Pertussis Maternal Immunization Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pertussis Vaccine in Healthy Pregnant Women

NCT00707148

Diphtheria Pertussis Tetanus

COMPLETED PHASE1

Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

NCT03498300

Pertussis Pregnancy Related

COMPLETED EARLY_PHASE1

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

NCT07097012

RSV Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination Pregnancy +1 more

RECRUITING PHASE4

TDAP Safety in Pregnant Women

NCT02209623

Pertussis

COMPLETED

Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States

NCT05040802

Pertussis (Whooping Cough)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to assess the potential of providing initial immunological protection to the neonate by providing passive placentally transferred serum antibodies and breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be accomplished by

* determining the rate of maternal antibody decline from time of immunization until 12 months postpartum by measuring antibody levels in serum, saliva, and breast milk at specified intervals;
* determining levels of antibody transferred to the neonate relative to the interval from immunization to delivery;
* comparing levels of transplacentally transferred antibody with those achieved after the first, second, and third dose of the primary immunization series; and
* determining whether maternal immunization interferes with active antibody production following licensed DTaP-IPV-Hib in infants of women immunized during the mid third trimester of pregnancy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group I

Tdap

Group Type EXPERIMENTAL

Tdap

Intervention Type BIOLOGICAL

0.5 mL IM once at visit #2

group 2

Td

Group Type ACTIVE_COMPARATOR

Td

Intervention Type BIOLOGICAL

0.5 mL IM once at visit #2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tdap

0.5 mL IM once at visit #2

Intervention Type BIOLOGICAL

Td

0.5 mL IM once at visit #2

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Adacel Diphtheria and tetanus toxoids, adsorbed

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women 18 years of age and over.
* Women who, at ≥30-\<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
* Signed, informed consent.

Exclusion Criteria

* Failure to meet eligibility criteria as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
* History of significant medical disorder (such as bleeding disorders, cancer, autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant recipients), seizure disorder or significant psychiatric illness, drug or alcohol dependence).
* Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone daily or equivalent.
* History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
* Personal history (verbal or documented) of ever having received Tdap.
* Personal history (verbal or documented) of having received Td immunization within the past 2 years.
* History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
* History of sensitivity to any component of Tdap.
* Receipt of blood products or immunoglobulin within 3 months of study entry (except RH-negative women who receive immunoglobulin during pregnancy are eligible).
* Receipt of any vaccines within 2 weeks of study vaccine (except influenza vaccine which may be given concurrently).
* Failure to give written, informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes