Clinical trial NCT01190215: Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Official title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Pandemrix
H1N1
Fluarix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 77
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
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' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.


Eligibility criteria: Inclusion Criteria:

* Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
* Subjects having received Pandemrix at least six months prior to study enrolment.
* Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects or Parent(s)/LAR(s) 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:
* 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 confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* 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.
* If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
* Child in care.

Primary outcomes:
measure: Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
timeFrame: At Day 0 and Day 28
measure: Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
timeFrame: At Day 0 and Day 28
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
timeFrame: At Day 28
measure: Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
timeFrame: At Day 0 and Day 28
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
timeFrame: At Day 28
Secondary outcomes:
measure: Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and Day 28
measure: Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and at Month 6
measure: Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and Day 28
measure: Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and at Month 6
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 28
measure: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Month 6
measure: Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and Day 28
measure: Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and Month 6
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 28
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Month 6
measure: Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and at Day 28
measure: Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 0 and at Month 6
measure: Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Day 28
measure: Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
timeFrame: At Month 6
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Days With Any Solicited Local Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Days With Grade 3 Solicited Local Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Days With Any Solicited General Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Days With Grade 3 Solicited General Symptoms.
timeFrame: Within 7 days (Day 0 - Day 6) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: Within 28 days (Day 0 - Day 27) after vaccination
measure: Number of Subjects Reporting Medically-attended Events (MAEs).
timeFrame: Within the 28-day (Days 0-27) post-vaccination period
measure: Number of Subjects Reporting Medically-attended Events (MAEs).
timeFrame: During the entire study period (Up to Month 6)
measure: Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
timeFrame: During the entire study period (Up to Month 6)
measure: Number of Subjects Reporting Adverse Events of Special Interest.
timeFrame: During the entire study period (Up to Month 6)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: Within the 28-day (Days 0-27) post-vaccination period
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Up to Month 6)
Other outcomes:
Locations:
city: Tampere
country: Finland
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.