- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01193907
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
16 december 2013 uppdaterad av: Novartis
A Phase 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age
This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
88
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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Wilrijk (Antwerp)
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Antwerp, Wilrijk (Antwerp), Belgien, 2610
- Center for the Evaluation of Vaccination (CEV)
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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:
- Males and females of age ≥18 to ≤40 years.
- Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
- If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.
Exclusion Criteria:
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
- Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
- Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Individuals who have any malignancy or lymphoproliferative disorder.
- Individuals with history of allergy to vaccine components.
- Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines).
- Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine.
- Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
- Individuals who are part of study personnel or close family members to the personnel conducting this study.
- Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
- BMI > 35 kg/m2.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
- Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
- Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
- Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
- Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
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: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: NVGH Vi-CRM197 conjugate vaccine 12.5 mcg
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
1 dose of 0.5 mL
|
Experimentell: NVGH Vi-CRM197 conjugate vaccine 5 mcg
1 dose of 0.5 mL containing 5 mcg of Vi-CRM
|
1 dose of 0.5 mL
|
Experimentell: NVGH Vi-CRM197 conjugate vaccine 1.25 mcg
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
1 dose of 0.5 mL
|
Aktiv komparator: Typherix
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
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1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Antal försökspersoner som rapporterar negativa händelser
Tidsram: Under 28-dagarsperioden efter vaccination
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Under 28-dagarsperioden efter vaccination
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|
Number of Subjects Reporting Any Post Immunization Reactions
Tidsram: During the 7-day period after vaccination
|
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue
|
During the 7-day period after vaccination
|
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
Tidsram: At 28 days after vaccination
|
At 28 days after vaccination
|
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Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Tidsram: At 28 days after vaccination
|
At 28 days after vaccination
|
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
1 oktober 2010
Primärt slutförande (Faktisk)
1 november 2010
Avslutad studie (Faktisk)
1 november 2010
Studieregistreringsdatum
Först inskickad
1 september 2010
Först inskickad som uppfyllde QC-kriterierna
1 september 2010
Första postat (Uppskatta)
2 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 januari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 december 2013
Senast verifierad
1 december 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H01_04TP
- 2010-021874-12 (EudraCT-nummer)
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 .
Kliniska prövningar på NVGH Vi-CRM197 12.5 mcg
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NovartisAvslutad
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NovartisAvslutad