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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000758-41 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-QIV | Experimental | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). |
|
| Control | Active Comparator | In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With RT-PCR Confirmed Influenza of Any Severity. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participation in a previous FLU-D-QIV-004 study (115345) cohort.
Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
Any contraindication to intramuscular injection.
Acute disease and/or fever at the time of enrolment.
Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Additional criteria for children ≥ 12 months of age:
Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
Any history of hepatitis A or varicella diseases.
Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dhaka | 1000 | Bangladesh | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35083365 | Derived | Danier J, Callegaro A, Soni J, Carmona A, Kosalaraska P, Rivera L, Friel D, Pu W, Vantomme V, Dbaibo G, Innis BL, Schuind A, Zaman K, Wilson J. Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction-Confirmed Influenza Illness in Children 6-35 Months of Age: Statistical Evaluation of a Correlate of Protection. Open Forum Infect Dis. 2021 Sep 25;9(2):ofab477. doi: 10.1093/ofid/ofab477. eCollection 2022 Feb. | |
| 31725115 |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
Not provided
IPD for this study will be made available via the Clinical Study Data Request site.
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.
Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | D-QIV | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). |
| FG001 | Control | In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Havrix Junior | Biological | Intramuscular injection administered to subjects aged 12 months or older |
|
| Prevenar 13 | Biological | Intramuscular injection administered to subjects less than 12 months of age |
|
| Varivax/ProVarivax | Biological | Intramuscular injection administered to subjects more than 12 months of age |
|
| Varilrix | Biological | Subcutaneous injection administered to subjects more than 12 months of age |
|
| Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) |
| Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | During the surveillance period (approximately 6 to 8 months) |
| Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | At Days 0 and 28/56 |
| Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. | At Day 0 and Day 28/56 |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | At Day 28/56 (POST) |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. | At Day 28/56 (POST) |
| Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | At Day 0 and Day 28/56 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
| Duration of Solicited Local Symptoms | Duration was defined as number of days with any grade of local symptoms. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
| Duration of Solicited General Symptoms | Duration was defined as number of days with any grade of general symptoms. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | During the 28-day (Days 0-27) post-vaccination period |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination. | During the entire study period (approximately 6- 8 months per subject) |
| Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination. | During the entire study period (approximately 6- 8 months per subject) |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination. | During the entire study period (approximately 6- 8 months per subject) |
| Antwerp |
| 2018 |
| Belgium |
| GSK Investigational Site | Antwerp | 2020 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Mechelen | 2800 | Belgium |
| GSK Investigational Site | Namur | 5000 | Belgium |
| GSK Investigational Site | Roeselaere | 8800 | Belgium |
| GSK Investigational Site | Turnhout | 2300 | Belgium |
| GSK Investigational Site | Děčín | 405 01 | Czechia |
| GSK Investigational Site | Humpolec | 396 01 | Czechia |
| GSK Investigational Site | Jindřichův Hradec | 37701 | Czechia |
| GSK Investigational Site | Liberec | 46015 | Czechia |
| GSK Investigational Site | Lipník nad Bečvou | 75131 | Czechia |
| GSK Investigational Site | Náchod | 547 01 | Czechia |
| GSK Investigational Site | Odolena Voda | 25070 | Czechia |
| GSK Investigational Site | Ostrava - Poruba | 70800 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Prague | 1600 | Czechia |
| GSK Investigational Site | Tábor | 390 02 | Czechia |
| GSK Investigational Site | Santo Domingo | Dominican Republic |
| GSK Investigational Site | Santo Domingo, Distrito Nacional | Dominican Republic |
| GSK Investigational Site | San Pedro Sula | Honduras |
| GSK Investigational Site | Tegucigalpa | Honduras |
| GSK Investigational Site | Faridabad | 121004 | India |
| GSK Investigational Site | Pune | 411 011 | India |
| GSK Investigational Site | Pune | India |
| GSK Investigational Site | Beirut | 1107-2020 | Lebanon |
| GSK Investigational Site | City of Muntinlupa | 1781 | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Manila | Philippines |
| GSK Investigational Site | Metro Manila | 1000 | Philippines |
| GSK Investigational Site | Quezon City | 1113 | Philippines |
| GSK Investigational Site | Sampaloc, Manila | 1008 | Philippines |
| GSK Investigational Site | Bydgoszcz | 85-079 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-168 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-316 | Poland |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Gdansk | 84-462 | Poland |
| GSK Investigational Site | Grudziądz | 86-330 | Poland |
| GSK Investigational Site | Katowice | 40-018 | Poland |
| GSK Investigational Site | Katowice | 40-129 | Poland |
| GSK Investigational Site | Krakow | 31-223 | Poland |
| GSK Investigational Site | Lodz | 90-242 | Poland |
| GSK Investigational Site | Lublin | 20-044 | Poland |
| GSK Investigational Site | Oborniki | 55-120 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| GSK Investigational Site | Poznan | 62-064 | Poland |
| GSK Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Torun | Poland |
| GSK Investigational Site | Warsaw | 00-315 | Poland |
| GSK Investigational Site | Wola | 43-225 | Poland |
| GSK Investigational Site | Wroclaw | 52-312 | Poland |
| GSK Investigational Site | Łęczna | 21-010 | Poland |
| GSK Investigational Site | Antequera/Málaga | 29200 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08042 | Spain |
| GSK Investigational Site | Blanes (Girona) | 17300 | Spain |
| GSK Investigational Site | Boadilla del Monte | 28660 | Spain |
| GSK Investigational Site | Castellon | 12004 | Spain |
| GSK Investigational Site | Castellon | 12530 | Spain |
| GSK Investigational Site | Centelles (Barcelona) | 08540 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28035 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28700 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28224 | Spain |
| GSK Investigational Site | Quart de Poblet, Valencia | 46930 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Seville | 41927 | Spain |
| GSK Investigational Site | Torrelodones (Madrid) | 28250 | Spain |
| GSK Investigational Site | Valencia | 46011 | Spain |
| GSK Investigational Site | Valencia | 46024 | Spain |
| GSK Investigational Site | Valencia | 46200 | Spain |
| GSK Investigational Site | Valencia | 46702 | Spain |
| GSK Investigational Site | Vic/ Barcelona | 08500 | Spain |
| GSK Investigational Site | Xativa/Valencia | 46800 | Spain |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Bursa | Turkey (Türkiye) |
| GSK Investigational Site | Eskişehir | Turkey (Türkiye) |
| GSK Investigational Site | Istanbul | 34890 | Turkey (Türkiye) |
| GSK Investigational Site | St Austell | Cornwall | PL26 7RL | United Kingdom |
| GSK Investigational Site | Southampton | Hampshire | SO16 6YD | United Kingdom |
| GSK Investigational Site | Axbridge | Somerset | BS26 2BJ | United Kingdom |
| GSK Investigational Site | Bath | Somerset | BA1 3NG | United Kingdom |
| GSK Investigational Site | Yeovil | Somerset | BA21 4AT | United Kingdom |
| GSK Investigational Site | Atherstone | Warwickshire | CV9 1EU | United Kingdom |
| GSK Investigational Site | Coventry | Warwickshire | CV6 4DD | United Kingdom |
| GSK Investigational Site | Belfast | BT7 2EB | United Kingdom |
| GSK Investigational Site | Bolton, Nr Manchester | BL3 6TL | United Kingdom |
| GSK Investigational Site | Bristol | BS2 8AE | United Kingdom |
| GSK Investigational Site | Co Antrim | BT41 3AE | United Kingdom |
| GSK Investigational Site | Crumpsall, Manchester | M8 9JT | United Kingdom |
| GSK Investigational Site | Exeter | EX2 5DW | United Kingdom |
| GSK Investigational Site | Gloucester | GL1 3NN | United Kingdom |
| GSK Investigational Site | London | SW17 0QT | United Kingdom |
| GSK Investigational Site | Manchester | M13 9WL | United Kingdom |
| GSK Investigational Site | Nottingham | NG7 2QW | United Kingdom |
| GSK Investigational Site | Oxford | OX3 7LJ | United Kingdom |
| GSK Investigational Site | Taunton, Somerset | TA1 5DA | United Kingdom |
| GSK Investigational Site | Westminster Bridge Road | SE1 7EH | United Kingdom |
| Derived |
| Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL; Flu4VEC Study Group. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial. Pediatr Infect Dis J. 2020 Jan;39(1):e1-e10. doi: 10.1097/INF.0000000000002504. |
| 31306399 | Derived | Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387. |
| 30325891 | Derived | Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217. |
| COMPLETED |
|
| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | D-QIV | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). |
| BG001 | Control | In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). |
| 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 | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
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| Primary | Number of Subjects With RT-PCR Confirmed Influenza of Any Severity. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
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| Secondary | Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) |
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| Secondary | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
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| Secondary | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
|
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| Secondary | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
|
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| Secondary | Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) |
|
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| Secondary | Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain. | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | Posted | Count of Participants | Participants | During the surveillance period (approximately 6 to 8 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 and 28/56 |
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| Secondary | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. | The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 28/56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 28/56 (POST) |
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| Secondary | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. | The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 28/56 (POST) |
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| Secondary | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects | The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 0 and Day 28/56 |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed). | Posted | Count of Participants | Participants | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
|
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed). | Posted | Count of Participants | Participants | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
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| Secondary | Duration of Solicited Local Symptoms | Duration was defined as number of days with any grade of local symptoms. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed). | Posted | Median | Full Range | Days | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
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| Secondary | Duration of Solicited General Symptoms | Duration was defined as number of days with any grade of general symptoms. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed). | Posted | Median | Full Range | Days | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 28-day (Days 0-27) post-vaccination period |
|
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (approximately 6- 8 months per subject) |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (approximately 6- 8 months per subject) |
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| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (approximately 6- 8 months per subject) |
|
|
Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-QIV | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). | 217 | 6,006 | 3,427 | 6,006 | ||
| EG001 | Control | In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). | 201 | 6,012 | 3,501 | 6,012 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypochromic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypoplastic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Phimosis | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intussusception | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Drowning | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Anaphylactic shock | Immune system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Abscess limb | Infections and infestations | Systematic Assessment |
| ||
| Acarodermatitis | Infections and infestations | Systematic Assessment |
| ||
| Amoebiasis | Infections and infestations | Systematic Assessment |
| ||
| Amoebic dysentery | Infections and infestations | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Ascariasis | Infections and infestations | Systematic Assessment |
| ||
| Atypical pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Bacterial pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Chest wall abscess | Infections and infestations | Systematic Assessment |
| ||
| Chikungunya virus infection | Infections and infestations | Systematic Assessment |
| ||
| Cholera | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Systematic Assessment |
| ||
| Dengue fever | Infections and infestations | Systematic Assessment |
| ||
| Diarrhoea infectious | Infections and infestations | Systematic Assessment |
| ||
| Dysentery | Infections and infestations | Systematic Assessment |
| ||
| Enterovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Escherichia pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Exanthema subitum | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis norovirus | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis rotavirus | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis shigella | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | Systematic Assessment |
| ||
| Hepatitis a | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Mastoiditis | Infections and infestations | Systematic Assessment |
| ||
| Meningitis viral | Infections and infestations | Systematic Assessment |
| ||
| Mycoplasma infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Systematic Assessment |
| ||
| Parasitic gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Periorbital cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Peritonsillar abscess | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngotonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia bacterial | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia measles | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia mycoplasmal | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia respiratory syncytial viral | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia viral | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Rotavirus infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Tuberculosis | Infections and infestations | Systematic Assessment |
| ||
| Typhoid fever | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Varicella | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Viral rash | Infections and infestations | Systematic Assessment |
| ||
| Viral rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Viral sepsis | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Accidental exposure to product | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Accidental poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Animal bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Burns second degree | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chemical poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foreign body | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foreign body aspiration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Near drowning | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pelvic fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood electrolytes abnormal | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Polydipsia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Facial paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Febrile convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Seizure anoxic | Nervous system disorders | Systematic Assessment |
| ||
| Status epilepticus | Nervous system disorders | Systematic Assessment |
| ||
| Cystitis haemorrhagic | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrotic syndrome | Renal and urinary disorders | Systematic Assessment |
| ||
| Balanoposthitis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Testicular pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
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