Skip to main content
OpenTrials
Completed

NCT Number: NCT01000831

Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

  • To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
  • To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent provided for the subject by a parent or legal guardian
  • Children age 6-35 months

Exclusion criteria

  • Allergies to eggs, thimerosal, gentamicin sulphate or latex
  • Life-threatening reaction to previous Flu vaccine
  • Bleeding disorder
  • Pregnancy
  • Receipt of blood or blood products in past 3 months
  • Chronic illness that could interfere with trial participation
  • Compromised immune system
  • Previous lab-confirmed H1N12009 infection
  • Receipt of H1N12009 vaccine
  • Receipt of Seasonal Influenza vaccine since March 2009

Treatment and study plan

adjuvanted Arepanrix

Biological

Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Other names: Influenza vaccine

Primary outcomes

  1. Safety and immunogenicity of one and two doses Arepanrix

    Time frame: Day 7 and Day 21 post vaccination measured at day 42

    To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age

  2. Rapid Trial

    Time frame: Day 42

    To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • PHAC/CIHR Influenza Research Network

Registry information

Official study title

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2009
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.