Vaccine Exposure During PregnancyNCT01374009
H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009
An observational study of Vaccine Exposure During Pregnancy, run by Dalhousie University at 7 sites in Canada.
Trial summary
The goal of this study it to rapidly create a brief registry of pregnant women who receive the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1 2009/2010 influenza season. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccine Exposure During Pregnancy
- How many people
- 504 participants
- Where
- 7 sitesCanada
- Study dates
- Apr 2010to Dec 2012
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women who recieved the H1N1 vaccine during pregnancy in 2009.
Who may be able to join
- Received the H1N1 vaccine during pregnancy
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3K 6R8
Queen's University
Kingston, Ontario
Li Ka Shing Knoweldge Institute
Toronto, Ontario
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre and Women's College Hospital
Toronto, Ontario
Children's and Women's Health Centre, University of British Columbia
Vancouver, British Columbia
About this study
The goal of this study it to rapidly create a brief registry of pregnant women who receive the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1 2009/2010 influenza season.
Read the detailed description
For Part 1, a brief amount of data will be collected on each woman at the time of her vaccination. These data will be filled out on a single data collection sheet by her Obstetrics Clinic physician or nurse, which will be completed at the time of her vaccination.
For Part 2, after a woman's expected delivery date, data sources will be used for participants. Two groups of non-vaccinated controls will be derived from the provincial perinatal databases:
- The active non-vaccinated controls will be recruited from the concurrent year, matched to women who were vaccinated in 2009/2010. For each of the three perinatal databases, 5 non-vaccinated active controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
- The passive non-vaccinated controls will be derived from the preceding year (i.e., 2008). For each of the three perinatal databases, 5 non-vaccinated passive controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
For women who delivered in Ontario, the Niday Perinatal Database will be used. (https://www.nidaydatabase.com/info/index.shtml).
For women who deliver in British Columbia, their data will be linked to the British Columbia Perinatal Database Registry (http://www.bcphp.ca/Database%20Content.htm). Women who deliver in Nova Scotia will be linked to Nova Scotia Atlee Perinatal Database (http://rcp.nshealth.ca/rcp_3347.html).
Information that will be obtained is as follows:
- Actual delivery date (DD/MM/YYYY)
- Number of infants delivered
- Mode of delivery (vaginal for Caesarean)
- Liveborn or stillborn
- Presence of a congenital anomaly
- Presence of intrauterine growth restriction or small-for-gestational age birthweight
- Presence of a neonatal infection
- Presence of neonatal sepsis
- Need for ventilation of the neonate
- Need for Neonatal Intensive Care of the Neonate.
For Part 3, between 18-24 months after a woman's actual delivery date, a woman may be telephoned at her home to ask her about the health and developmental milestones of her baby. This phase may or may not be done, but consent will be obtained nonetheless.
- Conditions
- Vaccine Exposure During Pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionDec 2012
Why it stopped: Participants were consented but registry was not developed due to low numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Exposure During PregnancyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Li Ka Shing Foundation, PHAC/CIHR Influenza Research Network
- Responsible party
- Principal investigator, Shelly A. McNeil, Dalhousie University
- Investigators
- Shelly A McNeil, MD FRCPC, Principal investigator, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NSJoel Ray, MD FRCPC, Principal investigator, St. Michael's Hospital/University of Toronto, Toronto, OntarioAlison McGeer, MD MSc FRCPC, Principal investigator, Mount Sinai Hospital/University of Toronto, Toronto, OntarioDeborah Money, MD FRCSC, Principal investigator, University of British Columbia, Vancouver, British ColumbiaGraeme N Smith, MD PhD FRCSC, Principal investigator, Queen's Inversity, Kingston, OntarioJennifer Blake, MD MSc FRCSC, Principal investigator, Sunnybrook Health Sciences Centre and Women's College Hospital, University of TorontoMark Yudin, MD MSc FRCSC, Principal investigator, St. Michael's Hospital, University of Toronto, Toronto, OntarioMuhammad Mamdani, PharmD MPH, Principal investigator, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374009
- Sponsor's protocol ID
- 114141
- Status last verified
- Jan 2017
- First submitted
- 14 Jun 2011
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009
- ClinicalTrials.gov ID
- NCT01374009
- Acronym / sponsor ID
- 114141
- Conditions
- Vaccine Exposure During Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participants were consented but registry was not developed due to low numbers
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Li Ka Shing Foundation, PHAC/CIHR Influenza Research Network
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jun 2011 (estimated)
- 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.
The goal of this study it to rapidly create a brief registry of pregnant women who receive the H1N1 vaccine in Ontario, British Columbia, and Nova Scotia during the pandemic H1N1 2009/2010 influenza season.
Detailed description
For Part 1, a brief amount of data will be collected on each woman at the time of her vaccination. These data will be filled out on a single data collection sheet by her Obstetrics Clinic physician or nurse, which will be completed at the time of her vaccination.
For Part 2, after a woman's expected delivery date, data sources will be used for participants. Two groups of non-vaccinated controls will be derived from the provincial perinatal databases:
- The active non-vaccinated controls will be recruited from the concurrent year, matched to women who were vaccinated in 2009/2010. For each of the three perinatal databases, 5 non-vaccinated active controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
- The passive non-vaccinated controls will be derived from the preceding year (i.e., 2008). For each of the three perinatal databases, 5 non-vaccinated passive controls will be matched by maternal age +/- 3 years, same-hospital delivery, and delivery date +/- 7 days.
For women who delivered in Ontario, the Niday Perinatal Database will be used. (https://www.nidaydatabase.com/info/index.shtml).
For women who deliver in British Columbia, their data will be linked to the British Columbia Perinatal Database Registry (http://www.bcphp.ca/Database%20Content.htm). Women who deliver in Nova Scotia will be linked to Nova Scotia Atlee Perinatal Database (http://rcp.nshealth.ca/rcp_3347.html).
Information that will be obtained is as follows:
- Actual delivery date (DD/MM/YYYY)
- Number of infants delivered
- Mode of delivery (vaginal for Caesarean)
- Liveborn or stillborn
- Presence of a congenital anomaly
- Presence of intrauterine growth restriction or small-for-gestational age birthweight
- Presence of a neonatal infection
- Presence of neonatal sepsis
- Need for ventilation of the neonate
- Need for Neonatal Intensive Care of the Neonate.
For Part 3, between 18-24 months after a woman's actual delivery date, a woman may be telephoned at her home to ask her about the health and developmental milestones of her baby. This phase may or may not be done, but consent will be obtained nonetheless.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who recieved the H1N1 vaccine during pregnancy in 2009.
Key inclusion criteria (1 listed)
- Received the H1N1 vaccine during pregnancy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Participants were consented but registry was not developed due to low numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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.
Shelly A McNeil, MD FRCPC principal investigator
Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS
Joel Ray, MD FRCPC principal investigator
St. Michael's Hospital/University of Toronto, Toronto, Ontario
Alison McGeer, MD MSc FRCPC principal investigator
Mount Sinai Hospital/University of Toronto, Toronto, Ontario
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Exposure During Pregnancy, run by Dalhousie University at 7 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 1 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: stopped early, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
The study was stopped early (reason given: Participants were consented but registry was not developed due to low numbers). Results are not available in the source record.
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.
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 Jan 2017.