Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
9 maj 2018 uppdaterad av: GlaxoSmithKline
Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
720
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Saku, Estland, 75501
- GSK Investigational Site
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Tallinn, Estland, 13419
- GSK Investigational Site
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Tartu, Estland, 50417
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria:
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Experimentell: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Tidsram: Days 0 and 21
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Titers were expressed as Geometric Mean Titers (GMTs).
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Tidsram: Days 0 and 21
|
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
|
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Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Tidsram: Day 21
|
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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HI Antibody Seroconversion Factors
Tidsram: Day 21
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Tidsram: Days 0 and 21
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A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
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Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Tidsram: During a 7-day period after vaccination
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Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Any: any symptom regardless of intensity grade.
Grade 3 pain: considerable pain at rest, which prevented normal everyday activities.
Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
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During a 7-day period after vaccination
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Duration of Solicited Local Symptoms
Tidsram: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Tidsram: During a 7-day period after vaccination
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Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C).
Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C.
Related: symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day period after vaccination
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Duration of Solicited General Symptoms
Tidsram: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsram: During a 21-day period after vaccination
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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.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Tidsram: During a 21-day period after vaccination
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Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Tidsram: During the entire study period (up to Day 21)
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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During the entire study period (up to Day 21)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
3 mars 2008
Primärt slutförande (Faktisk)
11 april 2008
Avslutad studie (Faktisk)
11 april 2008
Studieregistreringsdatum
Först inskickad
29 februari 2008
Först inskickad som uppfyllde QC-kriterierna
10 mars 2008
Första postat (Uppskatta)
11 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 maj 2018
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 111454
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Statistisk analysplan
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Informerat samtycke
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 111454Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .