Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

Phase 3TerminatedNCT01014091

GlaxoSmithKline60 enrolled

Overview

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Influenza

Interventions

GSK pandemic vaccine GSK2340272ABIOLOGICAL

2 intramuscular injections

Eligibility

Sex: ALLMin age: 3 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Children, male or female, aged between 3 and 9 years at the time of first study vaccination. * Written informed consent obtained from the parent(s) or LAR(s) of the subject. * Healthy children, as established by medical history and clinical examination when entering the study. Exclusion Criteria: * 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. * Clinically or virologically confirmed influenza infection within six months preceding the study start. * Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * Have received any seasonal flu vaccine since last year. * Previous administration of any H1N1 A/California-like vaccine * 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. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * 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. * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment: * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * Child in Care.

Locations (3)

GSK Investigational Site

Děčín, Czechia

GSK Investigational Site

Pardubice, Czechia

GSK Investigational Site

Prague, Czechia

Outcomes

Primary Outcomes

Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen

Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).

Time frame: At Day 42

Number of Seropositive Subjects for HI Antibodies

A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Day 42

Number of Seroconverted Subjects in Terms of HI Antibodies

Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Day 42

Number of Seroprotected Subjects for HI Antibodies

A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Day 42

Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Day 42

Secondary Outcomes

Number of Seropositive Subjects for HI Antibodies

A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.

Data from ClinicalTrials.gov

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