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Pertussis (Tdap) Vaccination in Pregnancy

NCT01698346 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-10-24

No results posted yet for this study

Summary

Despite good vaccination coverage, included in national immunization programs in developed countries, the number of reported pertussis cases is rising, also in very young infants. Current immunization strategies fail to protect infants too young to be immunized with the licensed vaccine. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants. Early humoral immunity will be assessed and the influence on vaccine response of the infant measured. The present study offers the opportunity to have new insights in neonatal immunological mechanisms against pertussis and a better understanding in strategies to protect infants against pertussis.

Conditions

  • Pertussis
  • Pregnancy

Interventions

BIOLOGICAL

Pertussis vaccine

Vaccination during pregnancy with a pertussis containing vaccine

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Elke Leuridan, MD, PhD · Universiteit Antwerpen

  • Thu Ha Thi Hoang, MD PhD · National Institute for Hygiene and Epidemiology

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Belgium
  • Vietnam

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 NCT01698346 on ClinicalTrials.gov