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Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Influenza vaccine GSK2321138A (Biological); Fluarix™ (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

Official title: Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine GSK2321138A in Healthy Children

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.

Secondary outcome:

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Number of Seropositive Subjects Against 4 Strains of Influenza Disease.

Number of Seropositive Subjects Against 4 Strains of Influenza Disease.

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

Number of Subjects With Any and Related Serious Adverse Events (SAEs).

Number of Subjects With Any Adverse Events of Specific Interest (AESIs).

Eligibility

Minimum age: 18 Months. Maximum age: 47 Months. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Mexico city 04530, Mexico

GSK Investigational Site, Ecatepec de Morelos, Estado de México 55075, Mexico

Additional Information

Starting date: October 2009
Last updated: July 2, 2015

Page last updated: August 20, 2015

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