Last updated: 11/07/2018 06:22:19

Study to evaluate immunological equivalence between two investigational influenza vaccines in adults (H1N1)

GSK study ID
113535
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunological equivalence between GSK2340272A and GSK2340274A influenza vaccines in adults aged 18 to 60 years
Trial description: The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals’ adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Day 21

Secondary outcomes:

Number of seroconverted (SCR) subjects for HI antibodies

Timeframe: At Days 21 and 42

Number of SCR subjects for HI antibodies

Timeframe: At Days 182 and 364

Titers for serum HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 0 and 42

Titers for serum HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 182 and 364

Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 0, 21 and 42

Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain

Timeframe: At Days 182 and 364

Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 21 and 42

Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 strain of influenza disease

Timeframe: At Days 182 and 364

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of days with solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of days with solicited general symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with potential immune-mediated diseases (pIMDs)

Timeframe: From Day 0 up to Day 42

Number of subjects with pIMDs

Timeframe: During the entire study period (from Day 0 up to Day 364)

Number of subjects with any adverse event of special interest (AESIs)

Timeframe: During the entire study period (from Day 0 up to Day 364)

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 up to Day 364)

Interventions:
Biological/vaccine: Influenza vaccine GSK2340272A
Biological/vaccine: Influenza vaccine GSK2340274A
Enrollment:
336
Observational study model:
Not applicable
Primary completion date:
2009-09-11
Time perspective:
Not applicable
Clinical publications:
Launay O et al. (2013) Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 13(435):1-11.
Medical condition
Influenza
Product
GSK2340272A, GSK2340274A
Collaborators
Not applicable
Study date(s)
October 2009 to November 2010
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
Location
GSK Investigational Site
Poitiers, France, 86000
Status
Study Complete
Location
GSK Investigational Site
Paris Cedex 18, France, 75877
Status
Study Complete
Location
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
Status
Study Complete
Location
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
Status
Study Complete
Location
GSK Investigational Site
Paris, France, 75679
Status
Study Complete
Location
GSK Investigational Site
Caen cedex 9, France, 14033
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2009-09-11
Actual study completion date
2010-04-11

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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