Clinical trial NCT01035749: Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: pandemic influenza
Clinical trial
H1N1
children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 310
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.


Eligibility criteria: Inclusion Criteria:

* Male or female children 10 to \< 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
* Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
* Good general health as established by medical history and clinical examination before entering into 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 the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.

Exclusion Criteria:

* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
* Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
* Presence of a temperature \>= 38.0ºC by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
* Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
* Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
* Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Child in care.

Primary outcomes:
measure: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 21
measure: Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 0 and Day 21
measure: HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 21
Secondary outcomes:
measure: HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 0 and Day 42
measure: HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 0 and Day 182
measure: HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Days 0, 182 and 189
measure: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 42
measure: HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 0 and Day 21
measure: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 182
measure: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 189
measure: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
timeFrame: At Day 189
measure: The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
timeFrame: At Day 0 and Day 42
measure: Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
timeFrame: At Day 0 and Day 182
measure: Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
timeFrame: At Day 0, Day 182 and Day 189
measure: Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1
timeFrame: At Day 42
measure: GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1
timeFrame: At Day 182
measure: GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity
timeFrame: At Day 189
measure: GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity
timeFrame: At Day 189
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
timeFrame: During the 7-day (Days 0-6) post-vaccination period following booster dose
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: During the 7-day (Days 0-6) post-vaccination period following booster dose
measure: Number of Subjects Reporting Any Medically Attended Events (MAEs)
timeFrame: During the entire study period (Days 0-364) following the first vaccination
measure: Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
timeFrame: During the entire study period (Days 0-364) following first vaccination
measure: Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
timeFrame: At Days 0, 21, 42, 182 and 189
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: During the 42-day (Days 0-41) follow up period after first vaccination.
measure: Number of Subjects Reporting Any Unsolicited AEs
timeFrame: During the 21-day (Days 0-20) follow-up period after booster vaccination.
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 to Day 364)
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Cifer
country: Slovakia
facility: GSK Investigational Site
city: Dolny Kubin
country: Slovakia
facility: GSK Investigational Site
city: Dunajska Streda
country: Slovakia
facility: GSK Investigational Site
city: Nova Dubnica
country: Slovakia
facility: GSK Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: GSK Investigational Site
city: Puchov
country: Slovakia
facility: GSK Investigational Site
city: Ruzomberok
country: Slovakia
facility: GSK Investigational Site
city: Trencin
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: