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AzTrials

InfluenzaPhase 3NCT01310413

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

A Phase 3 study testing Influenza A (H5N1) Virus monovalent vaccine in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Influenza Vaccines
What is being tested?
Influenza A (H5N1) Virus monovalent vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
842 participants
Where
17 sitesin 3 countries
Study dates
7 Mar 2011to 26 Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

United States11 sites

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Fort Worth, Texas, 76135

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    San Angelo, Texas, 76904

  • GSK Investigational Site

    St Louis, Missouri, 63141

Other trials in United States

Canada5 sites

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2

Other trials in Canada

Thailand1 site

  • GSK Investigational Site

    Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

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

Being tested
Influenza A (H5N1) Virus monovalent vaccine, Saline placebo
Keywords
Influenza, H5N1, Pandemic
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza A (H5N1) Virus monovalent vaccineBiological

    All subjects will receive 2 doses administered as an intramuscular (IM) injection.

  • Saline placeboBiological

    All subjects will receive 2 doses administered as an intramuscular (IM) injection.

Study groups in NCT01310413
Study groupRoleWhat they receive
Influenza A (H5N1) adjuvanted 6-<36M GroupExperimentalSubjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine 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).
Receives: Biological: Influenza A (H5N1) Virus monovalent vaccine
Influenza A (H5N1) Virus monovalent vaccine 3-<9Y GroupExperimentalSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine 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).
Receives: Biological: Influenza A (H5N1) Virus monovalent vaccine
Influenza A (H5N1) Virus monovalent vaccine 9-<18Y GroupExperimentalSubjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine 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).
Receives: Biological: Influenza A (H5N1) Virus monovalent vaccine
Placebo 6-<36M GroupPlacebo comparatorSubjects 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).
Receives: Biological: Saline placebo
Placebo 3-<9Y GroupPlacebo comparatorSubjects 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).
Receives: Biological: Saline placebo
Placebo 9-<18Y GroupPlacebo comparatorSubjects 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).
Receives: Biological: Saline placebo
Placebo/Influenza A (H5N1) adjuvanted GroupExperimentalSubjects 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 Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine 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.
Receives: Biological: Influenza A (H5N1) Virus monovalent vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Day 42.

Secondary outcomes (44)

  1. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Days 0 and 21

  2. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Days 0 and 21

  3. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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.

    As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

    Measured: At Days 21 and 42

  4. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Days 21 and 42

  5. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

    Measured: At Day 0 and Day 182.

  6. Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

    Measured: At Day 0 and Day 182

  7. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain

    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.

    As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

    Measured: At Day 42.

  8. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Day 182

  9. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Day 182

  10. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

    Measured: At Day 0 and Day 385

  11. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.

    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.

    As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

    Measured: At Day 0 and Day 385

  12. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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.

    Measured: At Day 385

  13. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    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 titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

    Measured: At Day 385.

  14. Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.

    MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.

    Measured: At Days 0, 42, 182 and 385

  15. Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.

    Measured: At Days 0 and 42

  16. Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.

    VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.

    Measured: At Day 42

  17. Number of Subjects Reporting Solicited Local Symptoms.

    Solicited local symptoms assessed were pain, redness and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).

    Measured: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

  18. Number of Subjects Reporting Solicited Local Symptoms.

    Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).

    Measured: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

  19. Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.

    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 general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.

    Measured: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

  20. Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.

    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 general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.

    Measured: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

  21. Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.

    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. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.

    Measured: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

  22. Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.

    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. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.

    Measured: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

  23. Number of Subjects With Medically-attended Adverse Events (MAEs)

    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.

    Measured: From Day 0 up to Day 385

  24. Number of Subjects With Medically-attended Adverse Events (MAEs)

    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.

    Measured: From Day U0 up to Day U385

  25. Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)

    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.

    Measured: From Day 0 up to Day 385

  26. Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)

    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.

    Measured: From Day U0 to Day U385

  27. Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies

    Measured: From Day 0 up to Day 385

  28. Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies

    Measured: From Day U0 to Day U385

  29. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  30. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  31. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  32. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  33. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  34. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  35. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  36. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

    Measured: From Day 0 up to Day 385

  37. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo

  38. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo

  39. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo

  40. Number of Subjects Reporting Serious Adverse Events (SAEs)

    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.

    Measured: From Day 0 up to Day 385

  41. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

  42. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine

  43. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    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.

    Measured: During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

  44. Number of Subjects Reporting Serious Adverse Events (SAEs)

    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.

    Measured: From Day U0 up to Day U385

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2011 (estimated)
  2. Study start7 Mar 2011
  3. Primary completion21 Jul 2011
  4. Study completion26 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
842 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310413
Sponsor's protocol ID
114464
Other IDs
2012-001683-29
Status last verified
Oct 2021
First submitted
24 Feb 2011
Last updated
1 Nov 2021
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Izurieta P et al. (2018) Reactogenicity and safety of AS03B-adjuvanted H5N1 influenza vaccine in children: an open-label, one-way, crossover trial. Asian Biomed (Res Rev News). 11(4):359-364.

  • Kosalaraksa P, Jeanfreau R, Frenette L, Drame M, Madariaga M, Innis BL, Godeaux O, Izurieta P, Vaughn DW. AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial. J Infect Dis. 2015 Mar 1;211(5):801-10. doi: 10.1093/infdis/jiu548. Epub 2014 Oct 6.

    PubMed 25293368

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza A (H5N1) Virus monovalent vaccine in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. (time frame: At Day 42.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01310413, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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