- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00707798
Evaluation of Pneumococcal Vaccine Formulations in Young Adults
9. maj 2017 opdateret af: GlaxoSmithKline
A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults.
Subjects will be vaccinated twice with an interval of two months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This amendment was due to
- The addition of secondary endpoints for safety. The collection of data related to these secondary safety endpoints was already planned and the corresponding statistical analyses were described in the statistical section.
- The addition of an exclusion criterion regarding the administration of immunoglobulins and blood products. It is already included in the elimination criteria section. It impacts only immunogenicity.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
157
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Gent, Belgien, 9000
- GSK Investigational Site
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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
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 18 and 40 years old at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
- If the subject is female, and of child-bearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.
Exclusion Criteria:
- Previous vaccination against Streptococcus pneumoniae.
- Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
- 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 or participation to another pharmaceutical/vaccine study.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered > 7 days preceding or > 7 days following each vaccine dose (after collection of 7-day safety data).
- Bacterial pneumonia within 3 years prior to 1st vaccination.
- Invasive pneumococcal disease (IPD) within 3 years prior to 1st vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of thrombocytopenia or bleeding disorder.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Current serious neurologic or mental disorders.
- Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
- All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Acute disease at the time of enrolment/vaccination.
- Physical examination positive for acrocyanosis, jaundice, splenomegaly.
- Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic , hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
- Laboratory evidence of haematological abnormalities.
- Laboratory evidence of biochemical abnormalities
- 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.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Other conditions that the principal 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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Formulering 3
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Eksperimentel: Formulering 4
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Eksperimentel: Formulering 1
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Eksperimentel: Formulering 2
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Eksperimentel: Formulering 5
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Eksperimentel: Formulering 6
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Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
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Aktiv komparator: 23 valent pneumokokvaccine
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One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Forekomst af enhver vaccinerelateret og grad 3 anmodet lokale og generelle bivirkninger
Tidsramme: I løbet af en 7-dages opfølgningsperiode efter hver vaccinedosis
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I løbet af en 7-dages opfølgningsperiode efter hver vaccinedosis
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Forekomst af enhver vaccinerelaterede og grad 3 uønskede bivirkninger
Tidsramme: I en 31-dages opfølgningsperiode efter hver vaccinedosis
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I en 31-dages opfølgningsperiode efter hver vaccinedosis
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Occurrence of any vaccine related serious adverse events (SAE)
Tidsramme: From Visit 1 to study conclusion
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From Visit 1 to study conclusion
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Occurrence of any grade 3 laboratory abnormalities
Tidsramme: During a 7-day follow up period after each vaccine dose
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During a 7-day follow up period after each vaccine dose
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Forekomst af uønskede uønskede hændelser
Tidsramme: I en 31-dages opfølgningsperiode efter hver vaccinedosis
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I en 31-dages opfølgningsperiode efter hver vaccinedosis
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Anti-pneumokok- og anti-NTHi-kandidatvaccineantigener
Tidsramme: På dag 0, 30 og 90
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På dag 0, 30 og 90
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Occurrence of any solicited local and general adverse events
Tidsramme: During a 7-day follow up period after each vaccine dose.
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During a 7-day follow up period after each vaccine dose.
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Occurrence of any haematological, biochemical, or urinary abnormalities
Tidsramme: At 1 and 7 days after each vaccine dose
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At 1 and 7 days after each vaccine dose
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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)
30. juni 2008
Primær færdiggørelse (Faktiske)
15. januar 2009
Studieafslutning (Faktiske)
15. januar 2009
Datoer for studieregistrering
Først indsendt
30. juni 2008
Først indsendt, der opfyldte QC-kriterier
30. juni 2008
Først opslået (Skøn)
1. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 111651
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
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Formular til informeret samtykke
Informations-id: 111651Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokol
Informations-id: 111651Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 111651Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasætspecifikation
Informations-id: 111651Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 111651Oplysningskommentarer: 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 .
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