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Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age (CP149)

13 luglio 2012 aggiornato da: MedImmune LLC

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10^4, 10^5, or 10^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

49

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arkansas
      • Conway, Arkansas, Stati Uniti, 72033
        • Arkansas Pediatric Research Division
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Arkansas Pediatric Clinic
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • The Children's Hospital
    • Florida
      • Miami, Florida, Stati Uniti, 33155
        • Miami Children's Hospital
      • Palm Beach Gardens, Florida, Stati Uniti, 33410
        • Pediatric Partners
    • Georgia
      • Dalton, Georgia, Stati Uniti, 30721
        • North Georgia Clinical Research Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • University Consultants in Allergy and Immunology
      • Chicago, Illinois, Stati Uniti, 61614
        • Children's Memorial Hospital
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland, Baltimore
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts-New England Medical Center
    • Missouri
      • Bridgeton, Missouri, Stati Uniti, 63044
        • Craig A. Spiegel, MD
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68134
        • Meridian Clinical Research, LLC
    • New York
      • Binghamton, New York, Stati Uniti, 13901
        • United Medical Associates
      • Mineola, New York, Stati Uniti, 11501
        • Withrop University Hospital
      • Syracuse, New York, Stati Uniti, 13210
        • SUNY Upstate Medical University
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Stati Uniti, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Stati Uniti, 44106
        • University Hospitals Case Medical Center
      • Toledo, Ohio, Stati Uniti, 43608
        • St. Vincent Mercy Medical Center Mercy Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15241
        • Primary Physicians Research, Inc.
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57117
        • Sanford Children's Specialty Clinic
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • University of Texas Health Science Center of Houston Medical School
    • Utah
      • Ogden, Utah, Stati Uniti, 84405
        • Bear Care Pediatrics
      • South Jordan, Utah, Stati Uniti, 84095
        • Copperview Medical Center
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23219
        • Virginia Commonwealth University
      • Vienna, Virginia, Stati Uniti, 22180
        • Advanced Pediatrics
    • Washington
      • Spokane, Washington, Stati Uniti, 99202
        • Rockwood Clinic Research Center
    • West Virginia
      • Huntington, West Virginia, Stati Uniti, 25701
        • Marshall University Joan C. Edwards School of Medicine
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Health Science Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 1 anno (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male or female whose age on the day of randomization is 6 to <24 months (reached 6th month birthday and not yet reached 2nd year birthday)
  • Subject is seronegative to both RSV and PIV3 at screening
  • Subject was the product of normal full term pregnancy (defined as >36 weeks gestation)
  • Subject is in general good health
  • Subject's legal representative is available by telephone
  • Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
  • Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
  • Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later
  • Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol

Exclusion Criteria:

  • Any fever (equal to or greater than 100.4°F [equal to or greater than 38.0°C], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization
  • Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
  • Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
  • Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs >10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator
  • History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing
  • History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
  • Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing
  • Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
  • Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
  • Known or suspected immunodeficiency, including HIV
  • Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study)
  • Contact with pregnant caregiver
  • A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
  • A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
  • History of allergic reaction to any component of the study vaccine
  • Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
  • Known or suspected active or chronic hepatitis infection
  • History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
  • Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
  • Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray)
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Comparatore attivo: 2
MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Comparatore attivo: 3
MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologico: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events (AEs) After Dose 1
Lasso di tempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With AEs After Dose 2
Lasso di tempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With AEs After Dose 3
Lasso di tempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Lasso di tempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SEs After Dose 2
Lasso di tempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SEs After Dose 3
Lasso di tempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)
Lasso di tempo: Days 0 to 180 days after final dose or the end of the RSV season, whichever was later
An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.
Days 0 to 180 days after final dose or the end of the RSV season, whichever was later
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: Days 0-28 after any dose
Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.
Days 0-28 after any dose
Number of Participants With Significant New Medical Conditions (SNMCs)
Lasso di tempo: Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Lasso di tempo: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Lasso di tempo: Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Lasso di tempo: Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Lasso di tempo: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Lasso di tempo: Days 0-34 after Dose 1 (Dose 1 was on Day 0)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 0-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Lasso di tempo: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Lasso di tempo: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Lasso di tempo: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Lasso di tempo: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Lasso di tempo: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Lasso di tempo: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Lasso di tempo: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3
Lasso di tempo: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline
Lasso di tempo: Baseline (Day 0 prior to Dose 1)
Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1
Lasso di tempo: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2
Lasso di tempo: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3
Lasso di tempo: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline
Lasso di tempo: Baseline (Day 0 prior to Dose 1)
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1
Lasso di tempo: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2
Lasso di tempo: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3
Lasso di tempo: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Seroresponse to RSV 28 Days After Dose 1
Lasso di tempo: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Seroresponse to RSV 28 Days After Dose 2
Lasso di tempo: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Seroresponse to RSV 28 Days After Dose 3
Lasso di tempo: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 1
Lasso di tempo: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 2
Lasso di tempo: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 3
Lasso di tempo: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MedImmune LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2007

Completamento primario (Effettivo)

1 novembre 2009

Completamento dello studio (Effettivo)

1 aprile 2010

Date di iscrizione allo studio

Primo inviato

26 giugno 2007

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2007

Primo Inserito (Stima)

28 giugno 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 luglio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2012

Ultimo verificato

1 luglio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MI-CP149

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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