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

NCT01198756 | Completed Phase 3 Results

• 1 other identifier: 113314
• Study Type: interventional
• Target: 3,109
• Locations: 5 countries
• Sites: 33

Brief Summary

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

Conditions

Influenza

Keywords

Influenza

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 the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

  At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

• Number of Subjects Seroconverted 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 vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

  At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Secondary Outcomes (18)

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

  At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

• Number of Subjects Seroprotected Against 4 Strains of Influenza Disease

  At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

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

  At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

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

  At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Study Arms (4)

GSK2282512A 1 Group

EXPERIMENTAL

Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Victoria strain Fluarix Group

ACTIVE COMPARATOR

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™ VB

Yamagata strain Fluarix Group

ACTIVE COMPARATOR

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™ YB

GSK2282512A 2 Group

EXPERIMENTAL

Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Interventions

Quadrivalent seasonal influenza vaccine GSK2282512A BIOLOGICAL

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

GSK2282512A 1 Group

Fluarix™ VB BIOLOGICAL

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

Victoria strain Fluarix Group

Fluarix™ YB BIOLOGICAL

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

Yamagata strain Fluarix 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (33)

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85288, United States

Location

GSK Investigational Site

Harrisburg, Arkansas, 72432, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Paramount, California, 90723, United States

Location

GSK Investigational Site

Centennial, Colorado, 80112, United States

Location

GSK Investigational Site

Longmont, Colorado, 80501, United States

Location

GSK Investigational Site

Thornton, Colorado, 80233, United States

Location

GSK Investigational Site

Niles, Michigan, 49120, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

Hermitage, Pennsylvania, 16148, United States

Location

GSK Investigational Site

Barnwell, South Carolina, 29812, United States

Location

GSK Investigational Site

Clarksville, Tennessee, 37043, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2C8, Canada

Location

GSK Investigational Site

Surrey, British Columbia, V3R 8P8, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

GSK Investigational Site

Mount Pearl, Newfoundland and Labrador, A1N 5B6, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8L 5G8, Canada

Location

GSK Investigational Site

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

GSK Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

GSK Investigational Site

Alcalá de Guadaira, 41500, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28223, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

Related Publications (1)

• Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, McNeil S, Reisinger KS, Aggarwal N, Huang LM, Peng CT, Garcia-Sicilia J, Salamanca de la Cueva I, Cabanas F, Trevino-Garza C, Rodriguez-Weber MA, de la O M, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013 Aug 15;208(4):544-53. doi: 10.1093/infdis/jit263. Epub 2013 Jul 11.

  PMID: 23847058 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 21, 2018
• Results First Posted: March 12, 2013

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (16); CA (9); ES (4); TW (2); ME (2)