Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

NCT00502593 | Completed Phase 2 Results

• 3 other identifiers: 107066108498108500
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 7

Brief Summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Influenza

Keywords

Influenza; Pandemic Influenza Vaccine (GSK1562902A)

Outcome Measures

Primary Outcomes (65)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.

  At Day 0

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10

  At Day 21

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10

  At Day 42

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.

  At Month 6

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10

  At Month 12

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10

  At Month 24

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

  A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (\<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Day 21

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

  A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Day 42

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

  A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Month 6

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

  A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Month 12

• Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

  A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Month 24

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Day 21

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Day 42

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

  At Month 6

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Month 12

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Month 24

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Day 0

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Day 21

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Day 42

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)

  At Month 6

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)

  At Month 12

• Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

  A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

  At Month 24

• Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

  Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.

  During the 7 day follow-up period after each vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

  Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.

  During the 7-day follow-up period after each vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature \> 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.

  During the 7-day (Days 0-6) follow-up period after any vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.

  During the 7-day (Days 0-6) follow-up period after any vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

  Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.

  During the 7-day follow-up period after each vaccination

• Number of Subjects With Serious Adverse Events (SAEs)

  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. Any SAE = any SAE regardless of intensity or relationship to vaccination.

  During the entire study (Day 0 to Month 24)

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events

  An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.

  During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A

  Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.

  At Days 21 and 42 and Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C

  Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C

  Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.

  At Days 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.

  At Days 0, 21 and 42 and at Month 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.

  At Days 0, 21 and 42 and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.

  At Days 0, 21, and 42, and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.

  At Days 0, 21 and 42 and at Months 6, 12 and 24

• Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C

  Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.

  At Days 0, 21 and 42 and at Months 6, 12 and 24

Secondary Outcomes (9)

• Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

  At Days 0, 21 and 42

• Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

  At Days 0, 21 and 42

• Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

  At Days 0, 21 and 42

• Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies

  At Days 21 and 42

• Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies

  At Days 21 and 42

Study Arms (12)

GSK1562902A-A Lot 1 3-5Y Group

EXPERIMENTAL

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-A 3-5Y Group

ACTIVE COMPARATOR

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

GSK1562902A-A Lot 1 6-9Y Group

EXPERIMENTAL

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-A 6-9Y Group

ACTIVE COMPARATOR

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

GSK1562902A-B Lot 2 3-5Y Group

EXPERIMENTAL

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-B 3-5Y Group

ACTIVE COMPARATOR

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

GSK1562902A-B Lot 2 6-9Y Group

EXPERIMENTAL

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-B 6-9Y Group

ACTIVE COMPARATOR

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

GSK1562902A-C Lot 3 3-5Y Group

EXPERIMENTAL

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-C 3-5Y Group

ACTIVE COMPARATOR

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

GSK1562902A-C Lot 3 6-9Y Group

EXPERIMENTAL

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Fluarix-C 6-9Y Group

ACTIVE COMPARATOR

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Biological: Fluarix™

Interventions

Pandemic Influenza Vaccine (GSK1562902A) BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

GSK1562902A-A Lot 1 3-5Y Group; GSK1562902A-A Lot 1 6-9Y Group; GSK1562902A-B Lot 2 3-5Y Group; GSK1562902A-B Lot 2 6-9Y Group; GSK1562902A-C Lot 3 3-5Y Group; GSK1562902A-C Lot 3 6-9Y Group

Fluarix™ BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

Fluarix-A 3-5Y Group; Fluarix-A 6-9Y Group; Fluarix-B 3-5Y Group; Fluarix-B 6-9Y Group; Fluarix-C 3-5Y Group; Fluarix-C 6-9Y Group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Children aged between and including 3 and 9 years of age at the time of first vaccination.
• Written informed consent obtained from the parent(s) or guardian of the subject.
• Healthy children as established by medical history and clinical examination before entering the study.
• Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
• Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
• Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
• Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
• 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 used in this study.
• History of any neurological disorders or seizures.
• Acute disease at the time of enrolment.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Blanes (Girona), 17300, Spain

Location

GSK Investigational Site

L'Eliana, Valencia, 46183, Spain

Location

GSK Investigational Site

Paiporta, Valencia, 46200, Spain

Location

GSK Investigational Site

Quart de Poblet, Valencia, 46930, Spain

Location

GSK Investigational Site

Valencia, 46008, Spain

Location

GSK Investigational Site

Valencia, 46011, Spain

Location

GSK Investigational Site

Valencia, 46024, Spain

Location

Related Publications (2)

• Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, Vanden Abeele C, Gillard P. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015 Mar;9(2):68-77. doi: 10.1111/irv.12295. Epub 2015 Feb 5.

  PMID: 25652873 DERIVED

• Diez-Domingo J, Garces-Sanchez M, Baldo JM, Planelles MV, Ubeda I, JuBert A, Mares J, Moris P, Garcia-Corbeira P, Drame M, Gillard P. Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase ii, randomized, open, controlled study. Pediatr Infect Dis J. 2010 Jun;29(6):e35-46. doi: 10.1097/INF.0b013e3181daf921.

  PMID: 20375709 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: July 23, 2007
• Primary Completion: December 4, 2009
• Study Completion: December 4, 2009
• Last Updated: October 25, 2018
• Results First Posted: June 3, 2014

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (7)