- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01003418
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
25. september 2018 opdateret af: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks
The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Bergen, Norge, 5021
- GSK Investigational Site
-
Hønefoss, Norge, N-3515
- GSK Investigational Site
-
Lierskogen, Norge, 3420
- GSK Investigational Site
-
Oslo, Norge, 0027
- GSK Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 2 måneder (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
- Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy children, as established by medical history and clinical examination when entering 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 device.
- Born after a gestation period of >= 36 to <= 42 weeks.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- History of any neurological disorders or seizures.
- A family history of congenital or hereditary immunodeficiency.
- Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
- Administration of any vaccines within two weeks before study enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
- Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
- History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
- Major congenital defects or serious chronic illness.
- Child in care.
- Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: GSK2340272A Group 1
Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule.
Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10.
All vaccines were administered intramuscularly into the anterolateral region of the thigh.
|
Two doses; intramuscular administration
Routine infant immunisation vaccine, three doses administered intramuscularly
Routine infant immunisation vaccine, three doses administered intramuscularly
|
Eksperimentel: GSK2340272A Group 2
Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule.
Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10.
All vaccines were administered intramuscularly into the anterolateral region of the thigh.
|
Two doses; intramuscular administration
Routine infant immunisation vaccine, three doses administered intramuscularly
Routine infant immunisation vaccine, three doses administered intramuscularly
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects With Any Solicited Local or General Symptoms
Tidsramme: During the 7-days post-Dose 1 period (Days 0-6)
|
Assessed solicited local symptoms were pain, redness and swelling.
Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
|
During the 7-days post-Dose 1 period (Days 0-6)
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsramme: During the 2-weeks post-Dose 1 period (Days 0-13)
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted.
Related = AE assessed by the investigator as related to the vaccination.
|
During the 2-weeks post-Dose 1 period (Days 0-13)
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: During the 2-weeks post-Dose 1 period (Days 0-13)
|
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
|
During the 2-weeks post-Dose 1 period (Days 0-13)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects With Any Solicited Local or General Symptoms
Tidsramme: During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
|
Assessed solicited local symptoms were pain, redness and swelling.
Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
|
During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
Tidsramme: During the 28-day (Days 0-27) follow-up period after each study vaccine administration
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any AE reported in addition to those solicited during the clinical study.
Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted.
Related = AE assessed by the investigator as related to the vaccination.
Results about unsolicited AEs for this endpoint were based on individual listings.
|
During the 28-day (Days 0-27) follow-up period after each study vaccine administration
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: During the entire study period (From Month 0 up to Month 11)
|
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Results about SAEs were based on individual listings.
|
During the entire study period (From Month 0 up to Month 11)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. november 2009
Primær færdiggørelse (Faktiske)
25. november 2010
Studieafslutning (Faktiske)
25. november 2010
Datoer for studieregistrering
Først indsendt
27. oktober 2009
Først indsendt, der opfyldte QC-kriterier
27. oktober 2009
Først opslået (Skøn)
28. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 113629
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
-
Studieprotokol
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Individuelt deltagerdatasæt
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasætspecifikation
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Formular til informeret samtykke
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoteret sagsbetænkningsformular
Informations-id: 113629Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Influenza
-
Gamaleya Research Institute of Epidemiology and...AfsluttetInfluenza A | Influenza A-virusinfektion | Influenza epidemi | Influenza H5N1Den Russiske Føderation
-
NPO PetrovaxAfsluttetVaccine reaktion | Influenza | Influenza, menneske | Influenza A | Akut luftvejsinfektion | Influenza type B | Influenza | Influenza A H3N2 | Influenza A H1N1 | Influenza, menneske | Influenza epidemiDen Russiske Føderation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectAfsluttetVaccine reaktion | Influenza | Influenza, menneske | Influenza A | Influenza type B | Influenza A H3N2 | Influenza A H1N1Forenede Stater
-
Novartis VaccinesAfsluttetInfluenza | Sæsonbestemt influenza | Menneskelig influenza | Influenza på grund af uspecificeret influenzavirusBelgien
-
SeqirusNovartis VaccinesAfsluttetInfluenza | Influenza, menneske | Influenza A-virus, H5N1-undertype | Influenza, menneske | Influenza, fugleAustralien, Tyskland, Italien
-
Novartis VaccinesNovartis Vaccines and Diagnostics (formerly Chiron Vaccines)AfsluttetInfluenza sygdom; InfluenzaForenede Stater
-
Quidel CorporationAfsluttet
-
National Institute of Allergy and Infectious Diseases...AfsluttetInfluenza A | Influenza BForenede Stater
-
Ellume Pty LtdAfsluttetInfluenza A | Influenza BAustralien
-
Virginia Commonwealth UniversityAfsluttetSæsonbestemt influenza | H1N1 influenzaForenede Stater