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Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant (ProQuad®)

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ClinicalTrials.gov Identifier: NCT02687763
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Twombley, Medical University of South Carolina

Brief Summary:
A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney)

Condition or disease Intervention/treatment Phase
RENAL INSUFFICIENCY, CHRONIC LIVER FAILURE, ACUTE HEART DISEASE Biological: ProQuad Early Phase 1

Detailed Description:

Primary Aim:

To measure the antibody response to ProQuad® vaccination given earlier than the current recommended age in patients from the age of 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five years. These subjects would not reach the recommended ages to receive the vaccine before the transplant.

Hypothesis:

The Investigator proposes the hypothesis that the proposed study population will mount a clinically significant response to two (2) doses of the ProQuad® vaccine.

Primary Endpoint:

With respect to expected outcomes, the work proposed is expected to provide tools for optimizing the ProQuad® vaccination strategy in this population.

Secondary Aim:

To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).

Hypothesis :

The Investigator proposes the hypothesis that the study population will have similar safety profiles compared to children who receive the vaccine at the recommended ages.

Secondary Endpoint:

The secondary outcome measure is represented by the children in the study having either no adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination report card that the parents/legal guardians of the participants in the study will complete for their child for 7 days after he/she receives each dose of the vaccine.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multisite Study to Evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® Vaccination in Pediatric Patients 6-24 Months of Age Who Are Being Considered and/or Evaluated for Any Solid Organ Transplant
Study Start Date : December 2015
Actual Primary Completion Date : November 3, 2016
Actual Study Completion Date : November 3, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Open Label. Two 0.5-mL doses of ProQuad® will be given by intramuscular injection at least 30 days but no more than 365 days apart..
Biological: ProQuad

2) Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:

  1. to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
  2. to participate in the three (3) antibody titer blood draws.




Primary Outcome Measures :
  1. Varicella IgG Antibody Titer ≥ 1.1 IU/ml [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Percentage of Participants with Varicella IgG Antibody Titer ≥ 1.1 IU/ml: at least 30 days to less than 365 days post vaccination.

  2. Measles IgG Antibody Titer ≥ 30AU/ml [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Percentage of Participants with post vaccination Measles IgG Antibody Titer ≥ 30AU/ml: at least 30 days to less than 365 days post vaccination.

  3. Mumps IgG Antibody Titer ≥ 11AU/ml [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Percentage of Participants tested for Mumps IgG Antibody Titer ≥ 11AU/ml: at least 30 days to less than 365 days post vaccination.

  4. Rubella IgG Antibody Titer ≥ 15 IU/mL [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Percentage of Participants tested for Rubella IgG Antibody Titer ≥ 15 IU/mL: at least 30 days to less than 365 days post vaccination.


Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Varicella Antibody [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Geometric Mean Titer (GMT) of Varicella Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.

  2. Geometric Mean Titer (GMT) of Measles Antibody [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Geometric Mean Titer (GMT) of Measles Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.

  3. Geometric Mean Titer (GMT) of Mumps Antibody [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Geometric Mean Titer (GMT) of Mumps Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.

  4. Geometric Mean Titer (GMT) of Rubella Antibody [ Time Frame: "at least 30 days to less than 365 days post vaccination" ]
    Geometric Mean Titer (GMT) of Rubella Antibody participating subjects at three different points in time. Antibody titers will be reported as geometric mean concentrations (GMCs) with 95% confidence intervals (CIs). Responses to historical controls will be compared by Student paired or unpaired t test and Fisher exact test. P < .05 will be considered statistically significant.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Parent and/or legal guardian willing and able to give informed consent.
  2. Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:

    • to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
    • to participate in the three (3) antibody titer blood draws.

Exclusion Criteria:

  1. History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
  2. Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
  3. Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
  4. Any condition which causes the investigator to determine that the subject is not appropriate to enroll.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687763


Locations
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United States, South Carolina
Medical University of South Carolina, Pediatric Nephrology
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Study Director: Katherine Twombley, MD Medical University of South Carolina

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Responsible Party: Katherine Twombley, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02687763     History of Changes
Other Study ID Numbers: Pro25854
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Katherine Twombley, Medical University of South Carolina:
vaccines
ProQuad
immunosuppressed
solid organ transplant
MMRV
Additional relevant MeSH terms:
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Liver Failure
Liver Failure, Acute
Renal Insufficiency
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases