H1N1 Vaccine in Pregnancy: a Registry for the Fall and Winter of 2009

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.

Study Overview

• Status: Terminated
• Conditions: Vaccine Exposure During Pregnancy

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:

1. 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.
2. 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 Type: Observational
• Enrollment (Actual): 504

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Children's and Women's Health Centre, University of British Columbia
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Kingston, Ontario, Canada
      • Queen's University
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Li Ka Shing Knoweldge Institute
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre and Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who recieved the H1N1 vaccine during pregnancy in 2009.

Description

Inclusion Criteria:

• Received the H1N1 vaccine during pregnancy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Collaborators and Investigators

• Sponsor: Dalhousie University
• Collaborators: Li Ka Shing Foundation; PHAC/CIHR Influenza Research Network
• Investigators: Principal Investigator: Shelly A McNeil, MD FRCPC, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS; Principal Investigator: Joel Ray, MD FRCPC, St. Michael's Hospital/University of Toronto, Toronto, Ontario; Principal Investigator: Alison McGeer, MD MSc FRCPC, Mount Sinai Hospital/University of Toronto, Toronto, Ontario; Principal Investigator: Deborah Money, MD FRCSC, University of British Columbia, Vancouver, British Columbia; Principal Investigator: Graeme N Smith, MD PhD FRCSC, Queen's Inversity, Kingston, Ontario; Principal Investigator: Jennifer Blake, MD MSc FRCSC, Sunnybrook Health Sciences Centre and Women's College Hospital, University of Toronto; Principal Investigator: Mark Yudin, MD MSc FRCSC, St. Michael's Hospital, University of Toronto, Toronto, Ontario; Principal Investigator: Muhammad Mamdani, PharmD MPH, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 114141