Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

NCT ID: NCT01196988

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3027 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-04
• Study Completion Date: 2011-06-15

Brief Summary

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

Conditions

Influenza

Study Design

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

Study Groups

GSK2321138A 1 Group

Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2321138A

Intervention Type: BIOLOGICAL

intramuscular injections

Fluarix Group

Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Group Type: ACTIVE_COMPARATOR

FluarixTM

Intervention Type: BIOLOGICAL

intramuscular injections

GSK2604409A Group

Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Group Type: ACTIVE_COMPARATOR

Influenza vaccine GSK2604409A

Intervention Type: BIOLOGICAL

intramuscular injections

GSK2321138A 2 Group

Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Group Type: EXPERIMENTAL

Influenza vaccine GSK2321138A

Intervention Type: BIOLOGICAL

intramuscular injections

Interventions

Influenza vaccine GSK2321138A

intramuscular injections

Intervention Type: BIOLOGICAL

FluarixTM

intramuscular injections

Intervention Type: BIOLOGICAL

Influenza vaccine GSK2604409A

intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• For non US countries:
• - Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.

For US :

• Children, male or female, aged between 3 and 17 years at the time of the first study vaccination
• Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
• Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
• Written informed assent obtained from the subject if/as required by local regulations.
• 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 urine 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 vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) 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 three months prior to enrolment in this study or planned administration during the study period.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of seizures or progressive neurological disease.
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• 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 a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
• Acute disease and/or fever at the time of enrolment
• Ongoing aspirin therapy
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
• Child in Care.

• Minimum Eligible Age: 6 Months
• 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

Sacramento, California, United States

GSK Investigational Site

Boca Raton, Florida, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Binghamton, New York, United States

GSK Investigational Site

Elmira, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Angelo, Texas, United States

GSK Investigational Site

Děčín, , Czechia

GSK Investigational Site

Humpolec, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Kolín, , Czechia

GSK Investigational Site

Náchod, , Czechia

GSK Investigational Site

Odolena Voda, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Tábor, , Czechia

GSK Investigational Site

Aix-en-Provence, , France

GSK Investigational Site

Draguignan, , France

GSK Investigational Site

Essey-lès-Nancy, , France

GSK Investigational Site

La Bouëxière, , France

GSK Investigational Site

Le Havre, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Nice, , France

GSK Investigational Site

Seysses, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Gilching, Bavaria, Germany

GSK Investigational Site

Kirchheim, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Eschwege, Hesse, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Dasmariñas, Cavite, , Philippines

GSK Investigational Site

Quezon City, , Philippines

Countries

United States; Czechia; France; Germany; Philippines

References

Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

Reference Type: DERIVED

PMID: 23470848 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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

View Document

Document Type: Study Protocol

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: Informed Consent Form

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: Annotated Case Report Form

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

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

113275

Identifier Type: -

Identifier Source: org_study_id