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

13. Juli 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

49

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Monate bis 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 1
MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray)
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Aktiver Komparator: 2
MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Aktiver Komparator: 3
MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray)
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Biologisch: MEDI-534
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Adverse Events (AEs) After Dose 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

MedImmune LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2007

Primärer Abschluss (Tatsächlich)

1. November 2009

Studienabschluss (Tatsächlich)

1. April 2010

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2007

Zuerst gepostet (Schätzen)

28. Juni 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

19. Juli 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2012

Zuletzt verifiziert

1. Juli 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MI-CP149

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