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Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women

NCT02783170 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-07-28

Study results available
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Summary

This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the vaccines (IIV followed by Tdap \~ 21 days later). Vaccines will be administered by licensed study personnel.

Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when possible.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on study participant preference.

Maternal serum samples will be collected for antibody titers relevant to the Tdap and Influenza at time points that include: prior to vaccination(s), \~21 days post vaccination(s), and at delivery. Additionally, cord blood serum will be analyzed for the same antibody titers.

Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained from medical record review.

Conditions

  • Pregnancy

Interventions

BIOLOGICAL

Tetanus, Diphtheria, and Pertussis Vaccine

BIOLOGICAL

2016-2017 Quadrivalent Inactivated Influenza Vaccine

BIOLOGICAL

2017-2018 Quadrivalent Inactivated Influenza Vaccine

Sponsors & Collaborators

Principal Investigators

  • Geeta Swamy, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-04-03
Completion
2018-05-10

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02783170 on ClinicalTrials.gov