Clinical trial NCT01196026: Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
Official title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarix™ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrix™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
H1N1
Fluarix
Pandemrix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 162
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
* Child in care.

Primary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 0 and 28
measure: Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 0-28
measure: Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 0-28
measure: Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 28
measure: Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 28
Secondary outcomes:
measure: HI Antibody Titers Against All Fluarix Vaccine Strains
timeFrame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
measure: HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Day 0 and Month 6
measure: Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
timeFrame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
measure: Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Day 0 and Month 6
measure: Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 28
measure: Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Month 6
measure: Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
timeFrame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
measure: Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Day 0 and Month 6
measure: Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
timeFrame: Day 28
measure: Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Month 6
measure: Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
timeFrame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
measure: Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Day 0 and Month 6
measure: Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
timeFrame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
measure: Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Day 0 and Month 6
measure: Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
timeFrame: Day 28
measure: Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
timeFrame: Month 6
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7 days (Day 0 - 6) after vaccination
measure: Duration of Any Solicited Local Symptom
timeFrame: During the 7 days (Days 0 - 6) after vaccination
measure: Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7 days (Days 0-6) after vaccination
measure: Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During a 28 day follow-up period (Day 0-27) after vaccination
measure: 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
timeFrame: During the entire study period (up to Month 6)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Up to Day 28
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Skellefteå
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.