Clinical trial NCT00971321: Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza infection
GSK Bio's influenza vaccine GSK2340272A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 157
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
* Written informed consent obtained from the parent(s) or LAR(s) of the subject.
* Healthy children, as established by medical history and clinical examination when entering the study.
* 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.

Exclusion Criteria:

* 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.
* Clinically or virologically confirmed influenza infection within six months preceding the study start.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
* History of any neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
* Child in Care.

Primary outcomes:
measure: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 0
measure: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 42
measure: Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 0
measure: Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 42
measure: Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 42
measure: Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 42
measure: Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Day 42
Secondary outcomes:
measure: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Days 0, 21, 42, and at Month 11-12
measure: Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Days 0, 21, 42 and at Month 11-12
measure: Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Days 21, 42 and at Month 11-12
measure: Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
timeFrame: At Days 0, 21, 42 and at Month 11-12
measure: Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
timeFrame: At Days 21, 42 and at Month 11-12
measure: Titers for Serum Neutralising Antibodies
timeFrame: At Days 0, 21 and 42
measure: Titers for Serum Neutralising Antibodies
timeFrame: At Days 0, 21, 42 and at Month 11-12
measure: Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
timeFrame: At Days 21 and 42
measure: Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
timeFrame: At Days 21, 42 and at Month 11-12
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
measure: Number of Subjects With Any Medically-attended Events (MAEs)
timeFrame: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)
measure: Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)
timeFrame: During the entire study period (Day 0 up to Month 11-12)
measure: Number of Subjects With Normal/Abnormal Biochemical Levels
timeFrame: At Days 0, 21 and 42
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 up to Month 11-12)
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Móstoles/Madrid
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
citation: Carmona A, Omenaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Aristegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. doi: 10.1016/j.vaccine.2010.06.065. Epub 2010 Jun 29.