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Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

NCT03457194 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2024-01-31

No results posted yet for this study

Summary

This study has been designed to investigate if:

1. BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
2. If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
3. If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.

Conditions

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine

Inactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine). Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care.

BIOLOGICAL

DTP Vaccine (Multiple Actives)

Pertussis vaccine acellular combined with diphtheria and tetanus toxoids. Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Women's and Children's Hospital, Australia

    lead OTHER_GOV

Principal Investigators

  • Helen S Marshall, MBBS,MD,MPH · Vaccinology and Immunology Research Trials Unit (VIRTU)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2023-09-29
Completion
2024-03-01
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT03457194 on ClinicalTrials.gov