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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001544-11 | EudraCT Number |
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This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLACEBO-ROTARIX-ROTARIX GROUP | Experimental | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
|
| ROTARIX-PLACEBO-ROTARIX GROUP | Experimental | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
|
| PLACEBO GROUP | Placebo Comparator | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarixâ„¢ | Biological | oral doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody | Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group. | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-RV IgA Antibody | Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group. |
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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 | City of Muntinlupa | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21256876 | Background | Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21. |
| 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 |
|---|---|---|---|
| 109216 | Informed Consent Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Rotarix-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| FG001 | Rotarix-Placebo-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| FG002 | Placebo Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-Rotarix-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| 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 Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody | Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points. | Posted | Number | Subjects | At Month 3 |
|
Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
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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 | Placebo-Rotarix-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Milk allergy | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough/runny nose | General disorders | MedDRA 10.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Placebo | Biological | oral dose |
|
| At Month 3 |
| Serum IgA Antibody Concentrations Against Rotavirus | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups. | At Month 3 |
| Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea | Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day. | During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination. | During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses |
| Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes | Presence of RV (vaccine strain or wild-type) in GE stools. | From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3 |
| Number of Subjects Reporting Any Unsolicited Adverse Event (AE) | 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. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | During the 31-day (Days 0-30) period following any study vaccine dose or placebo |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (from Day 0 to Month 3) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109216 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 | Rotarix-Placebo-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| BG002 | Placebo Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. |
| BG003 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|
| Secondary | Number of Seroconverted Subjects for Anti-RV IgA Antibody | Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group. | The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points. | Posted | Number | Subjects | At Month 3 |
|
|
|
| Secondary | Serum IgA Antibody Concentrations Against Rotavirus | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups. | The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarixâ„¢ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | At Month 3 |
|
|
|
| Secondary | Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea | Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day. | The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented. | Posted | Number | Subjects | During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination. | The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented. | Posted | Number | Subjects | During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses |
|
|
|
| Secondary | Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes | Presence of RV (vaccine strain or wild-type) in GE stools. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented. | Posted | Number | Subjects | From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3 |
|
|
|
| Secondary | Number of Subjects Reporting Any Unsolicited Adverse Event (AE) | 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. 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 with at least one study vaccine/placebo administration documented. | Posted | Number | Subjects | During the 31-day (Days 0-30) period following any study vaccine dose or placebo |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires 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 with at least one study vaccine/placebo administration documented. | Posted | Number | Subjects | During the entire study period (from Day 0 to Month 3) |
|
|
|
| 1 |
| 150 |
| 139 |
| 150 |
| EG001 | Rotarix-Placebo-Rotarix Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarixâ„¢ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. | 1 | 150 | 137 | 150 |
| EG002 | Placebo Group | Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines. | 1 | 75 | 69 | 75 |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhea | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fever (Rectally) | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Loss of appetite | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhea infectious | Infections and infestations | MedDRA 10.1 | 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.
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
|
| Any symptom, Dose 3 [N= 146, 147, 75] |
|
| Any symptom, Across doses [N= 150, 150, 75] |
|
|
| Related Cough/ runny nose, D1 [N=150, 150, 75] |
|
| Any Diarrhea, D1 [N=150, 150, 75] |
|
| Grade 3 Diarrhea, D1 [N=150, 150, 75] |
|
| Related Diarrhea, D1 [N=150, 150, 75] |
|
| Any Fever, D1 [N=150, 150, 75] |
|
| Grade 3 Fever, D1 [N=150, 150, 75] |
|
| Related Fever, D1 [N=150, 150, 75] |
|
| Any Irritability, D1 [N=150, 150, 75] |
|
| Grade 3 Irritability, D1 [N=150, 150, 75] |
|
| Related Irritability, D1 [N=150, 150, 75] |
|
| Any Loss of appetite, D1 [N=150, 150, 75] |
|
| Grade 3 Loss of appetite, D1 [N=150, 150, 75] |
|
| Related Loss of appetite, D1 [N=150, 150, 75] |
|
| Any Vomiting, D1 [N=150, 150, 75] |
|
| Grade 3 Vomiting, D1 [N=150, 150, 75] |
|
| Related Vomiting, D1 [N=150, 150, 75] |
|
| Any Cough/ runny nose, D2 [N=149, 147, 75] |
|
| Grade 3 Cough/ runny nose, D2 [N=149, 147, 75] |
|
| Related Cough/ runny nose, D2 [N=149, 147, 75] |
|
| Any Diarrhea, D2 [N=149, 147, 75] |
|
| Grade 3 Diarrhea, D2 [N=149, 147, 75] |
|
| Related Diarrhea, D2 [N=149, 147, 75] |
|
| Any Fever, D2 [N=149, 147, 75] |
|
| Grade 3 Fever, D2 [N=149, 147, 75] |
|
| Related Fever, D2 [N=149, 147, 75] |
|
| Any Irritability, D2 [N=149, 147, 75] |
|
| Grade 3 Irritability, D2 [N=149, 147, 75] |
|
| Related Irritability, D2 [N=149, 147, 75] |
|
| Any Loss of appetite, D2 [N=149, 147, 75] |
|
| Grade 3 Loss of appetite, D2 [N=149, 147, 75] |
|
| Related Loss of appetite, D2 [N=149, 147, 75] |
|
| Any Vomiting, D2 [N=149, 147, 75] |
|
| Grade 3 Vomiting, D2 [N=149, 147, 75] |
|
| Related Vomiting, D2 [N=149, 147, 75] |
|
| Any Cough/ runny nose, D3 [N=146, 147, 75] |
|
| Grade 3 Cough/ runny nose, D3 [N=146, 147, 75] |
|
| Related Cough/ runny nose, D3 [N=146, 147, 75] |
|
| Any Diarrhea, D3 [N=146, 147, 75] |
|
| Grade 3 Diarrhea, D3 [N=146, 147, 75] |
|
| Related Diarrhea, D3 [N=146, 147, 75] |
|
| Any Fever, D3 [N=146, 147, 75] |
|
| Grade 3 Fever, D3 [N=146, 147, 75] |
|
| Related Fever, D3 [N=146, 147, 75] |
|
| Any Irritability, D3 [N=146, 147, 75] |
|
| Grade 3 Irritability, D3 [N=146, 147, 75] |
|
| Related Irritability, D3 [N=146, 147, 75] |
|
| Any Loss of appetite, D3 [N=146, 147, 75] |
|
| Grade 3 Loss of appetite, D3 [N=146, 147, 75] |
|
| Related Loss of appetite, D3 [N=146, 147, 75] |
|
| Any Vomiting, D3 [N=146, 147, 75] |
|
| Grade 3 Vomiting, D3 [N=146, 147, 75] |
|
| Related Vomiting, D3 [N=146, 147, 75] |
|
| Any Cough/runny nose, Across [N=150, 150, 75] |
|
| Grade 3 Cough/runny nose, Across [N=150, 150, 75] |
|
| Related Cough/runny nose, Across [N=150, 150, 75] |
|
| Any Diarrhea, Across [N=150, 150, 75] |
|
| Grade 3 Diarrhea, Across [N=150, 150, 75] |
|
| Related Diarrhea, Across [N=150, 150, 75] |
|
| Any Temperature, Across [N=150, 150, 75] |
|
| Grade 3 Temperature, Across [N=150, 150, 75] |
|
| Related Temperature, Across [N=150, 150, 75] |
|
| Any Irritability, Across [N=150, 150, 75] |
|
| Grade 3 Irritability, Across [N=150, 150, 75] |
|
| Related Irritability, Across [N=150, 150, 75] |
|
| Any Loss of appetite, Across [N=150, 150, 75] |
|
| Grade 3 Loss of appetite, Across [N=150, 150, 75] |
|
| Related Loss of appetite, Across [N=150, 150, 75] |
|
| Any Vomiting, Across [N=150, 150, 75] |
|
| Grade 3 Vomiting, Across [N=150, 150, 75] |
|
| Related Vomiting, Across [N=150, 150, 75] |
|
|
| Between Dose 3 and Month 3 [N=146, 147, 75] |
|
| Between Dose 1 and Month 3 [N=150, 150, 75] |
|