| June 26, 2007 |
| July 24, 2009 |
| May 2007 |
| November 2009 (final data collection date for primary outcome measure) |
| 1-Incidence of solicited symptoms from administration of study vaccine through 28 days following each dose. [ Time Frame: Through study day 28 ] [ Designated as safety issue: No ] |
- 1-Incidence of solicited 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 ]
- 2-Incidence of unsolicited adverse events from administration of study vaccine through 28 days following each dose [ Time Frame: 28 days following each dose ]
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| Complete list of historical versions of study NCT00493285 on ClinicalTrials.gov Archive Site |
| 1-Incidence and magnitude of vaccine-like viral shedding of MEDI-534. [ Time Frame: At study days 7, 12, and 28 after each dose for each treatment group ] [ Designated as safety issue: No ] |
| 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 ] |
| |
| Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age |
| 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 RSV and PIV3 disease in young infants. |
The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10 to 4, 10 to 5, or 10 to 6 TCID50 when administered to RSV and PIV3 seronegative children 6 to <24 months of age. |
| Phase I |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
- Respirovirus Infections
- Respiratory Syncytial Virus Infections
- Parainfluenza Virus 3, Human
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| Biological: MEDI-534 |
- Active Comparator: MEDI-534 at 10:4 TCID50 at 0, 2, and 4 months (Nasal spray)
- Active Comparator: MEDI-534 at 10:5 TCID50 at 0, 2, and 4 months (Nasal Spray)
- Active Comparator: MEDI-534 at 10:6 TCID50 at 0, 2, and 4 months (Nasal Spray)
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| |
| |
| Active, not recruiting |
| 49 |
| April 2010 |
| November 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 6 Months to 23 Months |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00493285 |
| Elissa Malkin, D.O., MedImmune LLC |
| MI-CP149 |
| MedImmune LLC |
|
| Study Director: |
Elissa Malkin, D.O. |
MedImmune LLC |
|
|
| MedImmune LLC |
| July 2009 |