Clinical trial NCT00985790: Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
Official title: Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine GSK2321138A in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: vaccine
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.


Eligibility criteria: Inclusion Criteria:

For all subjects:

* Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/from the LAR(s).

For unprimed subjects:

* A male or female child aged 18 to 47 months at the time of the first vaccination.
* Children who did not have influenza vaccine in a previous season.

For primed subjects from study NCT00764790:

• Children who received Fluarix™ in the 111751 study NCT00764790.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* History of hypersensitivity to any vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Acute disease at the time of enrolment.
* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
timeFrame: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Days 0 and 28.
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Days 0, 28 and Day 56
measure: Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Days 0 and 28
measure: Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Days 0, 28 and 56
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Day 28
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Days 28 and 56
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Day 28
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Days 28 and 56
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Days 0 and 28
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
timeFrame: At Days 0, 28 and 56
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day follow-up period (Days 0 to 6) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 28-day follow-up period (Days 0 to 27) after vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs).
timeFrame: From Day 0 to Day 180 (study conclusion)
measure: Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
timeFrame: From Day 0 to Day 180 (study conclusion)
Other outcomes:
Locations:
city: Ecatepec de Morelos
country: Mexico
facility: GSK Investigational Site
state: Estado De México
city: Mexico city
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rodriguez Weber MA, Claeys C, Aranza Doniz C, Feng Y, Innis BL, Jain VK, Peeters M. Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. Pediatr Infect Dis J. 2014 Dec;33(12):1262-9. doi: 10.1097/INF.0000000000000463.