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A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers

20. september 2013 opdateret af: Nuron Biotech Inc.

A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®

Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.

Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.

Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

220

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • California
      • Oakland, California, Forenede Stater, 94611
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004

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

1 år til 1 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Written informed consent obtained from the parent or guardian of the subject
  2. Male or female subjects 12-15 months of age at the time of booster vaccination, who had previously received complete primary vaccination series with a licensed Hib product and Prevnar 13® in accordance with the FDA approved labels.
  3. Subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol
  4. Subjects free of obvious health problems as established by medical history and clinical examination before entering the study

Exclusion Criteria:

  1. Previous booster vaccination against Hib and/or Prevnar 13®
  2. Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.
  3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 28 days after administration of study vaccines (before the blood draw at Visit 2).
  4. Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study.
  5. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination.
  6. Early pre-term birth (delivery before 32 weeks).
  7. Major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc.
  8. Concurrent participation in another clinical study at any time during the study period or within the previous 6 months in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product, formula, or device)
  9. Presence of a moderate or severe illness with or without fever at the time of vaccination (fever is defined as a temperature of ≥ 38.0C [100.4F]).
  10. Known history of thrombocytopenia or any coagulation disorder.
  11. Known hypersensitivity to any of the components of the vaccines.
  12. Known hypersensitivity to latex.
  13. The subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at Visit 1

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NU300 and Prevnar 13
NU300 at a single dose of 0.5 mL IM
Aktiv komparator: ActHIB and Prevnar 13
ActHIB at a dose of 0.5 ml IM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
safety and efficacy
Tidsramme: one month

Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®, over a 28 day period following injection

Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.

one month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
Tidsramme: one month
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection
one month

Samarbejdspartnere og efterforskere

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

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. marts 2013

Primær færdiggørelse (Forventet)

1. januar 2014

Studieafslutning (Forventet)

1. april 2014

Datoer for studieregistrering

Først indsendt

19. november 2012

Først indsendt, der opfyldte QC-kriterier

21. november 2012

Først opslået (Skøn)

22. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

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 Smitsom sygdom

Kliniske forsøg med Prevnar 13

Abonner