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OpenTrials
Completed

NCT Number: NCT00996853

Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom

The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation of safety data.

This study is a commitment to the European Medicines Agency (EMEA), as part of GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza vaccination.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

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About this study

Collaborator: Medicines and Healthcare products Regulatory Agency

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent, and assent where appropriate, obtained from the subject/from the subject's parent(s)/ Legally Acceptable Representative(s) (LAR).
  • A male or female subject vaccinated with a first dose of GSK Biologicals' H1N1 pandemic influenza vaccine
  • shortly (<24h) before being recruited in the study, and
  • within a GP practice participating in the study and where the subject is registered.
  • Subjects who the Investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol

Exclusion criteria

  • Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
  • Child in care

Treatment and study plan

Safety follow up

Other

Collection of reactogenicity data from diary cards, reporting of medically-attended adverse events, reporting of serious adverse events and adverse events of special interest, reporting of pregnancy outcomes and fatalities.

Primary outcomes

  1. Medically-attended adverse events

    Time frame: Within one month after any dose

Secondary outcomes

  1. Adverse events solicited to assess reactogenicity

    Time frame: Within seven days after any dose

  2. Serious adverse events and adverse events of special interest

    Time frame: Within six months after the second vaccine dose or within a maximum of eight months after the first dose

  3. Pregnancy outcomes

    Time frame: Within two months after vaccination (last menstrual period up to 45 days after any dose)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)

Acronym: H1N1 PASS UK

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 16, 2009
Registry last updated
Jan 16, 2018

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.

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