Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
maanantai 31. heinäkuuta 2017 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tila
Valmis
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
210
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bilbao, Espanja, 48013
- GSK Investigational Site
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Burgos, Espanja, 09005
- GSK Investigational Site
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Madrid, Espanja, 28046
- GSK Investigational Site
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Móstoles/Madrid, Espanja, 28935
- GSK Investigational Site
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Sevilla, Espanja, 41013
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
3 vuotta - 17 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
1
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Kokeellinen: Ryhmä A
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Two primary intramuscular (IM) injections and a booster IM injection
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Aikaikkuna: 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).
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At Day 0
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Aikaikkuna: At Day 42
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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.
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At Day 42
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Titers for Serum HI Antibodies
Aikaikkuna: 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
|
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Titers for Serum HI Antibodies
Aikaikkuna: 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.
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At Day 42
|
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Aikaikkuna: 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.
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At Day 42
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Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Aikaikkuna: At Day 42
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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.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibody Titers
Aikaikkuna: At Day 42
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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.
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At Day 42
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Koehenkilöiden määrä, joilla on kaikki ja luokan 3 paikalliset oireet
Aikaikkuna: 7 päivän (päivät 0-6) rokotuksen jälkeisenä aikana kunkin annoksen jälkeen ja eri annoksilla
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Arvioidut paikalliset oireet olivat kipu, punoitus ja turvotus.
Mikä tahansa = oireen esiintyminen voimakkuusasteesta riippumatta.
Asteen 3 kipu = kipu, joka esti normaalia toimintaa.
Asteen 3 punoitus/turvotus = punoitus/turvotus, joka leviää yli 50 millimetriä (mm) pistoskohdasta.
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7 päivän (päivät 0-6) rokotuksen jälkeisenä aikana kunkin annoksen jälkeen ja eri annoksilla
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Aikaikkuna: At Days 0, 21, 42 and at Month 12
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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.
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At Days 0, 21, 42 and at Month 12
|
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Titers for Serum HI Antibodies
Aikaikkuna: 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
Aikaikkuna: 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.
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At Days 21, 42 and at Month 12
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Number of Seroprotected Subjects in Terms of HI Antibodies
Aikaikkuna: 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
|
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Seroconversion Factor (SCF) for HI Antibody Titers
Aikaikkuna: 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.
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At Days 21, 42 and at Month 12
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Aikaikkuna: At Days 0, 21 and 42
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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.
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At Days 0, 21 and 42
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Titers for Serum Neutralizing Antibodies
Aikaikkuna: At Days 0, 21 and 42
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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).
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At Days 0, 21 and 42
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Aikaikkuna: At Month 12
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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.
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At Month 12
|
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Titers for Serum Neutralizing Antibodies
Aikaikkuna: 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.
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At Month 12
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Aikaikkuna: At Days 21 and 42
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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.
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At Days 21 and 42
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Aikaikkuna: At Month 12
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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.
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At Month 12
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Aikaikkuna: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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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.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Aikaikkuna: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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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.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any Medically-attended Events (MAEs)
Aikaikkuna: During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Aikaikkuna: During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Normal or Abnormal Biochemical Levels
Aikaikkuna: At Days 0, 21 and 42
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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.
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At Days 0, 21 and 42
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Aikaikkuna: During the 21-day (Days 0-20) follow-up period after the first vaccination
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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.
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During the 21-day (Days 0-20) follow-up period after the first vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Aikaikkuna: 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
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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.
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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
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Number of Subjects With Serious Adverse Events (SAEs)
Aikaikkuna: During the entire study period (from Day 0 up to Month 12)
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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.
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During the entire study period (from Day 0 up to Month 12)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
- Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Opiskelun aloitus
Torstai 10. syyskuuta 2009
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Lauantai 27. marraskuuta 2010
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Lauantai 27. marraskuuta 2010
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Torstai 20. elokuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 20. elokuuta 2009
Ensimmäinen Lähetetty (Arvio)
Ensimmäinen Lähetetty
Maanantai 24. elokuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Maanantai 19. helmikuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 31. heinäkuuta 2017
Viimeksi vahvistettu
Viimeksi vahvistettu
Lauantai 1. lokakuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 113528
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Tutkimustiedot/asiakirjat
-
Tilastollinen analyysisuunnitelma
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Ilmoitettu suostumuslomake
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Kliinisen tutkimuksen raportti
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
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Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tutkimuspöytäkirja
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tietojoukon määritys
Tiedon tunniste: 113528Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .