Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age (CP149)
13. července 2012 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
49
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Arkansas
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Conway, Arkansas, Spojené státy, 72033
- Arkansas Pediatric Research Division
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Little Rock, Arkansas, Spojené státy, 72205
- Arkansas Pediatric Clinic
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- The Children's Hospital
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Florida
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Miami, Florida, Spojené státy, 33155
- Miami Children's Hospital
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Palm Beach Gardens, Florida, Spojené státy, 33410
- Pediatric Partners
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Georgia
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Dalton, Georgia, Spojené státy, 30721
- North Georgia Clinical Research Center
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- University Consultants in Allergy and Immunology
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Chicago, Illinois, Spojené státy, 61614
- Children's Memorial Hospital
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- University of Maryland, Baltimore
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02111
- Tufts-New England Medical Center
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Missouri
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Bridgeton, Missouri, Spojené státy, 63044
- Craig A. Spiegel, MD
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Nebraska
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Omaha, Nebraska, Spojené státy, 68134
- Meridian Clinical Research, LLC
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New York
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Binghamton, New York, Spojené státy, 13901
- United Medical Associates
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Mineola, New York, Spojené státy, 11501
- Withrop University Hospital
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Syracuse, New York, Spojené státy, 13210
- SUNY Upstate Medical University
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Ohio
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Cincinnati, Ohio, Spojené státy, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Spojené státy, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, Spojené státy, 44106
- University Hospitals Case Medical Center
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Toledo, Ohio, Spojené státy, 43608
- St. Vincent Mercy Medical Center Mercy Children's Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15241
- Primary Physicians Research, Inc.
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57117
- Sanford Children's Specialty Clinic
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Tennessee
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Nashville, Tennessee, Spojené státy, 37232
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, Spojené státy, 77030
- University of Texas Health Science Center of Houston Medical School
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Utah
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Ogden, Utah, Spojené státy, 84405
- Bear Care Pediatrics
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South Jordan, Utah, Spojené státy, 84095
- Copperview Medical Center
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Virginia
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Richmond, Virginia, Spojené státy, 23219
- Virginia Commonwealth University
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Vienna, Virginia, Spojené státy, 22180
- Advanced Pediatrics
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Washington
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Spokane, Washington, Spojené státy, 99202
- Rockwood Clinic Research Center
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West Virginia
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Huntington, West Virginia, Spojené státy, 25701
- Marshall University Joan C. Edwards School of Medicine
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Morgantown, West Virginia, Spojené státy, 26506
- West Virginia University Health Science Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
6 měsíců až 1 rok (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 1
MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray)
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Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
|
|
Aktivní komparátor: 2
MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray)
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Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
|
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Aktivní komparátor: 3
MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray)
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Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Časové okno: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With AEs After Dose 2
Časové okno: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With AEs After Dose 3
Časové okno: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Časové okno: 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.
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
|
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Number of Participants With SEs After Dose 2
Časové okno: 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.
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
|
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Number of Participants With SEs After Dose 3
Časové okno: 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.
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
|
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Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)
Časové okno: 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.
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Days 0 to 180 days after final dose or the end of the RSV season, whichever was later
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Number of Participants With Serious Adverse Events (SAEs)
Časové okno: Days 0-28 after any dose
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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.
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Days 0-28 after any dose
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Number of Participants With Significant New Medical Conditions (SNMCs)
Časové okno: Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later
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A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
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Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Časové okno: 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.
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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.
|
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Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Časové okno: 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)
|
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Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Časové okno: Days 12-18 after Dose 1 (Dose 1 was on Day 0)
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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)
|
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Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Časové okno: 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.
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Days 28-34 after Dose 1 (Dose 1 was on Day 0)
|
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Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2007
Primární dokončení (Aktuální)
1. listopadu 2009
Dokončení studie (Aktuální)
1. dubna 2010
Termíny zápisu do studia
První předloženo
26. června 2007
První předloženo, které splnilo kritéria kontroly kvality
27. června 2007
První zveřejněno (Odhad)
28. června 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
19. července 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. července 2012
Naposledy ověřeno
1. července 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MI-CP149
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