NCT03909126

Brief Summary

Brief Summary: The study compares four models of pertussis vaccination dispensation to pregnant women on the vaccine coverage obtained. In addition, the cost of the different models of vaccination will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
946

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

3 active sites

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

October 24, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

October 24, 2018

Last Update Submit

September 22, 2021

Conditions

Pertussis

Keywords

pertussisimmunization coveragevaccinationpregnant womenQuebec

Outcome Measures

Primary Outcomes (4)

  • Proportion of pregnant women vaccinated against pertussis

    Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions

    11 months, May 2019 o March 2020

  • Proportion of pregnant women who consider pertussis as serious risk for infant

    Understanding of pertussis risk

    12 months, May 2019 to April 2020

  • Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.

    Understanding of vaccine risk perception in pregnant women

    12 months, May 2019 to April 2020

  • Costs for each vaccinated woman

    The cost of vaccination will be evaluated and compared between the four vaccination models.

    12 months, January to December 2019

Study Arms (4)

Montreal Region of Quebec

EXPERIMENTAL

Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting

Biological: Boostrix administered during gestational diabetes screening

Montérégie

NO INTERVENTION

Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic

Maurice Region

EXPERIMENTAL

Vaccination with Boostrix of pregnant women receiving routine care at high volume clinic

Biological: Boostrix administered in high volume obstetric clinic

National Capital

NO INTERVENTION

Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic

Interventions

Boostrix administered during gestational diabetes screeningBIOLOGICAL

Boostrix administered during gestational diabetes screening

Montreal Region of Quebec
Boostrix administered in high volume obstetric clinicBIOLOGICAL

Boostrix administered in high volume obstetric clinic

Maurice Region

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women at least 18 years old who speak English or French
  • Signed Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CLSC Montérégie

Longueuil, Quebec, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CLSC Capitale Nationale

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Caroline Quach, MD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Lead Infection Prevention and Control

Study Record Dates

First Submitted

October 24, 2018

First Posted

April 9, 2019

Study Start

June 1, 2019

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)