Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™

GlaxoSmithKline1 site in 1 country162 target enrollmentSeptember 15, 2010

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 162
Locations: 1
Primary Endpoint: Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.

Registry

clinicaltrials.gov

Start Date

September 15, 2010

End Date

May 26, 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
•Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
•Healthy subjects as established by medical history and clinical examination before entering into 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

•Active participation in other clinical trials.
•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.
•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.
•Acute disease and/or fever at the time of enrolment.
•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.
•Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
•Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
•History of seizures or progressive neurological disease.

Outcomes

Primary Outcomes

Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

Time Frame: Day 0 and 28

Antibody titers were expressed as Geometric mean titers (GMTs).

Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

Time Frame: Day 0-28

Seropositivity was defined as antibody titers greater than or equal to 1:10.

Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

Time Frame: Day 0-28

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

Time Frame: Day 28

A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

Time Frame: Day 28

MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.

Secondary Outcomes

HI Antibody Titers Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine(Day 28)
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine(Day 28)
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains(Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only))
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Day 0 and Month 6)
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix(Day 28)
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine(Month 6)
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7 days (Day 0 - 6) after vaccination)
Duration of Any Solicited Local Symptom(During the 7 days (Days 0 - 6) after vaccination)
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7 days (Days 0-6) after vaccination)
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old(During a 7-day follow-up period (Day 0-6) after vaccination)
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms(During a 7-day follow-up period (Day 0-6) after vaccination)
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old(During a 7-day follow-up period (Day 0-6) after vaccination)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During a 28 day follow-up period (Day 0-27) after vaccination)
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest(During the entire study period (up to Month 6))
Number of Subjects Reporting Serious Adverse Events (SAEs)(Up to Month 6)