Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

• Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
  Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
  
  
• Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  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.
  
  
• Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  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.
  
  

• Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  GMCs are expressed as International Units per milliliter (IU/mL).
  
  
• Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  GMCs are expressed as microgram/milliliter (µg/mL).
  
  
• Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ] [ Designated as safety issue: No ]
  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.
  
  
• Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix [ Time Frame: 31 days following the first dose of Havrix™ ] [ Designated as safety issue: No ]
  Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
  
  
• Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix [ Time Frame: 31 days following the first dose of Havrix™ ] [ Designated as safety issue: No ]
  Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
  
  
• Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix [ Time Frame: 31 days following the second dose of Havrix™ ] [ Designated as safety issue: No ]
  Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
  
  
• Number of Subjects With Vaccine Response to Havrix™. [ Time Frame: 31 days following the second dose ] [ Designated as safety issue: No ]
  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.
  
  
• Number of Subjects Reporting Solicited Local Adverse Events (AEs) [ Time Frame: 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.
  
  
• Number of Subjects Reporting Solicited General Adverse Events (AEs) [ Time Frame: 4-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.
  
  
• Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: 31-day period following each dose of study vaccine(s) ] [ Designated as safety issue: No ]
  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.
  
  
• Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events [ Time Frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. ] [ Designated as safety issue: No ]
  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.
  
  

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.