A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years
1 other identifier
interventional
520
1 country
2
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedStudy Start
First participant enrolled
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2012
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedSeptember 7, 2018
August 1, 2016
1 year
June 17, 2011
August 2, 2013
August 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
At Day 192.
Number of Subjects With Any Medically Attended Adverse Events (MAEs)
Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
From Day 0 to Day 182
Number of Subjects With Any Medically Attended Adverse Events (MAEs)
Any = occurrence of the symptom regardless of intensity grade.
From Day 0 to Day 364.
Secondary Outcomes (18)
H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
At Days 0, 42, 182, 192, 364
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
At Days 0, 42, 182, 192, 364
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
During a 7-day (Day 0-6) follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
During a 7-day (Day 0-6) follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
During a 7-day (Day 0-6) follow-up period after vaccination
- +13 more secondary outcomes
Study Arms (4)
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
EXPERIMENTALSubjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
EXPERIMENTALSubjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
ACTIVE COMPARATORSubjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
Havrix / Havrix Jr Group
ACTIVE COMPARATORSubjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
Interventions
Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Eligibility Criteria
You may qualify if:
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol .
- A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
- Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.
- Good general health as established by medical history and clinical examination before entering into the study.
- Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
You may not qualify if:
- Child in care
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- Active participation in other clinical trials.
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
- Acute disease and/or fever at the time of enrolment:
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
- History of seizures or progressive neurological disease.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Diagnosed with cancer or any chronic severe disease.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Alabang, Muntinlupa, 1781, Philippines
GSK Investigational Site
Quezon City, 1113, Philippines
Related Publications (1)
Izurieta P, Uy-Aragon MJ, Drame M, Vaughn DW. Assessment of Prime-boost Vaccination Using an AS03B-adjuvanted Influenza A (H5N1) Vaccine: A Randomized Trial in Children of Three to Less Than Eighteen Years of Age. Pediatr Infect Dis J. 2016 Feb;35(2):e35-47. doi: 10.1097/INF.0000000000000968.
PMID: 26551446DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 23, 2011
Study Start
July 28, 2011
Primary Completion
August 2, 2012
Study Completion
October 5, 2012
Last Updated
September 7, 2018
Results First Posted
March 26, 2014
Record last verified: 2016-08
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.