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

NCT01196988 | Completed Phase 3 Results

• 1 other identifier: 113275
• Study Type: interventional
• Target: 3,027
• Locations: 5 countries
• Sites: 59

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

Keywords

GSK Biologicals influenza vaccine GSK2321138A; influenza infection

Outcome Measures

Primary Outcomes (2)

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

  Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

  At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

  At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Secondary Outcomes (25)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

  At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

  At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

  At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

  At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

• Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

  At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Study Arms (4)

GSK2321138A 1 Group

EXPERIMENTAL

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.

Biological: Influenza vaccine GSK2321138A

Fluarix Group

ACTIVE COMPARATOR

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.

Biological: FluarixTM

GSK2604409A Group

ACTIVE COMPARATOR

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.

Biological: Influenza vaccine GSK2604409A

GSK2321138A 2 Group

EXPERIMENTAL

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.

Biological: Influenza vaccine GSK2321138A

Interventions

Influenza vaccine GSK2321138A BIOLOGICAL

intramuscular injections

GSK2321138A 1 Group; GSK2321138A 2 Group

FluarixTM BIOLOGICAL

intramuscular injections

Fluarix Group

Influenza vaccine GSK2604409A BIOLOGICAL

intramuscular injections

GSK2604409A Group

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (59)

GSK Investigational Site

Sacramento, California, 95816, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33432, United States

Location

GSK Investigational Site

Wichita, Kansas, 67205, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02130, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Elmira, New York, 14901, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Houston, Texas, 77055, United States

Location

GSK Investigational Site

San Angelo, Texas, 76904, United States

Location

GSK Investigational Site

Děčín, 405 01, Czechia

Location

GSK Investigational Site

Humpolec, 396 01, Czechia

Location

GSK Investigational Site

Jindřichův Hradec, 37701, Czechia

Location

GSK Investigational Site

Kolín, 28002, Czechia

Location

GSK Investigational Site

Náchod, 547 01, Czechia

Location

GSK Investigational Site

Odolena Voda, 25070, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Pilsen, 305 99, Czechia

Location

GSK Investigational Site

Prague, 1600, Czechia

Location

GSK Investigational Site

Tábor, 390 02, Czechia

Location

GSK Investigational Site

Aix-en-Provence, 13100, France

Location

GSK Investigational Site

Draguignan, 83300, France

Location

GSK Investigational Site

Essey-lès-Nancy, 54270, France

Location

GSK Investigational Site

La Bouëxière, 35340, France

Location

GSK Investigational Site

Le Havre, 76600, France

Location

GSK Investigational Site

Nantes, 44300, France

Location

GSK Investigational Site

Nice, 06300, France

Location

GSK Investigational Site

Seysses, 31600, France

Location

GSK Investigational Site

Tours, 37100, France

Location

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, 77955, Germany

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany

Location

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

GSK Investigational Site

Gilching, Bavaria, 82205, Germany

Location

GSK Investigational Site

Kirchheim, Bavaria, 85551, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Eschwege, Hesse, 37269, Germany

Location

GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

Location

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

Location

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

Location

GSK Investigational Site

Willich, North Rhine-Westphalia, 47877, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, 10967, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Hamburg, 22307, Germany

Location

GSK Investigational Site

Dasmariñas, Cavite, 4114, Philippines

Location

GSK Investigational Site

Quezon City, 1113, Philippines

Location

Related Publications (1)

• 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.

  PMID: 23470848 DERIVED

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: October 4, 2010
• Primary Completion: June 15, 2011
• Study Completion: June 15, 2011
• Last Updated: September 21, 2018
• Results First Posted: March 19, 2013

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (9); US (14); CZ (10); DE (24); PH (2)