Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

NCT ID: NCT00980005

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-13
• Study Completion Date: 2010-06-17

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

• 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
• 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.

Group Type: EXPERIMENTAL

GSK investigational vaccine GSK1557482A

Intervention Type: BIOLOGICAL

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Fluzone Group

subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:

• 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
• 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.

Group Type: ACTIVE_COMPARATOR

Fluzone®

Intervention Type: BIOLOGICAL

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Interventions

GSK investigational vaccine GSK1557482A

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Intervention Type: BIOLOGICAL

Fluzone®

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
• A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
• Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
• 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 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

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
• Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
• Child in care
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
• 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.
• History of hypersensitivity to any vaccine.
• History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Acute disease and/or fever at the time of enrolment.
• 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.
• Pregnant or lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Woodstock, Georgia, United States

GSK Investigational Site

DeKalb, Illinois, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Woburn, Massachusetts, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Cortland, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Austintown, Ohio, United States

GSK Investigational Site

Albany, Oregon, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Hermitage, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Orem, Utah, United States

GSK Investigational Site

Provo, Utah, United States

GSK Investigational Site

Burke, Virginia, United States

Countries

United States

References

Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.

Reference Type: DERIVED

PMID: 29465480 (View on PubMed)

Domachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.

Reference Type: DERIVED

PMID: 22333695 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112999

Identifier Type: -

Identifier Source: org_study_id