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
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