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CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study

NCT03384589 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-03-04

No results posted yet for this study

Summary

This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This study aims to find out if it is possible to achieve the same protection using just 2 doses, at 2 and 12 months.

Conditions

  • Invasive Pneumococcal Disease, Protection Against
  • Streptococcus Pneumoniae Infection

Interventions

BIOLOGICAL

PCV13

Vaccine against pneumococcal disease

Sponsors & Collaborators

  • Canadian Immunization Research Network

    collaborator NETWORK

  • Alberta Children's Hospital

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • IWK Health Centre

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Manish Sadarangani, MD · UBC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

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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 NCT03384589 on ClinicalTrials.gov