Last updated: 11/04/2018 07:35:13

Integrated summary of the safety of AS03-adjuvanted monovalent H5N1 and H1N1 vaccines in adults 18 years of age and older

GSK study ID
Flu-Pan-Meta-Analysis-201109
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Integrated summary of the safety of AS03-adjuvanted monovalent H5N1 and H1N1 vaccines in adults 18 years of age and older
Trial description: The aim of the current Integrated summary of safety (ISS) was to pool the safety data of 28 clinical trials of GSK’s AS03-adjuvanted Quebec-manufactured (Q-Pan) and Dresden-manufactured (D-Pan) pandemic H5N1 and H1N1 vaccines administered to adults subjects. This ISS intended to extend the data on less common and medically more serious events, through the evaluation of all available data from adult recipients of GSK’s adjuvanted D-PAN and Q-PAN H5N1 and H1N1 vaccines.
The specific objectives of the different analyses presented in this ISS were:
• To develop an estimate of the incidence of medically-attended adverse events (MAEs) and serious adverse events (SAEs) after the primary vaccination series based on the maximum sample size attainable in subjects with comparable data.
• To increase the likelihood of detecting rare adverse events, and more specifically potential immune-mediated diseases (pIMDs), in order to generate hypotheses as to whether these could represent adjuvanted (pre-) pandemic influenza vaccine-attributable safety findings that merit further examination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of any adverse events of special interest (AESIs) according to the MedDRA preferred Terms classification or by Standardized MedDRA Query (SMQ)

Timeframe: From Day 0 upto 16 March 2011 Data lock point (DLP)]

Occurrence of any Serious Adverse Events (SAEs) according to the MedDRA preferred Terms classification

Timeframe: From Day 0 upto 16 March 2011 Data lock point (DLP)]

Occurrence of any potential immune-mediated diseases (pIMDs) according to the MedDRA preferred Terms classification

Timeframe: From Day 0 upto 16 March 2011 Data lock point (DLP)]

Occurrence and intensity of any medically attended adverse events (MAEs) according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred Terms classification

Timeframe: From Day 0 upto 16 March 2011 Data lock point (DLP)]

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    19686
    Primary completion date:
    2011-01-09
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Pandemic Influenza
    Product
    H1N1 Pandemic Influenza Vaccine, H5N1 Pandemic Influenza Vaccine
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to September 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    yes
    • All completed and ongoing clinical trials (at the time of DLP, 16 March 2011) in adults using AS03-adjuvanted vaccines manufactured at GSK facilities in Dresden, Germany or Quebec, Canada.
    • Subjects 18 years of age and older who received the AS03-adjuvanted pandemic vaccines (alone or followed with the administration of another study vaccine) and unadjuvanted mono- or trivalent influenza control vaccine or placebo in eligible studies were included.
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All completed and ongoing clinical trials (at the time of DLP, 16 March 2011) in adults using AS03-adjuvanted vaccines manufactured at GSK facilities in Dresden, Germany or Quebec, Canada.
    • Subjects 18 years of age and older who received the AS03-adjuvanted pandemic vaccines (alone or followed with the administration of another study vaccine) and unadjuvanted mono- or trivalent influenza control vaccine or placebo in eligible studies were included.
    Exclusion criteria:
    • Not Applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2011-01-09
    Actual study completion date
    2011-01-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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