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Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand

NCT02408926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2019-10-24

No results posted yet for this study

Summary

Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies.

However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.

Conditions

  • Pertussis

Interventions

BIOLOGICAL

OPV

Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

BIOLOGICAL

Boostrix

Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.

BIOLOGICAL

Infanrix hexa

Children from group A will be vaccinated with an acellular pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

BIOLOGICAL

Quinvaxem

Children from group B will be vaccinated with a whole cell pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Institut Pasteur de Lille

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Elke Leuridan, MD PhD · Universiteit Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Thailand

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 NCT02408926 on ClinicalTrials.gov