A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of M… (NCT00686075) | Clinical Trial Compass
CompletedPhase 1/2
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
United States1,338 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range2 Months – 23 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female whose age on the day of randomization falls within one of the two age groups:
6 to less than (\<) 24 months (more than \[\>\] 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2 2 months (+/- 4 weeks), Cohorts 3, 4, and 5
* Cohorts 1 and 2 only: Subject is seronegative to both Respiratory Syncytial Virus (RSV) and human Parainfluenza Virus Type 3 (hPIV3) at Screening
* Subject whose gestational age was greater than or equal to (\>=) 36 weeks
* Subject is in general good health with normal growth (that is, body weight greater than (\>) third percentile per world health organization \[WHO\] simplified weight-per-age field tables
* Subject's legal representative is available by telephone
* Written informed consent and Health Insurance Portability and Accountability Act (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 1-year after receipt of the first dose of study vaccine
* 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 (\>=100.4 degrees Fahrenheit \[\>=38.0 degrees Celsius\], regardless of route) or lower respiratory illness within 7 days…
What they're measuring
1
Number of Participants With Solicited Symptoms After Dose 1
Timeframe: Within 28 days after Dose 1
2
Number of Participants With Solicited Symptoms After Dose 2
Timeframe: Within 28 days after Dose 2
3
Number of Participants With Solicited Symptoms After Dose 3
Timeframe: Within 28 days after Dose 3
4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
Timeframe: Within 28 days after Dose 1
5
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
Timeframe: Within 28 days after Dose 2
6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
Timeframe: Within 28 days after Dose 3
7
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
Timeframe: Within 28 days after Dose 1
8
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2