CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 156 enrolled
Drug / intervention
Prevnar®13 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02447718
NCT02447718Phase 4Completed

Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study

Canadian Immunization Research Network·interventional·Posted May 19, 2015·Updated Jun 24, 2022

In Brief

A Phase 4 clinical trial evaluating Prevnar®13, Pneumovax® 23, and 1 other intervention for Acute Lymphoblastic Leukemia. Completed, enrolled 156 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 19, 2015
Enrollment StartNov 16, 2015
Primary CompletionMar 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.1 years ago

Interventions

Prevnar®13biological

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

Pneumovax® 23biological

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

Pediacel®biological

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