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HealthyPhase 1NCT00345670

Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children

A Phase 1 study testing MEDI-534 in people with Healthy, run by MedImmune LLC at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3)… Read more about this study

Who is it for?
Ages 1 year to 9 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
MEDI-534
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
12 sitesUnited States
Study dates
Jun 2006to May 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female aged 1 through 9 years old
  • In general good health
  • Seropositive for RSV (enzyme-linked immunosorbent assay [ELISA] titer > 12 U/ml) and PIV3 (hemagglutination-inhibition [HAI] titer > 1:8)
  • Subject's parent/legal representative available by telephone
  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
  • Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
  • Ability to complete the follow-up period of 6 months following dosing as required by the protocol

Who cannot join

  • Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
  • Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
  • Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
  • Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
  • Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
  • Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
Show all 21Show fewer
  • Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
  • Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
  • History of Guillain-Barré syndrome
  • Known or suspected immunodeficiency, including HIV
  • Known or suspected acute or chronic hepatitis infection
  • Living at home or attending day care with children less than or equal to 24 months of age
  • Contact with pregnant caregiver
  • Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing
  • History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc)
  • Previous medical history, or evidence, of chronic illness may compromise the safety of the subject
  • At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study
  • History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
  • Passive primary household smoking
  • Family member or household contact who is an employee of the research center with the conduct of the study
  • Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Maryland Pediatric Ambulatory Center

    Baltimore, Maryland, 21201

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Regional Clinical Research, Inc.

    Binghamton, New York, 13901

  • Pediatric Associates of Mt. Carmel, Inc.

    Cincinnati, Ohio, 45245

  • Cincinnati Children's Hospital Medical Center, Division of Infectious Disease

    Crestview Hills, Kentucky, 41017

  • Edinger Medical Group

    Fountain Valley, California, 92708

  • University Physicians Internal Medicine

    Huntington, West Virginia, 25701-3655

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Primary Physicians Research, Inc.

    Pittsburgh, Pennsylvania, 15241

  • Heart of America Research

    Shawnee, Kansas, 66216

  • Children's Hospital at Montefiore; Montefiore Medical Center

    The Bronx, New York, 10467

  • Heart of America Research

    Topeka, Kansas, 66614

Other trials in United States

About this study

Official title: A Phase I, 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 (PIV3), in Healthy RSV and PIV3 Seropositive 1-9 Year-Old Children

This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening. MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be stratified by site. This study will enroll during the RSV off season at multiple sites in the United States and Chile.

Conditions
Healthy
Being tested
MEDI-534
Keywords
Lower respiratory tract illness, RSV and PIV3 infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI-534Biological

    10:4 TCID50 of MEDI-534 intranasal spray Study Day 0

  • MEDI-534Biological

    10:5 TCID50 of MEDI-534 intranasal spray Study Day 0

  • MEDI-534Biological

    10:6 TCID50 of MEDI-534; intranasal spray

Study groups in NCT00345670
Study groupRoleWhat they receive
1ExperimentalMEDI-534
Receives: Biological: MEDI-534
2ExperimentalMEDI-534
Receives: Biological: MEDI-534
3ExperimentalMEDI-534
Receives: Biological: MEDI-534

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children

    Measured: Day 28

  2. Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing

    Measured: Day 28 post final vaccination

  3. Adverse events (AEs) from administration of study vaccine through 28 post-dosing

    Measured: Day 28 post final vaccination

  4. Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing

    Measured: Day 180

Secondary outcomes (2)

  1. To describe the immunogenicity and viral shedding of MEDI-534

    Measured: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.

  2. The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples

    Measured: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345670
Sponsor's protocol ID
MI-CP130
Status last verified
Sep 2008
First submitted
27 Jun 2006
Last updated
3 Sep 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Gomez M, Mufson MA, Dubovsky F, Knightly C, Zeng W, Losonsky G. Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children. Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.

    PubMed 19483659

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI-534 in people with Healthy, run by MedImmune LLC at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00345670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.

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