PertussisPhase 4NCT03909126
Pertussis Vaccination in Pregnant Women
A Phase 4 study testing Boostrix administered during gestational diabetes screening and Boostrix administered in high volume obstetric clinic in people with Pertussis, run by St. Justine's Hospital at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Boostrix administered during gestational diabetes screening and Boostrix administered in high volume obstetric clinic
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 946 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jun 2019to 30 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at least 18 years old who speak English or French
- Signed Informed Consent
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
CLSC Montérégie
Longueuil, Quebec
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
CLSC Capitale Nationale
Québec, Quebec
About this study
Official title: Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
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.
Read the detailed description
This is a quasi-experimental study with a non-equivalent control group in pregnant women, taking place in 4 regions of Québec (Montréal, Montérégie, Capitale-Nationale, Mauricie). Four models of vaccine dispensation will be evaluated: one university hospital around gestational diabetes screening, local health and social services centres (CSLC) and a high volume clinic. 250 participants will be recruited in each of the four types of centres.
In addition, the study will also evaluate the costs incurred by all those involved in the pertussis vaccination program for pregnant women as well as the cost per woman vaccinated.
Health Professionals:
15 to 20 health professionals involved in providing immunization services to pregnant women: obsterician-gynaecologists, family doctors and nurses in participating clinics will be interviewed to evaluate their knowledge, attitudes and professional practises regarding pertussis vaccination during pregnancy.
Evaluating the Cost:
A detailed costing approach (micro-costing) will be used. Time and movement will be studied by direct observation using a grid on an electronic file in each of the 5 environments studied in order to identify the services and activities carried out as well as to determine the resources involved in the implementation of these services and activities. Three typical vaccination days will be chosen to make these observations, in each of the four study environments.
The main activities observed will be related to preparations for vaccination up to the vaccination itself (informed consent, injection, etc.), the capture of vaccination data the management of vaccines and equipment, clinical manifestations, etc. If necessary, the people observed can be interviewed directly to better understand the activities or services provided. Otherwise, some questions may be included in the interviews described above.
The major cost categories that will be evaluated for each of the delivery modalities are human resources and supplies. The cost components listed are: nursing time (immunization / training), coordination time, support staff time, office supplies, vaccine storage equipment, vaccine transportation equipment, vaccine transportation, health and safety equipment, emergency, single-use vaccination equipment and others.
With regard to the costs borne by women, the main categories of variables evaluated will be: the time spent making appointments and attending vaccination appointments, working time lost, if any, transportation, childcare and other expenses
- Conditions
- Pertussis
- Being tested
- Boostrix administered during gestational diabetes screening, Boostrix administered in high volume obstetric clinic
- Keywords
- pertussis, immunization coverage, vaccination, pregnant women, Quebec
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix administered during gestational diabetes screeningBiological
Boostrix administered during gestational diabetes screening
Boostrix administered in high volume obstetric clinicBiological
Boostrix administered in high volume obstetric clinic
| Study group | Role | What they receive |
|---|---|---|
| Montreal Region of Quebec | Experimental | Vaccination with Boostrix at time of gestational diabetes screening in a hospital setting Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnant women vaccinated against pertussis
Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Measured: 11 months, May 2019 o March 2020
Proportion of pregnant women who consider pertussis as serious risk for infant
Understanding of pertussis risk
Measured: 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
Measured: 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.
Measured: 12 months, January to December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jun 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Responsible party
- Principal investigator, Caroline Quach, MD, St. Justine's Hospital
- Investigators
- Caroline Quach, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909126
- Sponsor's protocol ID
- MSSS-PERT-001
- Status last verified
- Sep 2021
- First submitted
- 24 Oct 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertussis Vaccination in Pregnant Women: Implementation and Evaluation of Different Models of Vaccination Dispensation
- ClinicalTrials.gov ID
- NCT03909126
- Acronym / sponsor ID
- MSSS-PERT-001
- Conditions
- Pertussis
- Keywords
- pertussis, immunization coverage, vaccination, pregnant women, Quebec
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a quasi-experimental study with a non-equivalent control group in pregnant women, taking place in 4 regions of Québec (Montréal, Montérégie, Capitale-Nationale, Mauricie). Four models of vaccine dispensation will be evaluated: one university hospital around gestational diabetes screening, local health and social services centres (CSLC) and a high volume clinic. 250 participants will be recruited in each of the four types of centres.
In addition, the study will also evaluate the costs incurred by all those involved in the pertussis vaccination program for pregnant women as well as the cost per woman vaccinated.
Health Professionals:
15 to 20 health professionals involved in providing immunization services to pregnant women: obsterician-gynaecologists, family doctors and nurses in participating clinics will be interviewed to evaluate their knowledge, attitudes and professional practises regarding pertussis vaccination during pregnancy.
Evaluating the Cost:
A detailed costing approach (micro-costing) will be used. Time and movement will be studied by direct observation using a grid on an electronic file in each of the 5 environments studied in order to identify the services and activities carried out as well as to determine the resources involved in the implementation of these services and activities. Three typical vaccination days will be chosen to make these observations, in each of the four study environments.
The main activities observed will be related to preparations for vaccination up to the vaccination itself (informed consent, injection, etc.), the capture of vaccination data the management of vaccines and equipment, clinical manifestations, etc. If necessary, the people observed can be interviewed directly to better understand the activities or services provided. Otherwise, some questions may be included in the interviews described above.
The major cost categories that will be evaluated for each of the delivery modalities are human resources and supplies. The cost components listed are: nursing time (immunization / training), coordination time, support staff time, office supplies, vaccine storage equipment, vaccine transportation equipment, vaccine transportation, health and safety equipment, emergency, single-use vaccination equipment and others.
With regard to the costs borne by women, the main categories of variables evaluated will be: the time spent making appointments and attending vaccination appointments, working time lost, if any, transportation, childcare and other expenses
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Montreal Region of Quebec | Experimental | Biological: Boostrix administered during gestational diabetes screeningVaccination with Boostrix at time of gestational diabetes screening in a hospital setting |
| Montérégie | No intervention | –Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic |
| Maurice Region | Experimental | Biological: Boostrix administered in high volume obstetric clinicVaccination with Boostrix of pregnant women receiving routine care at high volume clinic |
| National Capital | No intervention | –Vaccination with Boostrix of pregnant women receiving routine care at the CLSC or regular clinic |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women at least 18 years old who speak English or French
- Signed Informed Consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix administered during gestational diabetes screeningBoostrix administered during gestational diabetes screening | Biological | Montreal Region of Quebec |
| Boostrix administered in high volume obstetric clinicBoostrix administered in high volume obstetric clinic | Biological | Maurice Region |
Primary outcome
Proportion of pregnant women vaccinated against pertussis
Time frame: 11 months, May 2019 o March 2020
Proportion of pregnant women vaccinated against pertussis will be evaluated in 5 Quebec regions
Proportion of pregnant women who consider pertussis as serious risk for infant
Time frame: 12 months, May 2019 to April 2020
Understanding of pertussis risk
Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe.
Time frame: 12 months, May 2019 to April 2020
Understanding of vaccine risk perception in pregnant women
Costs for each vaccinated woman
Time frame: 12 months, January to December 2019
The cost of vaccination will be evaluated and compared between the four vaccination models.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Quach, MD principal investigator
St. Justine's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix administered during gestational diabetes screening and Boostrix administered in high volume obstetric clinic in people with Pertussis, run by St. Justine's Hospital at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pregnant women vaccinated against pertussis (time frame: 11 months, May 2019 o March 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.