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Vaccinating Children After Chemotherapy

NCT02447718 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-06-24

Study results available
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Summary

This multi-center open label clinical trial aims to identify predictors of low antibody titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6 months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and 13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2 months later. The results will support the development of clinical practice guidelines for this population.

Conditions

Interventions

BIOLOGICAL

Prevnar®13

A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.

BIOLOGICAL

Pneumovax® 23

A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13

BIOLOGICAL

Pediacel®

A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.

Sponsors & Collaborators

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Karina Top, MD, MS · Dalhousie University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-16
Primary Completion
2018-03-05
Completion
2018-03-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02447718 on ClinicalTrials.gov