A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Time frame: At Day 192.

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Time frame: From Day 0 to Day 182

Population: The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.

Any = occurrence of the symptom regardless of intensity grade.

Time frame: From Day 0 to Day 364.

Population: The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.

Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Time frame: At Days 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.

Time frame: At Days 0, 42, 182, 192, 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.

Time frame: At Days 0, 42, 182, 192, 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364.

Time frame: At Days 42, 182, 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.

Time frame: At Days 42, 182, 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Time frame: At Days 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192.

Time frame: At Days 0,42, 182, 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364.

Time frame: At Days 0, 42, 182, 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature\[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.

Time frame: During a 7-day (Day 0-6) follow-up period after vaccination

Population: The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.

Time frame: During a 7-day (Day 0-6) follow-up period after each vaccination

Population: The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

Time frame: During a 7-day (Day 0-6) follow-up period after each vaccination

Population: The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Time frame: During Day 0 to Telephone Contact (TC) Day 84 overall.

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Time frame: During a 21-day (Days 0 - 20) follow-up period after vaccination

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Time frame: During the entire study period (Day 0 to 364)

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Time frame: At Days 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364.

Time frame: At Days 0, 42, 182 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: During the entire study period (Day 0 to 364)

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Time frame: At Days 42, 182 192 and 364

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.