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

NCT ID: NCT01374009

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 504 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Vaccine Exposure During Pregnancy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Received the H1N1 vaccine during pregnancy

Exclusion Criteria

• None

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Li Ka Shing Foundation

OTHER

Sponsor Role: collaborator

PHAC/CIHR Influenza Research Network

OTHER_GOV

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: lead

Responsible Party

Shelly A. McNeil

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shelly A McNeil, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS

Joel Ray, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital/University of Toronto, Toronto, Ontario

Alison McGeer, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital/University of Toronto, Toronto, Ontario

Deborah Money, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Vancouver, British Columbia

Graeme N Smith, MD PhD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's Inversity, Kingston, Ontario

Jennifer Blake, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre and Women's College Hospital, University of Toronto

Mark Yudin, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto, Toronto, Ontario

Muhammad Mamdani, PharmD MPH

Role: PRINCIPAL_INVESTIGATOR

Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario

Locations

Children's and Women's Health Centre, University of British Columbia

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Queen's University

Kingston, Ontario, Canada

Li Ka Shing Knoweldge Institute

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre and Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

114141

Identifier Type: -

Identifier Source: org_study_id