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Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

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

Condition(s) targeted: Influenza

Intervention: FluLaval® Quadrivalent (Biological); Fluzone® (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 this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Clinical Details

Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age

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

Primary outcome: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.

Secondary outcome:

Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.

Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains

Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.

Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.

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

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

Number of Subjects Reporting Any, Grade 3 and Related Fever

Duration of Solicited Local and General Symptoms

Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)

Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)

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

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

Detailed description: The subjects will be randomised (1: 1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.

Eligibility

Minimum age: 6 Months. Maximum age: 35 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion

of the investigator, can and will comply, with the requirements of the protocol.

- A male or female between, and including, 6 and 35 months of age at the time of the

first vaccination.

- Written informed consent obtained from the parent(s)/LAR(s) of the subject.

- Subjects in stable health as determined by investigator's clinical examination and

assessment of subject's medical history.

- Subjects are eligible regardless of history of administration of influenza vaccine in

a previous season. 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. Routine registered childhood vaccinations are permitted.

- Child in care.

- Chronic administration of immunosuppressants or other immune-modifying drugs within

six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0. 5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

- Prior receipt of any seasonal or pandemic influenza vaccine within six months

preceding the first dose of study vaccine, or planned use during the study period.

- Administration of immunoglobulins and/or any blood products within the three months

preceding the first dose of study vaccine or planned administration during the study period.

- History of Guillain-Barré syndrome within six weeks of receipt of prior influenza

vaccine.

- Any known or suspected allergy to any constituent of influenza vaccines; a history of

anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.

- Acute disease and/or fever at the time of enrollment.

- Fever is defined as temperature ≥ 38. 0°C/100. 4°F by any method.

- Subjects with a minor illness without fever may be enrolled at the discretion of

the investigator.

- Any significant disorder of coagulation or treatment with warfarin derivatives or

heparin.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on

medical history and physical examination.

- Any other condition which, in the opinion of the investigator, prevents the subject

from participating in the study.

Locations and Contacts

GSK Investigational Site, Sacramento, California 95822, United States

GSK Investigational Site, West Covina, California 91790, United States

GSK Investigational Site, Altamonte Springs, Florida 32701, United States

GSK Investigational Site, Fall River, Massachusetts 02721, United States

GSK Investigational Site, Woburn, Massachusetts 01801, United States

GSK Investigational Site, Stevensville, Michigan 49127, United States

GSK Investigational Site, Syracuse, New York 13210, United States

GSK Investigational Site, Cleveland, Ohio 44121, United States

GSK Investigational Site, Hermitage, Pennsylvania 16148, United States

GSK Investigational Site, Barnwell, South Carolina 29812, United States

GSK Investigational Site, Cheraw, South Carolina 29520, United States

GSK Investigational Site, Fort Worth, Texas 76135, United States

Additional Information

Starting date: October 2013
Last updated: April 9, 2015

Page last updated: August 20, 2015

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