Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

GlaxoSmithKline1 site in 1 country2,116 target enrollmentOctober 13, 2009

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 2116
Locations: 1
Primary Endpoint: Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Registry

clinicaltrials.gov

Start Date

October 13, 2009

End Date

June 17, 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
•A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
•Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
•has practiced adequate contraception for 30 days prior to vaccination, and
•has a negative pregnancy test on the day of vaccination, and
•has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

•Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
•Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
•Child in care
•Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•History of hypersensitivity to any vaccine.
•History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Outcomes

Primary Outcomes

Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.

Time Frame: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).

Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.

Time Frame: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees 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 four-fold increase in post-vaccination titer.

Secondary Outcomes

Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.(During a 4-day follow-up period (Days 0-3) after vaccination.)
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.(At Day 0 and 28 after last vaccine dose.)
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and 28 after last vaccine dose.)
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 28 after last vaccine dose.)
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and 28 after last vaccine dose.)
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.(At Day 0 and at Day 28 after last vaccine dose)
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.(During a 28 day follow-up period (Days 0-27) after vaccination.)
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).(During the entire study period (From Day 0 up to Day 180).)
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.(At Day 0 and at Day 28 after last vaccine dose)
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).(During a 4-day follow-up period (Days 0-3) after vaccination.)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).(During a 28 day follow-up period (Days 0-27) after vaccination.)
Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period (From Day 0 up to Day 180).)