NCT01374009

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

June 14, 2011

Last Update Submit

January 17, 2017

Conditions

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Received the H1N1 vaccine during pregnancy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Queen's University

Kingston, Ontario, Canada

Location

Li Ka Shing Knoweldge Institute

Toronto, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre and Women's College Hospital

Toronto, Ontario, Canada

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 15, 2011

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

December 1, 2012

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations