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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000162-38 | EudraCT Number |
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The purpose of the study is to evaluate the safety and reactogenicity of Synflorixâ„¢ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexaâ„¢ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix Group | Experimental | Subjects receiving Synflorixâ„¢(GSK 1024850A) co-administered along with Infanrix hexaâ„¢. |
|
| Control Group | Active Comparator | Subjects receiving Infanrix hexaâ„¢ vaccine alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorixâ„¢( GSK1024850A) | Biological | Intramuscular, 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) | The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented. | Within the 31-day (Days 0-30) after each dose and across doses |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | During the 4-day (Days 0-3) post-vaccination period following each dose |
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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 | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23432812 | Background | Huu TN, Toan NT, Tuan HM, Viet HL, Le Thanh Binh P, Yu TW, Shafi F, Habib A, Borys D. Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 2013 Feb 21;13:95. doi: 10.1186/1471-2334-13-95. | |
| Background | Tran NH et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. Abstract presented at the ICID, Bangkok, Thailand, June 13-16, 2012. |
| 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 |
|---|---|---|---|
| 113151 | Clinical Study Report | 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.
300 subjects were enrolled in this study. 2 subjects among the 101 subjects in the Infanrix Hexa Group were not vaccinated due to consent withdrawal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synflorix+Infanrix Hexa Group | Healthy male or female subjects who received the Synflorixâ„¢ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexaâ„¢ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
| FG001 | Infanrix Hexa Group | Healthy male or female subjects who received the Infanrix hexaâ„¢ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Synflorix+Infanrix Hexa Group | Healthy male or female subjects who received the Synflorixâ„¢ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexaâ„¢ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 With Grade 3 Symptoms (Solicited and Unsolicited) | The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) after each dose and across doses |
|
Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 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 | Synflorix+Infanrix Hexa Group | Healthy male or female subjects who received the Synflorixâ„¢ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexaâ„¢ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Infanrix hexaâ„¢ |
| Biological |
Intramuscular, 3 doses |
|
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | During the 4-day (Days 0-3) post-vaccination period following each dose |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE is 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | During the 31-day (Days 0-30) follow-up period after each dose |
| 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. | After the first vaccination up to study end (From Month 0 to Month 3) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113151 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113151 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113151 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113151 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113151 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Protocol Violation |
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| Lost to Follow-up |
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| Infanrix Hexa Group |
Healthy male or female subjects who received the Infanrix hexaâ„¢ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Infanrix Hexa Group | Healthy male or female subjects who received the Infanrix hexaâ„¢ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. |
|
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each dose |
|
|
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE is 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after each dose |
|
|
|
| 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 vaccine administration documented. | Posted | Count of Participants | Participants | After the first vaccination up to study end (From Month 0 to Month 3) |
|
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| 9 |
| 199 |
| 195 |
| 199 |
| EG001 | Infanrix Hexa Group | Healthy male or female subjects who received the Infanrix hexaâ„¢ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age. | 6 | 99 | 91 | 99 |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Superinfection fungal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Redness | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Drowsiness | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fever (Axillary) | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Loss of appetite | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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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.
| Grade 3 Pain Dose 1 |
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| Any Redness Dose 1 |
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| Grade 3 Drowsiness Dose 1 |
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| Related Drowsiness Dose 1 |
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| Any Loss of appetite Dose 1 |
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