- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01678677
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers
12. maj 2017 opdateret af: GlaxoSmithKline
An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Biologisk: NTHI vaccine GSK2838500A (formulation 1)
- Biologisk: NTHI vaccine GSK2838501A (formulation 2)
- Biologisk: NTHI vaccine GSK2838502A (formulation 3)
- Biologisk: NTHI vaccine GSK2838503A (formulation 4)
- Biologisk: NTHI vaccine GSK2838504A (formulation 5)
- Biologisk: NTHI vaccine GSK2838505A (formulation 6)
- Biologisk: NTHI vaccine GSK2838508A (formulation 7)
- Biologisk: NTHI vaccine GSK2838509A (formulation 8)
- Medicin: Placebo comparator
Detaljeret beskrivelse
This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012, leading to a change in an inclusion criterion.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
272
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Antwerpen, Belgien, 2060
- GSK Investigational Site
-
Gent, Belgien, 9000
- GSK Investigational Site
-
Wilrijk, Belgien, 2610
- 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
50 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 50 and 70 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
- Current or former smokers.
- A smoking history of at least 10 pack-years.
- Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- 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.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
- Previous vaccination with any vaccine containing NTHi-antigens.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of or current autoimmune disease.
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted normal value.
- Diagnosed with a respiratory disorder. Please note that subjects with mild pulmonary obstruction can be enrolled.
- Laboratory evidence of clinically significant haematological abnormalities at Screening.
- Acute disease and/or fever at the time of enrolment.
- Current alcoholism and/or drug abuse.
- Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
- History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- Has contraindication for spirometry testing.
- Malignancies within previous 5 years and lymphoproliferative disorders.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any other condition that the investigator judges may interfere with study findings.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group A
Subjects in this group will receive formulation 1 of NTHi vaccine.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group B
Subjects in this group will receive formulation 2 of NTHi vaccine.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group C
Subjects in this group will receive formulation 3 of NTHi vaccine.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group D
Subjects in this group will receive formulation 4 of NTHi vaccine.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group E
Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group F
Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group G
Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Eksperimentel: Group H
Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Placebo komparator: Group Placebo 1
Subjects in this group will receive placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Placebo komparator: Group Placebo 2
Subjects in this group will receive placebo.
|
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.
Tidsramme: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
|
During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
|
Occurrence of any unsolicited AE, in all subjects, in all groups.
Tidsramme: During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
|
During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
|
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Tidsramme: Prior to each vaccination.
|
Prior to each vaccination.
|
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Tidsramme: 7 days after each vaccination.
|
7 days after each vaccination.
|
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Tidsramme: At study conclusion (Day 420).
|
At study conclusion (Day 420).
|
Occurrence of any serious adverse event (SAE), in all subjects, in all groups.
Tidsramme: From first vaccination (Day 0) to study conclusion (Day 420).
|
From first vaccination (Day 0) to study conclusion (Day 420).
|
Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.
Tidsramme: From first vaccination (Day 0) to study conclusion (Day 420).
|
From first vaccination (Day 0) to study conclusion (Day 420).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.
Tidsramme: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
|
Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
|
Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.
Tidsramme: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
|
Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
31. august 2012
Primær færdiggørelse (Faktiske)
30. januar 2014
Studieafslutning (Faktiske)
30. januar 2014
Datoer for studieregistrering
Først indsendt
23. august 2012
Først indsendt, der opfyldte QC-kriterier
30. august 2012
Først opslået (Skøn)
5. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116647
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 Åndedrætsforstyrrelser
-
Hospices Civils de LyonAfsluttetAkut Respiratory Distress Syndrome (ARDS)Frankrig
-
Aqualung Therapeutics Corp.Ikke rekrutterer endnuAkut Respiratory Distress Syndrome (ARDS)
-
Unity Health TorontoRekrutteringAkut Respiratory Distress Syndrome (ARDS)Canada, Spanien, Italien, Brasilien
-
Hospices Civils de LyonAfsluttetAkut Respiratory Distress Syndrome (ARDS)Frankrig
-
European Society of Intensive Care MedicineAfsluttetModerat Akut Respiratory Distress SyndromeBelgien
-
Policlinico HospitalAfsluttetAkut Respiratory Distress Syndrome (ARDS)Italien
-
Gamaleya Research Institute of Epidemiology and...Ikke rekrutterer endnuAkut Respiratory Distress Syndrome (ARDS)
-
Centre Hospitalier Universitaire DijonRekrutteringFocal Acute Respiratory Distress SyndromeFrankrig
-
Hospices Civils de LyonAfsluttetAkut Respiratory Distress Syndrome (ARDS)Frankrig
-
The Second Affiliated Hospital of Chongqing Medical...Children's Hospital of Chongqing Medical University; Chongqing Medical... og andre samarbejdspartnereIkke rekrutterer endnuAcute respiratory distress syndrom | Respiratory Distress Syndrome, Akut