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The study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
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The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2340272A Group 1 | Experimental | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrixâ„¢-IPV/Hib) and Prevenarâ„¢ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
|
| GSK2340272A Group 2 | Experimental | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrixâ„¢-IPV/Hib) and Prevenarâ„¢ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine | Biological | Two doses; intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | During the 7-days post-Dose 1 period (Days 0-6) |
| Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. | During the 2-weeks post-Dose 1 period (Days 0-13) |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | During the 2-weeks post-Dose 1 period (Days 0-13) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2) |
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Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bergen | 5021 | Norway | |||
| GSK Investigational Site |
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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 |
|---|---|---|---|
| 113629 | 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.
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Subjects who were enrolled completed the study but the lack of data due to the small enrollment number prevented any statistical analyses to be performed. No statistical analyses were performed as per planned in the protocol. All study results summarized below are based solely on individual data listings generated.
Only 8 subjects were enrolled in the study as the study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2340272A Group 1 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Infanrixâ„¢-IPV/Hib | Biological | Routine infant immunisation vaccine, three doses administered intramuscularly |
|
| Prevenar | Biological | Routine infant immunisation vaccine, three doses administered intramuscularly |
|
| Number of Subjects With Any, Grade 3 and Related Unsolicited 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 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 will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. Results about unsolicited AEs for this endpoint were based on individual listings. |
| During the 28-day (Days 0-27) follow-up period after each study vaccine administration |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings. | During the entire study period (From Month 0 up to Month 11) |
| Hønefoss |
| N-3515 |
| Norway |
| GSK Investigational Site | Lierskogen | 3420 | Norway |
| GSK Investigational Site | Oslo | 0027 | Norway |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113629 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113629 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113629 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113629 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113629 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | GSK2340272A Group 2 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2340272A Group 1 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
| BG001 | GSK2340272A Group 2 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | Posted | Count of Participants | Participants | During the 7-days post-Dose 1 period (Days 0-6) |
|
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| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. | Posted | Count of Participants | Participants | During the 2-weeks post-Dose 1 period (Days 0-13) |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. | Posted | Count of Participants | Participants | During the 2-weeks post-Dose 1 period (Days 0-13) |
|
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| Secondary | Number of Subjects With Any Solicited Local or General Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. | Posted | Count of Participants | Participants | During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited 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 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 will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. Results about unsolicited AEs for this endpoint were based on individual listings. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 28-day (Days 0-27) follow-up period after each study vaccine administration |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (From Month 0 up to Month 11) |
|
Solicited symptoms: within the 7-day (Days 0-6) follow-up period after each study vaccination. Unsolicited AEs: within the 28-day (Days 0-27) follow-up period after each study vaccination. SAEs: throughout the entire study period (from Month 0 up to Month 11).
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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 | GSK2340272A Group 1 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG001 | GSK2340272A Group 2 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. | 0 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tracheal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Redness | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Drowsiness | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Loss of appetite | General disorders | MedDRA 13.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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| Male |
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| White-Caucasian/European heritage |
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| Swelling |
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| Drowsiness |
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| Fever |
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| Irritability |
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| Loss of appetite |
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| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG001 | GSK2340272A Group 2 | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix-IPV/Hib) and Prevenar vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
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