Phase 2 N=720 Randomized Double-blind Treatment

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00686075 ↗

Enrolled (actual)

720

Serious AEs

5.5%

Results posted

Sep 2014

Primary outcome: Primary: Number of Participants With Solicited Symptoms After Dose 1 — 65; 68; 61; 59 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MEDI-534, Cohort 1 (Biological); Placebo, Cohort 1 (Other); MEDI-534, Cohort 2 (Biological); Placebo, Cohort 2 (Other); MEDI-534, Cohort 3 (Biological); Placebo, Cohort 3 (Other); MEDI-534, Cohort 4 (Biological); Placebo, Cohort 4 (Other); MEDI-534, Cohort 5 (Biological); Placebo, Cohort 5 (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: MedImmune LLC
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Solicited Symptoms After Dose 1	65; 68; 61; 59; 27; 24	—
PRIMARY Number of Participants With Solicited Symptoms After Dose 2	50; 53; 53; 45; 12; 19	—
PRIMARY Number of Participants With Solicited Symptoms After Dose 3	41; 45; 48; 45; 20; 17	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1	51; 51; 47; 35; 15; 15	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2	31; 41; 31; 27; 9; 10	—
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3	34; 35; 33; 25; 11; 10	—
PRIMARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2	1; 0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3	0; 1; 0; 0; 1; 0	—
PRIMARY Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1	2; 2; 4; 4; 0; 0	—
PRIMARY Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2	3; 3; 1; 3; 1; 2	—
PRIMARY Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3	3; 0; 7; 3; 2; 2	—
SECONDARY Number of Participants Who Shed Vaccine-Type Virus	33; 0; 41; 0; 22; 0	—
SECONDARY Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3	29.5; 17.6; 36.0; 25.5; 15.8; 5.3	—
SECONDARY Genotypic Stability of Recovered Vaccine-Type Virus	77; 67; 54; 1; 135; 110	—
SECONDARY Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization	8; 5; 12; 10; 3; 4	—
SECONDARY Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization	0; 0; 1; 1; 0; 0	—
SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization	6; 5; 5; 1; 1; 2	—

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.

Eligibility Criteria

Inclusion Criteria

Male or female whose age on the day of randomization falls within one of the two age groups:

6 to less 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 prior to randomization
Moderate or severe nasal congestion that in the investigator's opinion could interfere with intranasal delivery of study vaccine
Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
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 for the systemic treatment of common childhood symptoms (that is, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator
Any current or expected receipt of immunosuppressive agents including steroids (>=2 milligram per kilogram [mg/kg] per day of prednisone or its equivalent, or >=20 milligram per day [mg/day] if the subject weighs >10 kilogram [kg], given daily or on alternate days for >=14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for >=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 the protocol-specified blood collection at 28 days after final study dosing
History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing
Receipt of any live virus vaccine (excluding oral polio vaccine and 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 (that is, non-live) vaccine or oral polio 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 human immunodeficiency virus (HIV) infection
Expected to be living in the same home or enrolled in the same classroom at day care with infants <6 months within 28 days after each dose
Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study)
Expected contact with a pregnant caregiver within 28 days after each dose
A household contact who is im

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Data sourced from ClinicalTrials.gov (NCT00686075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.