NCT04082299

Brief Summary

Pregnancy involves changes in immune response. The investigators aim to evaluate the immune response to Tdap in pregnancy in comparison to non pregnant women usig proteomics and gene sequencing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 12, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2023

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

September 5, 2019

Last Update Submit

May 6, 2025

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Outcome Measures

Primary Outcomes (1)

  • Immune response following Tdap vaccine

    Characterization of immune response following Tdap vaccine.

    4 months

Study Arms (2)

Pregnant women

pregnant women expected to be vaccinate with Tdap vaccine during their 3th trimester

Non pregnant women

Non pregnant women expected to be vaccinate with Tdap vaccine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant and non pregnant women

You may qualify if:

  • age between 18-45 years
  • pregnant women who expected to have Tdap vaccine
  • Informed Consent Form signature
  • age between 18-45 years
  • non pregnant women who expected to have Tdap vaccine
  • Informed Consent Form signature

You may not qualify if:

  • any background immune diseases- autoimmune conditions or cancer.
  • women who take immunosuppressive/ immunomodulatory medications
  • a patient has received Tdap vaccine in 6 months prior to study entry.
  • no will to signed the Informed Consent Form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, 3810101, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood for Immunoglobulin G analysis, umbilical blood and mother milk.

Study Officials

  • Rinat Gabbay-Benziv, Dr

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

September 12, 2019

Primary Completion

October 19, 2023

Study Completion

October 19, 2023

Last Updated

May 9, 2025

Record last verified: 2025-05

Locations

IL(1)