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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

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

Condition(s) targeted: Influenza, Human; Seasonal Influenza

Intervention: Quadrivalent seasonal influenza vaccine GSK2282512A (Biological); Fluarix™ VB (Biological); Fluarix™ YB (Biological); Quadrivalent seasonal influenza vaccine GSK2282512A (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Clinical Details

Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

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

Primary outcome:

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

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease

Secondary outcome:

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

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease

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

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata

Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata

Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata

Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

Number of Days With Solicited Local Symptoms After Vaccination

Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms

Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age

Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above

Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination

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

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination

Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination

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

Eligibility

Minimum age: 6 Months. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who the investigator believes that they and/or their parent(s) or legally

acceptable representative(s) can and will comply with the requirements of the protocol.

- A male or female child aged between 6 months and 17 years inclusive at the time of

the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.

- Written informed consent obtained from the subject/from the parent(s)/legally

acceptable representative(s) of the subject.

- Written informed assent obtained from the subject if/as required by local

regulations.

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

assessment of subjects' medical history.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the

subject

- Has practiced adequate contraception for 30 days prior to vaccination, and

- Has a negative pregnancy urine test on the day of vaccination, and

- Has agreed to continue adequate contraception during the entire treatment period

and for 2 months after completion of the vaccination series. Exclusion Criteria:

- Child in care

- Use of any investigational or non-registered product other than the study vaccines

within 30 days preceding the first dose of study vaccine, or planned use during the study period. Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.

- Chronic administration of immunosuppressants or other immune modifying drugs within

six months prior to the first vaccine dose.

- Administration of immunoglobulins and/or any blood products within the 3 months

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

- History of Guillain-Barré syndrome within 6 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.

- Fever at the time of enrolment.

- Acute disease at the time of enrolment.

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

heparin.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive

precautions.

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

medical history and physical examination.

- Ongoing aspirin therapy.

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

from participating in the study.

Locations and Contacts

GSK Investigational Site, Mexico city 04530, Mexico

GSK Investigational Site, Alcala de Guadaira 41500, Spain

GSK Investigational Site, Madrid 28046, Spain

GSK Investigational Site, Pozuelo de Alarcón/Madrid 28223, Spain

GSK Investigational Site, Sevilla 41014, Spain

GSK Investigational Site, Taichung 404, Taiwan

GSK Investigational Site, Taipei 100, Taiwan

GSK Investigational Site, Edmonton, Alberta T6G 2C8, Canada

GSK Investigational Site, Chandler, Arizona 85224, United States

GSK Investigational Site, Scottsdale, Arizona 85288, United States

GSK Investigational Site, Harrisburg, Arkansas 72432, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Surrey, British Columbia V3R 8P8, Canada

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Paramount, California 90723, United States

GSK Investigational Site, Centennial, Colorado 80112, United States

GSK Investigational Site, Longmont, Colorado 80501, United States

GSK Investigational Site, Thornton, Colorado 80233, United States

GSK Investigational Site, Winnipeg, Manitoba R3A 1M3, Canada

GSK Investigational Site, Niles, Michigan 49120, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Mount Pearl, Newfoundland and Labrador A1N 5B6, Canada

GSK Investigational Site, Halifax, Nova Scotia B3K 6R8, Canada

GSK Investigational Site, Monterrey, Nuevo León 64460, Mexico

GSK Investigational Site, Brampton, Ontario L6T 0G1, Canada

GSK Investigational Site, Hamilton, Ontario L8L 5G8, Canada

GSK Investigational Site, Sudbury, Ontario P3E 1H5, Canada

GSK Investigational Site, Hermitage, Pennsylvania 16148, United States

GSK Investigational Site, Saskatoon, Saskatchewan S7K 3H3, Canada

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

GSK Investigational Site, Clarksville, Tennessee 37043, United States

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

Additional Information

Related publications:

Langley JM et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: a Randomized Controlled Trial in Children. Abstract presented at the 50th Annual Meeting, Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.

Starting date: October 2010
Last updated: February 7, 2013

Page last updated: August 20, 2015

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