Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)

NCT01527591 | Active Not Recruiting

• 1 other identifier: Pfizer-Prevnar13®
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and long-term immunogenicity of the 13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant recipients.

Conditions

Infection in Solid Organ Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• To measure antibody concentrations by EIA and opsonophagocytosis assay (OPA)

  Immunogenicity, functional antibody responses and sero-conversion will be evaluated by enzyme immunoassay (EIA) and opsonophagocytosis assay to a booster immunization with PCV13 vaccine in SOT-recipient children 12-59 months of age

  Measured at different time points until 240 weeks post PCV 13 booster dose

Secondary Outcomes (1)

• To measure the extent and persistence of immunity by measuring antibody concentrations by EIA and OPA

  Measured at different time points until 240 weeks post PCV 13 booster dose

Study Arms (1)

vaccine

OTHER

pneumococcal conjugated vaccine

Biological: Pneumococcal Conjugate Vaccine 13 (PCV13)

Interventions

Pneumococcal Conjugate Vaccine 13 (PCV13) BIOLOGICAL

A single intramuscular dose of 0.5 mL.

Also known as: Prevnar13®

vaccine

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Are 12 to 59 months of age.
• Have received a solid organ transplantation requiring ongoing immunosuppression.
• Have been receiving immunosuppressive agents for at least 3 months. Non-steroidal anti-inflammatory agents, G-CSF, erythropoietin and inhaled corticosteroids are not considered immunosuppressive agents for the purposes of this study.
• Expect to be able to complete the study injection and follow-up.
• Have parent or guardian's consent.
• Have received at least 3 doses of an approved PCV7 and/or PCV13 vaccine series.

You may not qualify if:

• Have received any inactivated vaccine within 4 weeks, or any live vaccine within 6 weeks of entering the study.
• Have had an allergic reaction or a serious side effect after receipt of any previous immunization to pneumococcal vaccines, or to other routine childhood immunizations.
• Have any other condition that would make receiving study vaccine inadvisable.
• Have other diseases of the immune system.
• Have any other disease or previous surgery that would interfere with study treatment.
• Are likely to have bleeding disorders.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095-1752, United States

Location

Study Officials

• Jaime G Deville, MD, FAAP

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Infectious Diseases

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: February 7, 2012
• Study Start: February 1, 2012
• Primary Completion: December 31, 2023
• Study Completion: December 30, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-01

Locations

US (1)