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This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrixâ„¢/Hib | Biological | |||
| Infanrix | Biological | |||
| Hiberix | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL). | At Month 3 |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) | A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL). | At Month 3 |
| Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | The vaccine response was defined as it follows:
| At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL | The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported. | At Month 3 |
| Concentrations for Anti-D and Anti-T Antibodies |
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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 | Mengshan | China | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104 |
| 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 |
|---|---|---|---|
| 104567 | Statistical Analysis Plan | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix/Hib Group | Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh. |
| FG001 | Infanrix+Hiberix Group | Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix/Hib Group | Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh. |
| BG001 | Infanrix+Hiberix 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 Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Month 3 |
|
Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 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 | Infanrix/Hib Group | Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
None reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C514867 | Hiberix |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL). |
| At Month 0 and Month 3 |
| Concentrations for Anti-PRP Antibodies | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL). | At Month 0 and Month 3 |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At Month 3 |
| Number of Subjects With 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses |
| Number of Subjects With Unsolicited Adverse Events (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 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 (Day 0-30) follow-up period after each vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From receipt of first dose of study vaccine (Day 0) to study end (Month 3) |
| Wuzhou |
| China |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104567 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Infanrix+Hiberix Group | Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively. |
|
|
|
| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) | A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Month 3 |
|
|
|
|
| Primary | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | The vaccine response was defined as it follows:
| The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Month 3 |
|
|
|
|
| Secondary | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL | The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Month 3 |
|
|
|
| Secondary | Concentrations for Anti-D and Anti-T Antibodies | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 0 and Month 3 |
|
|
|
| Secondary | Concentrations for Anti-PRP Antibodies | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 0 and Month 3 |
|
|
|
| Secondary | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3 |
|
|
|
| Secondary | Number of Subjects With 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. 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 at least one study vaccine administration documented and with the symptoms sheet filled in. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (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 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 analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | During the 31-day (Day 0-30) follow-up period after each vaccination |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented. | Posted | Number | Subjects | From receipt of first dose of study vaccine (Day 0) to study end (Month 3) |
|
|
|
| 4 |
| 330 |
| 278 |
| 330 |
| EG001 | Infanrix+Hiberix Group | Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively. | 7 | 328 | 290 | 330 |
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Fever (Axillary) | 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 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 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.
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| Anti-PRN |
|
| Difference in vaccine response rates against FHA: To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course. | Difference in seroresponse rate | 0.00 | 2-Sided | 95 | -2.29 | 2.30 | Non-Inferiority or Equivalence | The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of subjects with a vaccine response was ≤ 10%. |
| Difference in vaccine response rates against PRN: To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course. | Difference in seroresponse rate | 1.23 | 2-Sided | 95 | -2.17 | 5.07 | Non-Inferiority or Equivalence | The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of subjects with a vaccine response was ≤ 10%. |
| Anti-T (Month 0) |
|
| Anti-T (Month 3) |
|
| Anti-PRN |
|
| Any Redness, Dose 1 (N=323;326) |
|
| Grade 3 Redness, Dose 1 (N=323;326) |
|
| Any Swelling, Dose 1 (N=323;326) |
|
| Grade 3 Swelling, Dose 1 (N=323;326) |
|
| Any Pain, Dose 2 (N=317;313) |
|
| Grade 3 Pain, Dose 2 (N=317;313) |
|
| Any Redness, Dose 2 (N=317;313) |
|
| Grade 3 Redness, Dose 2 (N=317;313) |
|
| Any Swelling, Dose 2 (N=317;313) |
|
| Grade 3 Swelling, Dose 2 (N=317;313) |
|
| Any Pain, Dose 3 (N=316;312) |
|
| Grade 3 Pain, Dose 3 (N=316;312) |
|
| Any Redness, Dose 3 (N=316;312) |
|
| Grade 3 Redness, Dose 3 (N=316;312) |
|
| Any Swelling, Dose 3 (N=316;312) |
|
| Grade 3 Swelling, Dose 3 (N=316;312) |
|
| Any Pain, Across doses (N=323;326) |
|
| Grade 3 Pain, Across doses (N=323;326) |
|
| Any Redness, Across doses (N=323;326) |
|
| Grade 3 Redness, Across doses (N=323;326) |
|
| Any Swelling, Across doses (N=323;326) |
|
| Grade 3 Swelling, Across doses (N=323;326) |
|
| Related Drowsiness, Dose 1 (N=323;327) |
|
| Any Fever (Axillary), Dose 1 (N=323;327) |
|
| Grade 3 Fever (Axillary), Dose 1 (N=323;327) |
|
| Related Fever (Axillary), Dose 1 (N=323;327) |
|
| Any Irritability, Dose 1 (N=323;327) |
|
| Grade 3 Irritability, Dose 1 (N=323;327) |
|
| Related Irritability, Dose 1 (N=323;327) |
|
| Any Loss of appetite, Dose 1 (N=323;327) |
|
| Grade 3 Loss of appetite, Dose 1 (N=323;327) |
|
| Related Loss of appetite, Dose 1 (N=323;327) |
|
| Any Drowsiness, Dose 2 (N=317;313) |
|
| Grade 3 Drowsiness, Dose 2 (N=317;313) |
|
| Related Drowsiness, Dose 2 (N=317;313) |
|
| Any Fever (Axillary), Dose 2 (N=317;313) |
|
| Grade 3 Fever (Axillary), Dose 2 (N=317;313) |
|
| Related Fever (Axillary), Dose 2 (N=317;313) |
|
| Any Irritability, Dose 2 (N=317;313) |
|
| Grade 3 Irritability, Dose 2 (N=317;313) |
|
| Related Irritability, Dose 2 (N=317;313) |
|
| Any Loss of appetite, Dose 2 (N=317;313) |
|
| Grade 3 Loss of appetite, Dose 2 (N=317;313) |
|
| Related Loss of appetite, Dose 2 (N=317;313) |
|
| Any Drowsiness, Dose 3 (N=316;312) |
|
| Grade 3 Drowsiness, Dose 3 (N=316;312) |
|
| Related Drowsiness, Dose 3 (N=316;312) |
|
| Any Fever (Axillary), Dose 3 (N=316;312) |
|
| Grade 3 Fever (Axillary), Dose 3 (N=316;312) |
|
| Related Fever (Axillary), Dose 3 (N=316;312) |
|
| Any Irritability, Dose 3 (N=316;312) |
|
| Grade 3 Irritability, Dose 3 (N=316;312) |
|
| Related Irritability, Dose 3 (N=316;312) |
|
| Any Loss of appetite, Dose 3 (N=316;312) |
|
| Grade 3 Loss of appetite, Dose 3 (N=316;312) |
|
| Related Loss of appetite, Dose 3 (N=316;312) |
|
| Any Drowsiness, Across doses (N=323;327) |
|
| Grade 3 Drowsiness, Across doses (N=323;327) |
|
| Related Drowsiness, Across doses (N=323;327) |
|
| Any Fever (Axillary), Across doses (N=323;327) |
|
| Grade 3 Fever (Axillary), Across doses (N=323;327) |
|
| Related Fever (Axillary), Across doses (N=323;327) |
|
| Any Irritability, Across doses (N=323;327) |
|
| Grade 3 Irritability, Across doses (N=323;327) |
|
| Related Irritability, Across doses (N=323;327) |
|
| Any Loss of appetite, Across doses (N=323;327) |
|
| Grade 3 Loss of appetite, Across doses (N=323;327) |
|
| Related Loss of appetite, Across doses (N=323;327) |
|