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Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers

29. september 2011 opdateret af: Sanofi

This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.

Primary Objective:

  • To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 18 to 50 years on the day of inclusion
  • Healthy, as determined by medical history and clinical examination
  • Informed consent obtained
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit
  • For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination.

Exclusion Criteria:

  • Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern
  • For a woman, breast-feeding
  • Participation in another clinical trial in the 30 days preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Blood or blood-derived products received in the past 3 months
  • Any vaccination in the 30 days preceding the first trial vaccination
  • Vaccination planned in the 30 days following any trial vaccination
  • Known Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
  • Known thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (≥ 38.0°C [or 100.4°F]) within 72 hours of inclusion/vaccination
  • Previous vaccination in the preceding 5 years against pneumococcal disease with another vaccine
  • History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
  • Subject at high risk of pneumococcal infection during the trial
  • Subjects living in a household with children < 5 years of age
  • Antibiotic usage or upper or lower respiratory tract infection within one week before any blood draw for immunogenicity (Visits 1, 3, and 5).

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pneumococcal Vaccine Dose 1 (Low dose)
Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively.
0.5 mL, intramuscular
Eksperimentel: Pneumococcal Vaccine Dose 2 (Middle dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively.
0.5 mL, intramuscular
Eksperimentel: Pneumococcal Vaccine Dose 3 (High dose)
Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively.
0.5 mL, intramuscular

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The occurrence of solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Tidsramme: Day 0 up to Day 60 post vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
Day 0 up to Day 60 post vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity of pneumococcal vaccine after 2 vaccinations
Tidsramme: Day 0 and 30 days post vaccination
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA).
Day 0 and 30 days post vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Medical Director, Sanofi Pasteur Ltd.

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.

Hjælpsomme links

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

1. februar 2007

Primær færdiggørelse (Faktiske)

1. august 2007

Studieafslutning (Faktiske)

1. august 2007

Datoer for studieregistrering

Først indsendt

28. september 2011

Først indsendt, der opfyldte QC-kriterier

29. september 2011

Først opslået (Skøn)

30. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2011

Sidst verificeret

1. september 2011

Mere information

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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