Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months

GlaxoSmithKline1 site in 1 country113 target enrollmentApril 18, 2011

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 113
Locations: 1
Primary Endpoint: Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

Detailed Description

This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.

Registry

clinicaltrials.gov

Start Date

April 18, 2011

End Date

November 2, 2012

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
•Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy children as established by medical history and clinical examination before entering the study.
•Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
•Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Exclusion Criteria

•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of any neurological disorders or seizures.
•Acute disease at the time of enrolment.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
•Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
•Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.

Outcomes

Primary Outcomes

Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain

Time Frame: At Day 192

Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).

Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain

Time Frame: At Day 192

A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.

Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain

Time Frame: At Day 192

A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.

Secondary Outcomes

Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain(At Day 0, Day 42, Day 182, Day 192 and Day 364)
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 0, Day 182, Day 192 and Day 364)
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain(Day 182 and Day 364)
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182, Day 192 and Day 364)
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain(At Day 0, Day 182, Day 192 and Day 364)
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain(At Day 0, Day 42, Day 182, Day 192 and Day 364)
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005(At Day 0, Day 42, Day 182, Day 192 and Day 364)
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 182 and Day 364)
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182 and Day 364)
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182, Day 192 and Day 364)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189))
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(Day 0, Day 42, Day 182, Day 192 and Day 364)
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(Day 0, Day 42, Day 182, Day 192 and Day 364)
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 182, Day 192 and Day 364)
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to 364))
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189))
Number of Subjects With Potential Immune-mediated Disease (pIMDs)(During the entire study period (from day 0 to Day 364))
Number of Subjects With Medically-attended Events (MAEs)(During the entire study period (from Day 0 to Day 364))
Number of Subjects With Unsolicited Adverse Events (AEs)(During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266))