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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

2017. július 31. frissítette: GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

210

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Spanyolország
      • Bilbao, Spanyolország, 48013
        • GSK Investigational Site
      • Burgos, Spanyolország, 09005
        • GSK Investigational Site
      • Madrid, Spanyolország, 28046
        • GSK Investigational Site
      • Móstoles/Madrid, Spanyolország, 28935
        • GSK Investigational Site
      • Sevilla, Spanyolország, 41013
        • GSK Investigational Site

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

3 év (Gyermek)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • Child in Care.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Megelőzés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: A csoport
Biológiai: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Időkeret: At Day 0
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
At Day 0
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Időkeret: At Day 42
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Day 42
Titers for Serum HI Antibodies
Időkeret: At Day 0
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 0
Titers for Serum HI Antibodies
Időkeret: At Day 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Időkeret: At Day 42
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Időkeret: At Day 42
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Seroconversion Factor (SCF) for HI Antibody Titers
Időkeret: At Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Day 42

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Bármilyen és 3. fokozatú kért helyi tünetet mutató alanyok száma
Időkeret: Az egyes adagokat követő 7 napos (0-6. nap) vakcinázást követő időszakban
A kért helyi tünetek a fájdalom, a bőrpír és a duzzanat voltak. Bármelyik = a tünet előfordulása intenzitási fokozattól függetlenül. 3. fokozatú fájdalom = fájdalom, amely megakadályozta a normális tevékenységet. 3. fokozatú bőrpír/duzzanat = bőrpír/duzzanat, amely az injekció beadásának helyén 50 milliméteren (mm) túl terjed.
Az egyes adagokat követő 7 napos (0-6. nap) vakcinázást követő időszakban
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Időkeret: At Days 0, 21, 42 and at Month 12
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Titers for Serum HI Antibodies
Időkeret: At Days 0, 21, 42 and at Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Időkeret: At Days 21, 42 and at Month 12
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Seroprotected Subjects in Terms of HI Antibodies
Időkeret: At Days 0, 21, 42 and at Month 12
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Seroconversion Factor (SCF) for HI Antibody Titers
Időkeret: At Days 21, 42 and at Month 12
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Időkeret: At Days 0, 21 and 42
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies
Időkeret: At Days 0, 21 and 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
At Days 0, 21 and 42
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Időkeret: At Month 12
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Month 12
Titers for Serum Neutralizing Antibodies
Időkeret: At Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Időkeret: At Days 21 and 42
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Days 21 and 42
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Időkeret: At Month 12
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Időkeret: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Időkeret: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
Időkeret: During the entire study period (from Day 0 up to Month 12)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Időkeret: During the entire study period (from Day 0 up to Month 12)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Normal or Abnormal Biochemical Levels
Időkeret: At Days 0, 21 and 42
Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
At Days 0, 21 and 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Időkeret: During the 21-day (Days 0-20) follow-up period after the first vaccination
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. Related = AE assessed by the investigator as related to the vaccination.
During the 21-day (Days 0-20) follow-up period after the first vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Időkeret: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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. Related = AE assessed by the investigator as related to the vaccination.
During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Időkeret: During the entire study period (from Day 0 up to Month 12)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire study period (from Day 0 up to Month 12)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

GlaxoSmithKline

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2009. szeptember 10.

Elsődleges befejezés (Tényleges)

2010. november 27.

A tanulmány befejezése (Tényleges)

2010. november 27.

Tanulmányi regisztráció dátumai

Először benyújtva

2009. augusztus 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2009. augusztus 20.

Első közzététel (Becslés)

2009. augusztus 24.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. február 19.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. július 31.

Utolsó ellenőrzés

2016. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 113528

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Tanulmányi adatok/dokumentumok

  1. Statisztikai elemzési terv
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  2. Jegyzetekkel ellátott esetjelentési űrlap
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  3. Tájékozott hozzájárulási űrlap
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinikai vizsgálati jelentés
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  5. Egyéni résztvevő adatkészlet
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  6. Tanulmányi Protokoll
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register
  7. Adatkészlet specifikáció
    Információs azonosító: 113528
    Információs megjegyzések: For additional information about this study please refer to the GSK Clinical Study Register

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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