- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00707798
Evaluation of Pneumococcal Vaccine Formulations in Young Adults
9 maj 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
157
Fas
- Fas 1
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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Gent, Belgien, 9000
- 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
18 år till 40 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
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: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: 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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Experimentell: 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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Experimentell: 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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Experimentell: 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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Experimentell: 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 pneumokockvaccin
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Förekomst av vaccinrelaterade och grad 3 efterfrågade lokala och allmänna biverkningar
Tidsram: Under en 7-dagars uppföljningsperiod efter varje vaccindos
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Under en 7-dagars uppföljningsperiod efter varje vaccindos
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Förekomst av eventuella vaccinrelaterade och oönskade biverkningar av grad 3
Tidsram: Under en 31-dagars uppföljningsperiod efter varje vaccindos
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Under en 31-dagars uppföljningsperiod efter varje vaccindos
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Occurrence of any vaccine related serious adverse events (SAE)
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
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Förekomst av oönskade biverkningar
Tidsram: Under en 31-dagars uppföljningsperiod efter varje vaccindos
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Under en 31-dagars uppföljningsperiod efter varje vaccindos
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Anti-pneumokock- och anti-NTHi-kandidatvaccinantigener
Tidsram: På dag 0, 30 och 90
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På dag 0, 30 och 90
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Occurrence of any solicited local and general adverse events
Tidsram: 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
Tidsram: 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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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 (Faktisk)
30 juni 2008
Primärt slutförande (Faktisk)
15 januari 2009
Avslutad studie (Faktisk)
15 januari 2009
Studieregistreringsdatum
Först inskickad
30 juni 2008
Först inskickad som uppfyllde QC-kriterierna
30 juni 2008
Första postat (Uppskatta)
1 juli 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 111651
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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Informerat samtycke
Informationsidentifierare: 111651Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informationsidentifierare: 111651Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 111651Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 111651Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 111651Informationskommentarer: 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 .
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