This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
468
GSK Investigational Site
Phoenix, Arizona, United States
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Time frame: 31 days following the second dose of Havrix™
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as International Units per milliliter (IU/mL).
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as microgram/milliliter (µg/mL).
Time frame: 31 days following the administration of Infanrix™ and ActHIB
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GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
San Ramon, California, United States
GSK Investigational Site
Wilmington, Delaware, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Martinez, Georgia, United States
GSK Investigational Site
Waterloo, Iowa, United States
GSK Investigational Site
Bossier City, Louisiana, United States
GSK Investigational Site
Long Branch, New Jersey, United States
GSK Investigational Site
Ithaca, New York, United States
...and 12 more locations
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Time frame: 31 days following the first dose of Havrix™
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Time frame: 31 days following the first dose of Havrix™
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Time frame: 31 days following the second dose of Havrix™
Number of Subjects With Vaccine Response to Havrix™.
Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.
Time frame: 31 days following the second dose
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.
Time frame: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.
Time frame: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: 31-day period following each dose of study vaccine(s)
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.
Time frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.