Clinical Trial: A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated I

Brief Summary: Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.

Detailed Summary: This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at 10^5 or 10^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative children 6 to <24 months of age and at dosages of 10^4, 10^5 or 10^6 TCID50 in unscreened infants 2 months of age.
Sponsor: MedImmune LLC

Current Primary Outcome:

  • Number of Participants With Solicited Symptoms After Dose 1 [ Time Frame: Within 28 days after Dose 1 ]
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
  • Number of Participants With Solicited Symptoms After Dose 2 [ Time Frame: Within 28 days after Dose 2 ]
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
  • Number of Participants With Solicited Symptoms After Dose 3 [ Time Frame: Within 28 days after Dose 3 ]
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1 [ Time Frame: Within

    Original Primary Outcome: Incidence of solicited symptoms from administration of study vaccine through 28 days following each dose [ Time Frame: Through study day 28 ]

    Current Secondary Outcome:

    • Number of Participants Who Shed Vaccine-Type Virus [ Time Frame: 7, 12 and 28 days after Dose 1, 2 and 3 ]
      Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
    • Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3 [ Time Frame: Day 28 after Dose 3 ]
      Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
    • Genotypic Stability of Recovered Vaccine-Type Virus [ Time Frame: Within 28 days after any dose ]
      Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
    • Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization [ Time Frame: Day 0 to Day 365 ]
      An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
    • Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization [ Time Frame: Day 0 to Day 365 ]
      An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
    • Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization [ Time Frame: Day 0 to Day 365 ]
      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.


    Original Secondary Outcome: Incidence and magnitude of vaccine-like viral shedding of MEDI-534 Days [ Time Frame: At study days 7, 12, and 28 after each dose for each treatment group ]

    Information By: MedImmune LLC

    Dates:
    Date Received: May 23, 2008
    Date Started: June 2008
    Date Completion:
    Last Updated: September 22, 2014
    Last Verified: September 2014