Clinical trial NCT01379937: A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Official title: Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza
H5N1
vaccine
children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 520
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

* 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.
* Previous administration of any H5N1 vaccine.

Primary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
timeFrame: At Day 192.
measure: Number of Subjects With Any Medically Attended Adverse Events (MAEs)
timeFrame: From Day 0 to Day 182
measure: Number of Subjects With Any Medically Attended Adverse Events (MAEs)
timeFrame: From Day 0 to Day 364.
Secondary outcomes:
measure: H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
timeFrame: At Days 0, 42, 182, 192, 364
measure: H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
timeFrame: At Days 0, 42, 182, 192, 364
measure: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
timeFrame: During a 7-day (Day 0-6) follow-up period after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During a 7-day (Day 0-6) follow-up period after each vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During a 7-day (Day 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During a 21-day (Days 0 - 20) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During Day 0 to Telephone Contact (TC) Day 84 overall.
measure: Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
timeFrame: During the entire study period (Day 0 to 364)
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Day 0 to 364)
measure: Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10
timeFrame: At Days 0, 42, 182, 192 and 364
measure: Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease
timeFrame: At Days 42, 182, 192 and 364
measure: Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
timeFrame: At Days 0,42, 182, 192 and 364
measure: Mean Geometric Increase for Anti-H5N1 Antibody Titers
timeFrame: At Days 42, 182, 192 and 364
measure: Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease
timeFrame: At Days 192 and 364
measure: Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease
timeFrame: At Days 192 and 364
measure: Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers
timeFrame: At Days 0, 42, 182 192 and 364
measure: Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies
timeFrame: At Days 42, 182 192 and 364
measure: Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies
timeFrame: At Days 192 and 364
Other outcomes:
Locations:
city: Alabang, Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.