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Pertussis Maternal Immunization Study

NCT00553228 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2020-08-27

No results posted yet for this study

Summary

The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease

Conditions

  • Pregnant Women

Interventions

BIOLOGICAL

Tdap

0.5 mL IM once at visit #2

BIOLOGICAL

Td

0.5 mL IM once at visit #2

Sponsors & Collaborators

  • IWK Health Centre

    collaborator OTHER

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Scott Halperin

    lead OTHER

Principal Investigators

  • Scott A Halperin, MD · Dalhousie Univeristy - Canadian Center for Vaccinology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2015-12-09
Completion
2015-12-09

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 NCT00553228 on ClinicalTrials.gov