Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01310413
First received: February 24, 2011
Last updated: February 13, 2014
Last verified: January 2014
  Purpose

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to < 18 years of age.


Condition Intervention Phase
Influenza
Biological: Pumarix™
Biological: Saline placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 42. ] [ Designated as safety issue: No ]
    A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

  • Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain [ Time Frame: At Day 42. ] [ Designated as safety issue: No ]
    HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.


Secondary Outcome Measures:
  • Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

  • Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
    A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

  • Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 21 and 42 ] [ Designated as safety issue: No ]
    A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 21 and 42 ] [ Designated as safety issue: No ]
    GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.

  • Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 0 and Day 182. ] [ Designated as safety issue: No ]
    HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

  • Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 0 and Day 182 ] [ Designated as safety issue: No ]
    A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

  • Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 182 ] [ Designated as safety issue: No ]
    A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 182 ] [ Designated as safety issue: No ]
    GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.

  • Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 385 ] [ Designated as safety issue: No ]
    HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

  • Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 385 ] [ Designated as safety issue: No ]
    A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

  • Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 385 ] [ Designated as safety issue: No ]
    A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Day 385. ] [ Designated as safety issue: No ]
    GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.

  • Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 0, 21 ,42, 182 and 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Seroprotected as Regards Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 0, 21 ,42, 182 and 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 0, 21 ,42, 182 and 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain. [ Time Frame: At Days 21 ,42, 182 and 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects Reporting Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, for each dose ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity or relationship to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, for each dose ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, for each dose ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Medically-attended Adverse Events (MAEs) [ Time Frame: From Day 0 up to Day 182 ] [ Designated as safety issue: No ]
    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects With Medically-attended Adverse Events (MAEs) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: From Day 0 up to Day 182 ] [ Designated as safety issue: No ]
    Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies [ Time Frame: From Day 0 up to Day 182 ] [ Designated as safety issue: No ]
    As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) and Alanine Aminotransferase (ALT) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (C-BIL) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo ] [ Designated as safety issue: No ]
    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) post-vaccination period following Dose 2 of vaccine/placebo ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo ] [ Designated as safety issue: No ]
    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to Day 182 ] [ Designated as safety issue: No ]
    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to Day 385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of Pumarix™ at Days U0 and U21, across doses ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Solicited Local Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of Pumarix™ at Days U0 and U21, for each dose ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of Pumarix™ at Days U0 and U21, across doses ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Solicited General Symptoms. [ Time Frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, for each dose ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Medically-attended Adverse Events (MAEs). [ Time Frame: From Day U0 upto Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) and Alanine Aminotransferase (ALT). [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (C-BIL) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) post-vaccination period following Dose 1 of Pumarix™ in the Unblinded Phase of the study ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 21-day (Days 0-20) post-vaccination period following Dose 2 of Pumarix™ in the Unblinded Phase of the study ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 42-day (Days 0-41) post-vaccination period following Dose 1 of Pumarix™ in the Unblinded Phase of the study ] [ Designated as safety issue: No ]
    Results will be posted when they become available.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Day U0 up to Day U385 ] [ Designated as safety issue: No ]
    Results will be posted when they become available.


Enrollment: 842
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pumarix 6-<36M Group
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Pumarix™ (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Pumarix™ was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Pumarix™
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Pumarix 3-<9Y Group
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Pumarix™ (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Pumarix™ was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Pumarix™
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Pumarix 9-<18Y Group
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Pumarix™ (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Pumarix™ was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Pumarix™
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 6-<36M Group
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 3-<9Y Group
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 9-<18Y Group
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Placebo/Pumarix Group
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Pumarix™ at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Pumarix™ was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Biological: Pumarix™
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Biological: Saline placebo
All subjects will receive 2 doses administered as an intramuscular (IM) injection.

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child >= 6 months and < 18 years of age at the time of first vaccination.
  • Written informed consent obtained from the subject's parent/guardian.
  • Documentation of assent for children 9 to < 18 years of age (or as deemed mandatory by local practice).
  • Satisfactory baseline medical assessment by history and physical examination
  • Parent/guardian and subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Parents/guardians and subjects who the investigator believes understand the requirements of the protocol and can and will comply with them.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential must

    • have practiced adequate contraception for 30 days prior to vaccination, and
    • have a negative pregnancy test on the day of each vaccination, and
    • have agreed to continue adequate contraception for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Medical history of physician-confirmed infection with an H5N1 virus.
  • Previous vaccination at any time with an H5N1 vaccine.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject or parent/guardian unable/unlikely to provide accurate safety reports.
  • Evidence of current subject or parent/guardian substance abuse, including alcohol, by medical history.
  • Presence of a temperature >= 38.0ºC by any method, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Receipt of systemic glucocorticoids within 1 month prior to first dose of test article or any other cytotoxic or immunosuppressive drug within 6 months prior to first dose of test article. Receipt of any immunoglobulins and/or any blood products within 3 months of first test article administration or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
  • Administration of an inactivated seasonal influenza vaccine within 14 days, or of a live, attenuated seasonal influenza vaccine within 30 days before the first test article dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first test article dose.
  • Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the "Day 42" visit.
  • Any known or suspected allergy to any constituent of influenza vaccines or history of severe reaction to any previous influenza vaccination.
  • Known pregnancy, or a positive urine pregnancy test result prior to each test article dose.
  • Lactating or nursing.
  • Child in care.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310413

Locations
United States, California
GSK Investigational Site
Paramount, California, United States, 90723
GSK Investigational Site
Sacramento, California, United States, 95816
United States, Kansas
GSK Investigational Site
Newton, Kansas, United States, 67114
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68134
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89014
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
United States, Texas
GSK Investigational Site
Fort Worth, Texas, United States, 76135
GSK Investigational Site
San Angelo, Texas, United States, 76904
Canada, British Columbia
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 2G2
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Thailand
GSK Investigational Site
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Kosalaraksa P et al. Immunogenicity and Safety of an AS03-Adjuvanted H5N1 Vaccine in Children 6 Months to <18 Years of Age: a Randomized Multi-center Trial. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01310413     History of Changes
Other Study ID Numbers: 114464
Study First Received: February 24, 2011
Results First Received: January 9, 2014
Last Updated: February 13, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Influenza
H5N1
Pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014