Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
2 other identifiers
interventional
842
3 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedStudy Start
First participant enrolled
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2014
CompletedResults Posted
Study results publicly available
March 31, 2014
CompletedNovember 1, 2021
October 1, 2021
5 months
February 24, 2011
January 9, 2014
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
At Day 42.
Secondary Outcomes (44)
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
At Days 0 and 21
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
At Days 0 and 21
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
At Days 21 and 42
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
At Days 21 and 42
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
At Day 0 and Day 182.
- +39 more secondary outcomes
Study Arms (7)
Influenza A (H5N1) adjuvanted 6-<36M Group
EXPERIMENTALSubjects 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).
Influenza A (H5N1) Virus monovalent vaccine 3-<9Y Group
EXPERIMENTALSubjects 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).
Influenza A (H5N1) Virus monovalent vaccine 9-<18Y Group
EXPERIMENTALSubjects 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).
Placebo 6-<36M Group
PLACEBO 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).
Placebo 3-<9Y Group
PLACEBO 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).
Placebo 9-<18Y Group
PLACEBO 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).
Placebo/Influenza A (H5N1) adjuvanted Group
EXPERIMENTALSubjects 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.
Interventions
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Fort Worth, Texas, 76135, United States
GSK Investigational Site
San Angelo, Texas, 76904, United States
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Hamilton, Ontario, L8L 5G8, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1J 2G2, Canada
GSK Investigational Site
Khon Kaen, 40002, Thailand
Related Publications (2)
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.
BACKGROUNDKosalaraksa 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.
PMID: 25293368BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2011
First Posted
March 8, 2011
Study Start
March 7, 2011
Primary Completion
July 21, 2011
Study Completion
January 26, 2014
Last Updated
November 1, 2021
Results First Posted
March 31, 2014
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.