Clinical Trial: Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Vaccin
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: MedImmune LLC
Current Primary Outcome:
- Number of Participants With Solicited Adverse Events (SEs) After Dose 1 [ Time Frame: 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.
- Number of Participants With SEs After Dose 2 [ Time Frame: 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.
- Number of Participants With SEs After Dose 3 [ Time Frame: 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.
- Number of Participants With Adverse Events (AEs) After Dose 1 [ Time Frame: 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.
- Number of Participants With AEs After Dose 2 [ Time Frame: 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.
- Number of Participants With
Original Primary Outcome:
- 1-Incidence of solicited adverse events from administration of study vaccine through 28 days following each dose [ Time Frame: 28 days following each dose ]
- 2-Incidence of unsolicited adverse events from administration of study vaccine through 28 days following each dose [ Time Frame: 28 days following each dose ]
- 3-Incidence of MA-LRIs from administration of study vaccine through 28 days following each dose [ Time Frame: 28 days following each dose ]
- 4-Incidence of SAEs from administration of study vaccine through 28 days following each dose [ Time Frame: 28 days following each dose ]
- 5-Description of SNMCs from administration of study vaccine through the end of the RSV season or 180 days after the final dose of vaccine, whichever is later [ Time Frame: 180 days after the final dose ]
Current Secondary Outcome:
- Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 [ Time Frame: 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.
- Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 [ Time Frame: 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.
- Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 [ Time Frame: 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.
- Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 [ Time Frame: 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.
- Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 [ Time Frame: 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.
- Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline [ Time Frame: 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.
- Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 [ Time Frame: Day 28-34 after Dose 1 (Dose 1 was on Day 0) ]Post dose GMT of serum antibody response to RSV as measured by microneutralizatio
Original Secondary Outcome: 1-Incidence of viral shedding of MEDI-534 will be determined after each vaccine dose by culturing nasal wash material obtained at Days 7, 12, and 28 after each dose and identifying and quantifying vaccine virus isolated. [ Time Frame: After dose obtained on days 7, 12 and 28 ]
Information By: MedImmune LLC
Dates:
Date Received: June 26, 2007
Date Started: July 2007
Date Completion:
Last Updated: July 13, 2012
Last Verified: July 2012