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Phase 3 N=838 Randomized Triple-blind Prevention

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

Influenza · Influenza Vaccines

Enrolled (actual)
838
Serious AEs
1.4%
Results posted
Mar 2014
Primary outcome: Primary: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. — 175; 184; 201; 0 Subject

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Influenza A (H5N1) Virus monovalent vaccine (Biological); Saline placebo (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
1; 2; 1; 0; 0; 0
SECONDARY
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
5.3; 5.6; 5.7; 5.3; 5.6; 5.4
SECONDARY
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
1; 2; 1; 0; 0; 0
SECONDARY
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
53; 45; 23; 0; 0; 0
SECONDARY
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
12.1; 5.5; 3.6; 1.0; 0.9; 1.0
SECONDARY
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
5.3; 5.6; 5.7; 5.3; 5.6; 5.4
SECONDARY
Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
1; 2; 1; 0; 0; 0
SECONDARY
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain
777.1; 543.8; 416.2; 5.1; 5.4; 5.8
SECONDARY
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
53; 45; 23; 0; 0; 0
SECONDARY
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
12.1; 5.5; 3.6; 1.0; 0.9; 1.0
SECONDARY
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
5.3; 5.6; 5.7; 5.3; 5.6; 5.4
SECONDARY
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
1; 2; 1; 0; 0; 0
SECONDARY
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
53; 45; 23; 0; 0; 0
SECONDARY
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
12.1; 5.5; 3.6; 1.0; 0.9; 1.0
SECONDARY
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
14.00; 15.67; 15.54; 15.46; 14.00; 14.91
SECONDARY
Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.
0; 6; 5; 1; 0; 1
SECONDARY
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
34; 37; 39; 0; 0; 0
SECONDARY
Number of Subjects Reporting Solicited Local Symptoms.
111; 8; 6; 0; 5; 0
SECONDARY
Number of Subjects Reporting Solicited Local Symptoms.
111; 8; 6; 0; 5; 0
SECONDARY
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
23; 1; 17; 28; 1; 23
SECONDARY
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
23; 1; 17; 28; 1; 23
SECONDARY
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
18; 1; 13; 7; 0; 5
SECONDARY
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
18; 1; 13; 7; 0; 5
SECONDARY
Number of Subjects With Medically-attended Adverse Events (MAEs)
36
SECONDARY
Number of Subjects With Medically-attended Adverse Events (MAEs)
36
SECONDARY
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
SECONDARY
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
SECONDARY
Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
SECONDARY
Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
SECONDARY
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)
15; 4; 0; 0; 586; 221
SECONDARY
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)
15; 4; 0; 0; 587; 224
SECONDARY
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)
15; 4; 142; 61; 447; 165
SECONDARY
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)
29; 12; 0; 0; 576; 219
SECONDARY
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)
26; 10; 53; 21; 480; 181
SECONDARY
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)
29; 12; 26; 10; 534; 202
SECONDARY
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)
29; 12; 7; 1; 441; 161
SECONDARY
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)
26; 10; 25; 4; 504; 198
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Serious Adverse Events (SAEs)
2
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
41
SECONDARY
Number of Subjects Reporting Serious Adverse Events (SAEs)
2

Summary

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

Eligibility Criteria

Inclusion Criteria

  • A male or female child >= 6 months and = 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01310413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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