Last updated: 11/07/2018 06:11:44

Safety, immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (H1N1) (GSK2340272A)

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GSK study ID
113462
See study documents
Clinicaltrials.gov ID
NCT00971321
See results summary
EudraCT ID
2009-013783-39
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: Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 6 to 35 months
Trial description: This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals’ investigational vaccine GSK2340272A in children aged between 6 and 35 months.
This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of seropositive subjects for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 0

Number of seropositive subjects for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 42

Titers for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 0

Titers for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 42

Number of seroconverted subjects in terms of H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 42

Number of seroprotected subjects for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Day 42

Seroconversion factor (SCF) for H1N1 Haemagglutination Inhibition (HI) antibody titers

Timeframe: At Day 42

Secondary outcomes:

Number of seropositive subjects for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Days 0, 21, 42, and at Month 11-12

Titers for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Days 0, 21, 42 and at Month 11-12

Number of seroconverted subjects in terms of H1N1 Haemagglutination Inhibition (HI) antibody titers

Timeframe: At Days 21, 42 and at Month 11-12

Number of seroprotected subjects for H1N1 Haemagglutination Inhibition (HI) antibodies

Timeframe: At Days 0, 21, 42 and at Month 11-12

Seroconversion factor (SCF) for H1N1 Haemagglutination Inhibition (HI) antibody titers

Timeframe: At Days 21, 42 and at Month 11-12

Titers for serum neutralising antibodies

Timeframe: At Days 0, 21 and 42

Titers for serum neutralising antibodies

Timeframe: At Days 0, 21, 42 and at Month 11-12

Number of subjects with vaccine response for serum neutralising antibodies

Timeframe: At Days 21 and 42

Number of subjects with vaccine response for serum neutralising antibodies

Timeframe: At Days 21, 42 and at Month 11-12

Number of subjects with any and Grade 3 solicited local symptoms

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

Number of subjects with any medically-attended events (MAEs)

Timeframe: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)

Number of subjects with any adverse events of specific interest (AESIs)/ potential immune-mediated disease (pIMDs)

Timeframe: During the entire study period (Day 0 up to Month 11-12)

Number of subjects with normal/abnormal biochemical levels

Timeframe: At Days 0, 21 and 42

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

Timeframe: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (Day 0 up to Month 11-12)

Interventions:
Biological/vaccine: Pandemic influenza vaccine GSK2340272A
Enrollment:
157
Observational study model:
Not applicable
Primary completion date:
2010-24-11
Time perspective:
Not applicable
Clinical publications:
Carmona A et al. (2010) Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 28(36):5837-5844.
Garcia-Sicilia J et al. (2015) Safety and persistence of the humoral and cellular immune responses induced by two doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: two open, uncontrolled studies. Hum Vaccin Immunother. 11(10):2359-2369.
Medical condition
Influenza
Product
GSK2340272A
Collaborators
Not applicable
Study date(s)
September 2009 to November 2010
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
6 - 35 months
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
  • 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.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol

    • Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
    • Written informed consent obtained from the parent(s) or LAR(s) of the subject.
    • Healthy children, as established by medical history and clinical examination when entering the study.
    • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion criteria:

    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.

    • Clinically or virologically confirmed influenza infection within six months preceding the study start.
    • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
    • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
    • History of hypersensitivity to vaccines.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment
    • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
    • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
    • Child in Care.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Bilbao, Spain, 48013
Status
Study Complete
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Location
GSK Investigational Site
Burgos, Spain, 09005
Status
Study Complete
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Location
GSK Investigational Site
Madrid, Spain, 28046
Status
Study Complete
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Location
GSK Investigational Site
Sevilla, Spain, 41013
Status
Study Complete
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Location
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
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

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2010-24-11
Actual study completion date
2010-24-11

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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