|
| Parents personal problem |
|
| Subject eliminated (other vaccine) |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
| BG002 | Control Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| OG001 | Priorix/ Priorix-Tetra Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. |
| OG002 | Control Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
|
|
|
| Secondary | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen. | Posted | Count of Participants | Participants | Approximately 42 to 56 days after the first vaccine dose at week 6 |
|
|
|
| Secondary | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose |
|
|
|
| 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 | During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom 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 | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever > 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 | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally 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 | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) |
|
|
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Event | An unsolicited Adverse Event (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 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 43-day (Days 0-42) after the first and second vaccination dose |
|
|
|
| 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, result in disability/incapacity or 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 the first study dose up to study end (Month 0 to Month 7.5 approximately) |
|
|
|
| 0 |
| 180 |
| 7 |
| 180 |
| 114 |
| 180 |
| EG001 | Priorix/ Priorix-Tetra Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. | 0 | 180 | 6 | 180 | 116 | 180 |
| EG002 | Control Group | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. | 0 | 90 | 0 | 90 | 55 | 90 |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Pain; Dose 1 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Redness; Dose 1 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Pain; Dose 2 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Redness; Dose 2 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Swelling; Dose 2 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Fever; Dose 1 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Fever; Dose 2 | General disorders | MedDra 14.0 | Non-systematic Assessment |
|
| Rhinitis; Dose 1 | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis; Dose 1 | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection; Dose 1 | Infections and infestations | MedDra 14.0 | Non-systematic Assessment |
|
| Rhinitis; Dose 2 | Infections and infestations | MedDra 14.0 | Non-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.
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018185 | Morbillivirus Infections |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| Anti-mumps ≥ 231 U/ML |
|
|
| Anti-rubella ≥ 4 IU/mL |
|
|
| IgG varicella antibodies ≥ 1:4 |
|
|
| Anti-mumps; Week 6 |
|
|
| Anti-rubella; Week 6 |
|
|
| IgG varicella antibodies; Week 6 |
|
|
| Anti-measles; Week 30 |
|
|
| Anti-mumps; Week 30 |
|
|
| Anti-rubella; Week 30 |
|
|
| IgG varicella antibodies; Week 30 |
|
|
| Grade 3 Pain; Dose 1 |
|
|
| Any Redness; Dose 1 |
|
|
| Grade 3 Redness; Dose 1 |
|
|
| Any Swelling; Dose 1 |
|
|
| Grade 3 Swelling; Dose 1 |
|
|
| Any Pain; Dose 2 |
|
|
| Grade 3 Pain; Dose 2 |
|
|
| Any Redness; Dose 2 |
|
|
| Grade 3 Redness; Dose 2 |
|
|
| Any Swelling; Dose 2 |
|
|
| Grade 3 Swelling; Dose 2 |
|
|
| Grade 3 Meningism; Dose 1 |
|
|
| Related Meningism; Dose 1 |
|
|
| Any Parotid gland swelling; Dose 1 |
|
|
| Grade 3 Parotid gland swelling; Dose 1 |
|
|
| Related Parotid gland swelling; Dose 1 |
|
|
| Any Meningism; Dose 2 |
|
|
| Grade 3 Meningism; Dose 2 |
|
|
| Related Meningism; Dose 2 |
|
|
| Any Parotid gland swelling; Dose 2 |
|
|
| Grade 3 Parotid gland swelling; Dose 2 |
|
|
| Related Parotid gland swelling; Dose 2 |
|
|
| Grade 3 temperature; Dose 1 |
|
|
| Related temperature; Dose 1 |
|
|
| Any temperature; Dose 2 |
|
|
| Grade 3 temperature; Dose 2 |
|
|
| Related temperature; Dose 2 |
|
|
| Grade 3 Rash; Dose 1 |
|
|
| Related Rash; Dose 1 |
|
|
| Any Rash; Dose 2 |
|
|
| Grade 3 Rash; Dose 2 |
|
|
| Related Rash; Dose 2 |
|
|
| Title | Measurements |
|---|---|
|