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TerminatedNCT00508651Updated Dec 30, 2011Results posted

A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

A Phase 1/2 interventional study of MEDI-560 and Placebo in Healthy, sponsored by MedImmune LLC. Terminated at 23 sites in United States. Open to participants aged 1 Month to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-30.

Sponsored by MedImmune LLC · Phase 1/2, Interventional, and Prevention

Why this study was terminated
The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Month to 11 Months
Sex
All
01

Study summary

The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10\^5 TCID50 when administered to children 6 to \< 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to \< 3 months of age regardless of baseline serostatus.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to \< 12 months of age. Three doses of MEDI-560 at a dosage level of 10\^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to \< 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo. A second 160-participant cohort of 1 to \< 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety. Participants were followed for safety through 180 days post last dose. Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus. Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus. Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.

02

Conditions studied

  • Healthy

Keywords

  • parainfluenza virus, children, vaccine
03

In context

Paramyxoviridae Infections

31 studies on the registry are indexed under Paramyxoviridae Infections; 2 are open to participants now.

This study's enrollment of 30 is below the median of 51 across 23 interventional studies indexed under Paramyxoviridae Infections.

Browse Paramyxoviridae Infections studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 11 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female whose age on the day of randomization falls within one of the two age cohorts:

    Cohort 1: 6 to \< 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to \< 3 months (> 28 days of age and not yet reached their 3rd month birthday)

  2. Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune
  3. Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation
  4. Participant is in general good health
  5. Participant's legal representative is available by telephone
  6. Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative
  7. Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
  8. Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol
  9. Participant's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol

Exclusion criteria

Exclusion Criteria:

  1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
  2. Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product
  3. Cohort 1 only: weight \< the fifth percentile for age on the day of randomization
  4. Cohort 2 only: history of low birth-weight (ie, \< 2,500 grams at birth) or weight \< fifth percentile for age on the day of randomization
  5. 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 investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
  6. Any current or expected receipt of immunosuppressive agents including steroids (≥ 2 mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the participant weighs >10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product 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
  7. History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing
  8. History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing
  9. Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing
  10. 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 dose
  11. Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose
  12. Known or suspected immunodeficiency, including human immunodeficiency virus
  13. Living in the same home or enrolled in the same classroom at day care with infants \< 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
  14. Contact with pregnant caregiver within 28 days after each dose
  15. Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose
  16. Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children \< 24 months of age
  17. History of allergic reaction to any component of the investigational product
  18. Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant
  19. Known or suspected active or chronic hepatitis infection
  20. History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
  21. A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study
  22. Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Cohort 1 MEDI-560

    MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

    Biological: MEDI-560

  • Placebo comparator
    Cohort 1 Placebo

    Placebo was a frozen preparation filled into Becton Dickinson\^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

    Biological: Placebo

Interventions

  • BiologicalMEDI-560

    MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

  • BiologicalPlacebo

    Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

06

What researchers measure

Primary outcomes

  1. 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)

  2. Number of Participants With SEs After Dose 2

    Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

  3. 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)

  4. Number of Participants With Adverse Events (AEs) After Dose 1

    Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.

    Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)

  5. Number of Participants With AEs After Dose 2

    Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.

    Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

  6. Number of Participants With AEs After Dose 3

    Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.

    Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  7. Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1

    Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)

  8. Number of Participants With MA-LRIs After Dose 2

    Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

  9. Number of Participants With MA-LRIs After Dose 3

    Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  10. Number of Participants With Serious Adverse Events (SAEs) After Dose 1

    Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)

  11. Number of Participants With SAEs After Dose 2

    One participant had event of pneumonia after Dose 2.

    Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

  12. Number of Participants With SAEs After Dose 3

    Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  13. Number of Participants With Significant New Medical Conditions (SNMCs)

    A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

    Time frame: Day 0 through 180 days after final dose

Secondary outcomes

  1. Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.

  2. Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 7-10 after Dose 1 (Dose 1 was on Day 0)

  3. Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 12-18 after Dose 1 (Dose 1 was on Day 0)

  4. Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)

  5. 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)

  6. Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)

  7. Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)

  8. Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)

  9. Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)

  10. Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  11. Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  12. Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  13. Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.

    Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

    Time frame: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  14. Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1

    Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

    Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)

  15. Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2

    Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

    Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)

  16. Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3

    Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

    Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

  17. Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable

    A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.

    Time frame: Day 0 after Dose 1 to 180 days after the final dose

  18. Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable

    A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.

    Time frame: Day 0 after Dose 1 to 180 days after the final dose

  19. Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline

    Pre-dose GMT of HAI antibody to HPIV3

    Time frame: Baseline (Day 0 prior to Dose 1)

  20. Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1

    Post-Dose 1 GMT of HAI antibody to HPIV3

    Time frame: Day 28-34 after Dose 1 (Dose 1 was on Day 0)

  21. Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2

    Post-Dose 2 GMT of HAI antibody to HPIV3

    Time frame: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)

  22. Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3

    Post-Dose 3 GMT of HAI antibody to HPIV3

    Time frame: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

07

Results

Posted Dec 30, 2011
Limitations and caveats
Cohort 2 was not enrolled due to a sponsor decision.

Participant flow

Participants 6 to \< 12 months of age were screened prior to randomization at 8 sites in the USA. The first and last days of informed consent were 07Nov2007 and 30Jun2008, respectively. No participants were screened for Cohort 2 (1 to \< 3 months of age) because the study was closed prior to enrollment into Cohort 2 for reasons other than safety.

Participant flow — Overall Study
MilestoneCohort 1 MEDI-560Cohort 1 Placebo
Started2010
Completed168
Not completed42
Withdrew: Lost to follow-up31
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryNumber of Participants With Solicited Adverse Events (SEs) After Dose 1
Time frame:
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
runny/stuffy nose146
cough135
drowsiness82
irritability/fussiness62
fever greater than or equal to 100.4° F31
fever greater than or equal to 101.5° F10
fever greater than or equal to 103.2° F10
fever greater than or equal to 104.9° F00
loss of appetite/decreased urine output32
oropharygeal inflammation (laryngitis)10
epistaxis00
PrimaryNumber of Participants With SEs After Dose 2
Time frame:
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants With SEs After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
runny/stuffy nose124
cough62
drowsiness30
irritability/fussiness82
fever greater than or equal to 100.4° F51
fever greater than or equal to 101.5° F21
fever greater than or equal to 103.2° F10
fever greater than or equal to 104.9° F00
loss of appetite/decreased urine output40
oropharygeal inflammation (laryngitis)20
epistaxis00
PrimaryNumber of Participants With SEs After Dose 3
Time frame:
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants With SEs After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
runny/stuffy nose73
cough51
drowsiness20
irritability/fussiness63
fever greater than or equal to 100.4° F30
fever greater than or equal to 101.5° F20
fever greater than or equal to 103.2° F00
fever greater than or equal to 104.9° F00
loss of appetite/decreased urine output41
oropharygeal inflammation (laryngitis)00
epistaxis00
PrimaryNumber of Participants With Adverse Events (AEs) After Dose 1

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.

Time frame:
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs) After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Tachycardia20
Conjunctivitis10
Diarrhoea31
Vomiting21
Gastroenteritis10
Otitis media30
Upper respiratory infection52
Body temperature increased10
Pharyngeal erythema10
Rhinorrhea21
Dermatitis atopic10
Rash01
PrimaryNumber of Participants With AEs After Dose 2

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.

Time frame:
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants With AEs After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Conjunctivitis20
Diarrhoea20
Vomiting10
Gastroenteritis11
Otitis media10
Upper respiratory infection82
Body temperature increased20
Pharyngeal erythema10
Rhinorrhea01
Dermatitis atopic01
Rash12
PrimaryNumber of Participants With AEs After Dose 3

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.

Time frame:
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants With AEs After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Conjunctivitis10
Diarrhoea22
Vomiting10
Otitis media10
Upper respiratory infection21
Body temperature increased10
Dermatitis atopic01
Rash01
PrimaryNumber of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Time frame:
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participant
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
participantCohort 1 MEDI-560Cohort 1 Placebo
Bronchiolitis10
Wheezing10
Pneumonia00
PrimaryNumber of Participants With MA-LRIs After Dose 2
Time frame:
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participant
Number of Participants With MA-LRIs After Dose 2
participantCohort 1 MEDI-560Cohort 1 Placebo
Bronchiolitis00
Wheezing00
Pneumonia10
PrimaryNumber of Participants With MA-LRIs After Dose 3
Time frame:
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participant
Number of Participants With MA-LRIs After Dose 3
participantCohort 1 MEDI-560Cohort 1 Placebo
Bronchiolitis00
Wheezing00
Pneumonia00
PrimaryNumber of Participants With Serious Adverse Events (SAEs) After Dose 1
Time frame:
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participant
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
participantCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Serious Adverse Events (SAEs) After Dose 100
PrimaryNumber of Participants With SAEs After Dose 2

One participant had event of pneumonia after Dose 2.

Time frame:
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants With SAEs After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With SAEs After Dose 210
PrimaryNumber of Participants With SAEs After Dose 3
Time frame:
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants With SAEs After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With SAEs After Dose 300
PrimaryNumber of Participants With Significant New Medical Conditions (SNMCs)

A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

Time frame:
Day 0 through 180 days after final dose
Reported as:
Number · participants
Number of Participants With Significant New Medical Conditions (SNMCs)
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Significant New Medical Conditions (SNMCs)00
SecondaryNumber of Participants Shedding Vaccine-like Virus at Any Time During Study Participation

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation170
SecondaryNumber of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1160
SecondaryNumber of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1130
SecondaryNumber of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 100
SecondaryNumber 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)
Reported as:
Number · participants
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1170
SecondaryNumber of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 210
SecondaryNumber of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 200
SecondaryNumber of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 200
SecondaryNumber of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 210
SecondaryNumber of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 300
SecondaryNumber of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 300
SecondaryNumber of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 300
SecondaryNumber of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.

Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.

Time frame:
Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.00
SecondaryNumber of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1

Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

Time frame:
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Number · participants
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1110
SecondaryNumber of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2

Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

Time frame:
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Number · participants
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2111
SecondaryNumber of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3

Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

Time frame:
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Number · participants
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
participantsCohort 1 MEDI-560Cohort 1 Placebo
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3102
SecondaryNumber of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable

A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.

Time frame:
Day 0 after Dose 1 to 180 days after the final dose
Reported as:
Number · samples containing vaccine-like virus
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable
samples containing vaccine-like virusCohort 1 MEDI-560Cohort 1 Placebo
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable28—
SecondaryNumber of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable

A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.

Time frame:
Day 0 after Dose 1 to 180 days after the final dose
Reported as:
Number · samples containing vaccine-like virus
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable
samples containing vaccine-like virusCohort 1 MEDI-560Cohort 1 Placebo
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable28—
SecondaryGeometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline

Pre-dose GMT of HAI antibody to HPIV3

Time frame:
Baseline (Day 0 prior to Dose 1)
Reported as:
Mean · GMT
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
GMTCohort 1 MEDI-560Cohort 1 Placebo
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline3.05 (2.2 to 4.8)NA (NA to NA)
SecondaryGeometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1

Post-Dose 1 GMT of HAI antibody to HPIV3

Time frame:
Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Reported as:
Mean · GMT
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
GMTCohort 1 MEDI-560Cohort 1 Placebo
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 117.28 (9.3 to 33.3)NA (NA to NA)
SecondaryGeometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2

Post-Dose 2 GMT of HAI antibody to HPIV3

Time frame:
Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Reported as:
Mean · GMT
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
GMTCohort 1 MEDI-560Cohort 1 Placebo
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 225.40 (11.1 to 55.7)3.17 (2.0 to 8.0)
SecondaryGeometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3

Post-Dose 3 GMT of HAI antibody to HPIV3

Time frame:
Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Reported as:
Mean · GMT
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
GMTCohort 1 MEDI-560Cohort 1 Placebo
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 342.91 (13.3 to 142.4)6.35 (2.0 to 26.9)

Adverse events

Collected over Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 MEDI-560—1/20 (5%)19/20 (95%)
Cohort 1 Placebo—0/8 (0%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventCohort 1 MEDI-560Cohort 1 Placebo
PneumoniaInfections and infestations1/200/8
Most frequent other events
Showing 10 of 34
Most frequent other events
EventCohort 1 MEDI-560Cohort 1 Placebo
Upper respiratory tract infectionInfections and infestations9/204/8
RashSkin and subcutaneous tissue disorders1/204/8
DiarrhoeaGastrointestinal disorders7/202/8
RhinorrhoeaRespiratory, thoracic and mediastinal disorders2/202/8
Dermatitis atopicSkin and subcutaneous tissue disorders1/202/8
ConjunctivitisEye disorders4/200/8
Otitis mediaInfections and infestations4/200/8
VomitingGastrointestinal disorders3/201/8
Body temperature increasedInvestigations3/200/8
GastroenteritisInfections and infestations2/201/8

Baseline characteristics

Age Continuous
Age Continuous(Months)Cohort 1 MEDI-560Cohort 1 PlaceboTotal
Mean8.94 ± 1.858.44 ± 1.208.77 ± 1.66
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 MEDI-560Cohort 1 PlaceboTotal
Female12416
Male8614
08

Study locations

23 sites
  • Children's Investigational Research Program
    Bentonville, Arkansas 72712, United States
  • Arkansas Pediatric Clinic
    Little Rock, Arkansas 72205, United States
  • Madera Family Medical Group
    Madera, California 93637, United States
  • Allergy Medical Group of the North Area
    Roseville, California 95678, United States
  • Miami Children's Hospital
    Miami, Florida 33155, United States
  • Homestead Clinical Research
    Naranja, Florida 33032, United States
  • University of South Florida College of Medicine Department of Pediatrics
    Tampa, Florida 33606, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826-1032, United States
  • Michael W. Simon, M.D.
    Lexington, Kentucky 40503, United States
  • Tulane University
    New Orleans, Louisiana 70112, United States
  • Tufts-New England Medical Center
    Boston, Massachusetts 02111, United States
  • Meridian Clinical Research LLC
    Omaha, Nebraska 68134, United States
  • Children's Lung Specialists Ltd.
    Las Vegas, Nevada 89107, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Duke Health Center- Pickett Road
    Durham, North Carolina 27705, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229-3039, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Oklahoma State University Center for Health Sciences
    Tulsa, Oklahoma 74127, United States
  • St. Luke's Hospital
    Bethlehem, Pennsylvania 18015, United States
  • Belleview Pediactric Assoc.
    Pittsburgh, Pennsylvania 15202, United States
  • Holston Medical Group
    Kingsport, Tennessee 37660, United States
  • Dixie Pediatrics
    St. George, Utah 84790, United States
  • University Physicians Internal Medicine
    Huntington, West Virginia 25701, United States
09

References and documents

Publications

  • Bernstein DI, Falloon J, Yi T. A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants. Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22. PubMed 21782874 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00508651
Lead sponsor
MedImmune LLC
First posted
Jul 30, 2007
Start date
Oct 2007
Primary completion
Apr 2009
Completion
Apr 2009
Results posted
Dec 30, 2011
Last update
Dec 30, 2011

Study contacts

Judith Falloon, MD
study director · MedImmune LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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