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

NCT02687763 | Completed Early Phase 1

• 1 other identifier: Pro25854
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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)

Conditions

RENAL INSUFFICIENCY, CHRONIC; LIVER FAILURE, ACUTE; HEART DISEASE

Keywords

vaccines; ProQuad; immunosuppressed; solid organ transplant; MMRV

Outcome Measures

Primary Outcomes (4)

• Varicella IgG Antibody Titer ≥ 1.1 IU/ml

  Percentage of Participants with Varicella IgG Antibody Titer ≥ 1.1 IU/ml: at least 30 days to less than 365 days post vaccination.

  "at least 30 days to less than 365 days post vaccination"

• Measles IgG Antibody Titer ≥ 30AU/ml

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

  "at least 30 days to less than 365 days post vaccination"

• Mumps IgG Antibody Titer ≥ 11AU/ml

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

  "at least 30 days to less than 365 days post vaccination"

• Rubella IgG Antibody Titer ≥ 15 IU/mL

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

  "at least 30 days to less than 365 days post vaccination"

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of Varicella Antibody

  "at least 30 days to less than 365 days post vaccination"

• Geometric Mean Titer (GMT) of Measles Antibody

  "at least 30 days to less than 365 days post vaccination"

• Geometric Mean Titer (GMT) of Mumps Antibody

  "at least 30 days to less than 365 days post vaccination"

• Geometric Mean Titer (GMT) of Rubella Antibody

  "at least 30 days to less than 365 days post vaccination"

Study Arms (1)

Open Label

EXPERIMENTAL

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

Interventions

ProQuad BIOLOGICAL

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.

Open Label

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent and/or legal guardian willing and able to give informed consent.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina, Pediatric Nephrology

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Liver Failure, Acute; Heart Diseases

Interventions

measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Cardiovascular Diseases

Study Officials

• Katherine Twombley, MD

  Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 22, 2016
• Study Start: December 1, 2015
• Primary Completion: November 3, 2016
• Study Completion: November 3, 2016
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)