PertussisNCT02096276
Boostrix® Pregnancy Registry
An observational study of Pertussis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. Read more about this study
- Who is it for?
- Ages 12 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 1,517 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2014to 2 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 64 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Eligible pregnancies reported by patients and HCPs
Who may be able to join
- A subject will be included in the Registry if all of the following criteria are met:
- Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
- Subject is a US resident.
- A HCP is identified (name, address and phone number).
- Subject can be identified (by GSK or HCP).
- Data from registered subjects will be included in the analyses if the following criterion is met:
- Pregnancy is ongoing and the outcome is unknown.
Who cannot join
- Data from registered subjects will not be included in the analyses if the following criterion is met:
- Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Research Triangle Park, North Carolina, 27709-3398
About this study
Official title: Boostrix Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix® During Pregnancy or Within 28 Days Preceding Conception
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively
Read the detailed description
The Registry was originally initiated on 03 May 2005, as part of a program of enhanced pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (PASS). The ongoing Registry will therefore be converted into a PASS study in Q1 2014.
Exposed pregnancies reported to the Registry before the transition into a PASS (between 03 May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses.
Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.
Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births for whom the contact details of their HCP will be available) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.
- Conditions
- Pertussis
- Being tested
- Data collection
- Keywords
- Pregnancy Registry, Boostrix, Women, Cohort, Prospective, Pregnancy outcome, Exploratory
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Initial and follow-up data will be collected using questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Group_Prospective | Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and prospective (i.e., registration to registry is done before the outcome of the pregnancy is known) Receives: Other: Data collection | |
| Exposure Group_Retrospective | Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and retrospective (i.e., pregnancy outcome is already known at the time of registration to Registry) Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception.
Pregnancy outcomes included live births, spontaneous abortions (pregnancy loss <22 weeks of gestation), stillbirths (pregnancy loss ≥22 weeks of gestation) and elective terminations.
Each pregnancy outcome was further classified according to the presence or absence of a birth defect.
Measured: Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start31 Mar 2014
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096276
- Sponsor's protocol ID
- 201327
- Status last verified
- Nov 2020
- First submitted
- 21 Mar 2014
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boostrix Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix® During Pregnancy or Within 28 Days Preceding Conception
- ClinicalTrials.gov ID
- NCT02096276
- Acronym / sponsor ID
- 201327
- Conditions
- Pertussis
- Keywords
- Pregnancy Registry, Boostrix, Women, Cohort, Prospective, Pregnancy outcome, Exploratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,517 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively
Detailed description
The Registry was originally initiated on 03 May 2005, as part of a program of enhanced pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (PASS). The ongoing Registry will therefore be converted into a PASS study in Q1 2014.
Exposed pregnancies reported to the Registry before the transition into a PASS (between 03 May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses.
Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.
Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births for whom the contact details of their HCP will be available) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group_Prospective | – | Other: Data collectionPregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and prospective (i.e., registration to registry is done before the outcome of the pregnancy is known) |
| Exposure Group_Retrospective | – | Other: Data collectionPregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and retrospective (i.e., pregnancy outcome is already known at the time of registration to Registry) |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Eligible pregnancies reported by patients and HCPs
Key inclusion criteria (7 listed)
- Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
- Subject is a US resident.
- A HCP is identified (name, address and phone number).
- Subject can be identified (by GSK or HCP).
- Data from registered subjects will be included in the analyses if the following criterion is met:
Key exclusion criteria (2 listed)
- Data from registered subjects will not be included in the analyses if the following criterion is met:
- Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Typically, pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
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 |
|---|---|---|
| Data collectionInitial and follow-up data will be collected using questionnaires. | Other | Exposure Group_Prospective, Exposure Group_Retrospective |
Primary outcome
Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception.
Time frame: Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)
Pregnancy outcomes included live births, spontaneous abortions (pregnancy loss <22 weeks of gestation), stillbirths (pregnancy loss ≥22 weeks of gestation) and elective terminations. Each pregnancy outcome was further classified according to the presence or absence of a birth defect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by GlaxoSmithKline at 1 site in United States.
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 7 inclusion and 2 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception. (time frame: Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)). 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 19 Dec 2020.