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The purpose of this study was to investigate the following questions through post-marketing surveillance:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix Group | Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' Infanrix™ | Biological | Primary and booster vaccination according to vaccination schedule. Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events | A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Since the beginning of the study and during the entire study period (up to 6 years) |
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting. | During the 4-week follow-up period after each dose |
| Number of Subjects Reporting Unsolicited Adverse Events | An adverse event 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. | Within the 31-day (Day 0-30) following vaccination. |
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Inclusion Criteria:
All children receiving Infanrix™ were eligible for this survey.
Exclusion Criteria:
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All children receiving Infanrix™ were eligible for this survey.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Daegu | 700-712 | South Korea |
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| 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 |
|---|---|---|---|
| 208355/128 | Study Protocol | 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix Group | Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix Group | Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). |
| 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 Reporting Serious Adverse Events | A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Number | Subjects | Since the beginning of the study and during the entire study period (up to 6 years) |
|
SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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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 Group | Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Croup infectious | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration PRI D1 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 208355/128 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208355/128 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208355/128 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208355/128 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 208355/128 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting. | Analysis was performed on the subjects who received the considered dose. | Posted | Number | Subjects | During the 4-week follow-up period after each dose |
|
|
|
| Primary | Number of Subjects Reporting Unsolicited Adverse Events | An adverse event 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. | Posted | Number | Subjects | Within the 31-day (Day 0-30) following vaccination. |
|
|
|
| 0 |
| 1,258 |
| 3 |
| 1,258 |
| 90 |
| 877 |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
|
| Induration PRI D2 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Induration PRI D3 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Redness PRI D1 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Redness PRI D2 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Redness PRI D3 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Swelling PRI D2 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Drowsiness PRI D1 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Irritability PRI D1 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Irritability PRI D2 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Irritability PRI D3 | General disorders | Systematic Assessment | The number of subjects at risk is the total number of subjects that received the respective dose. |
|
| Swelling PRI D3 | General disorders | Systematic Assessment |
|
| Induration BST 15-18M | General disorders | Systematic Assessment |
|
| Itching BST 15-18M | General disorders | Systematic Assessment |
|
| Pain BST 15-18M | General disorders | Systematic Assessment |
|
| Redness BST 15-18M | General disorders | Systematic Assessment |
|
| Swelling BST 15-18M | General disorders | Systematic Assessment |
|
| Induration BST 4-6Y | General disorders | Systematic Assessment |
|
| Itching BST 4-6Y | General disorders | Systematic Assessment |
|
| Pain BST 4-6Y | General disorders | Systematic Assessment |
|
| Redness BST 4-6Y | General disorders | Systematic Assessment |
|
| Swelling BST 4-6Y | General disorders | Systematic Assessment |
|
| Anorexia PRI D1 | General disorders | Systematic Assessment |
|
| Fever PRI D1 | General disorders | Systematic Assessment |
|
| Anorexia BST 15-18M | General disorders | Systematic Assessment |
|
| Drowsiness BST 15-18M | General disorders | Systematic Assessment |
|
| Fever BST 15-18M | General disorders | Systematic Assessment |
|
| Irritability BST 15-18M | General disorders | Systematic Assessment |
|
| Fever BST 4-6Y | General disorders | 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.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| Title | Measurements |
|---|---|
|
| Induration after Booster at 15-18 Months (n=88) |
|
| Induration after Booster at 4-6 Years (n=22) |
|
| Itching after Dose 1 (n=798) |
|
| Itching after Dose 2 (n=843) |
|
| Itching after Dose 3 (n=877) |
|
| Itching after Booster at 15-18 Months (n=88) |
|
| Itching after Booster at 4-6 Years (n=22) |
|
| Pain after Dose 1 (n=798) |
|
| Pain after Dose 2 (n=843) |
|
| Pain after Dose 3 (n=877) |
|
| Pain after Booster at 15-18 Months (n=88) |
|
| Pain after Booster at 4-6 Years (n=22) |
|
| Redness after Dose 1 (n=798) |
|
| Redness after Dose 2 (n=843) |
|
| Redness after Dose 3 (n=877) |
|
| Redness after Booster at 15-18 Months (n=88) |
|
| Redness after Booster at 4-6 Years (n=22) |
|
| Swelling after Dose 1 (n=798) |
|
| Swelling after Dose 2 (n=843) |
|
| Swelling after Dose 3 (n=877) |
|
| Swelling after Booster at 15-18 Months (n=88) |
|
| Swelling after Booster at 4-6 Years (n=22) |
|
| Anorexia after Dose 1 (n=798) |
|
| Anorexia after Dose 2 (n=843) |
|
| Anorexia after Dose 3 (n=877) |
|
| Anorexia after Booster at 15-18 Months (n=88) |
|
| Anorexia after Booster at 4-6 Years (n=22) |
|
| Convulsions after Dose 1 (n=798) |
|
| Convulsions after Dose 2 (n=843) |
|
| Convulsions after Dose 3 (n=877) |
|
| Convulsions after Booster at 15-18 Months (n=88) |
|
| Convulsions after Booster at 4-6 Years (n=22) |
|
| Cough after Dose 1 (n=798) |
|
| Cough after Dose 2 (n=843) |
|
| Cough after Dose 3 (n=877) |
|
| Cough after Booster at 15-18 Months (n=88) |
|
| Cough after Booster at 4-6 Years (n=22) |
|
| Diarrhea after Dose 1 (n=798) |
|
| Diarrhea after Dose 2 (n=843) |
|
| Diarrhea after Dose 3 (n=877) |
|
| Diarrhea after Booster at 15-18 Months (n=88) |
|
| Diarrhea after Booster at 4-6 Years (n=22) |
|
| Drowsiness after Dose 1 (n=798) |
|
| Drowsiness after Dose 2 (n=843) |
|
| Drowsiness after Dose 3 (n=877) |
|
| Drowsiness after Booster at 15-18 Months (n=88) |
|
| Drowsiness after Booster at 4-6 Years (n=22) |
|
| Eruption after Dose 1 (n=798) |
|
| Eruption after Dose 2 (n=843) |
|
| Eruption after Dose 3 (n=877) |
|
| Eruption after Booster at 15-18 Months (n=88) |
|
| Eruption after Booster at 4-6 Years (n=22) |
|
| Fever after Dose 1 (n=798) |
|
| Fever after Dose 2 (n=843) |
|
| Fever after Dose 3 (n=877) |
|
| Fever after Booster at 15-18 Months (n=88) |
|
| Fever after Booster at 4-6 Years (n=22) |
|
| Irritability after Dose 1 (n=798) |
|
| Irritability after Dose 2 (n=843) |
|
| Irritability after Dose 3 (n=877) |
|
| Irritability after Booster at 15-18 Months (n=88) |
|
| Irritability after Booster at 4-6 Years (n=22) |
|
| Vomiting after Dose 1 (n=798) |
|
| Vomiting after Dose 2 (n=843) |
|
| Vomiting after Dose 3 (n=877) |
|
| Vomiting after Booster at 15-18 Months (n=88) |
|
| Vomiting after Booster at 4-6 Years (n=22) |
|