The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4
Intramuscular injections
Intramuscular injections
Intramuscular injections
GSK Investigational Site
Seville, Spain
Serum Haemagglutination-inhibition (HI) Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Time frame: at Day 28/ Day 56
Serum Neutralizing Antibody Titers
Time frame: at Day 28/ Day 56
Geometric Mean Number of All-CD4 Cytokine Positive Cells
Geometric mean of the number of CD4 cytokine positive T cells per million T cells.
Time frame: at Day 28/ Day 56
Number of Subjects Reporting Fever of at Least Grade 2 or Higher
Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
Time frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Serum HI Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Time frame: on Days 0, 28/56 and 180
Serum Neutralising Antibody Titers
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
Time frame: on Days 0, 28/56 and 180
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.
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Time frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: within 28 days (Day 0 to Day 27) after any vaccination
Number of Subjects Reporting Adverse Events With Medically Attended Visits
A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Time frame: From Day 0 to 179
Number of Subjects Reporting Potential Immune-mediated Diseases
Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time frame: From Day 0 to 179
Number of Subjects Reporting Serious Adverse Events
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 to 179