Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

NCT01974895 | Completed Phase 2 Results

• 1 other identifier: 200806
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Conditions

Influenza

Keywords

Children; Immunogenicity; Fluzone®; 6 to 35 months of age; Seasonal influenza; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.

  A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.

  28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

Secondary Outcomes (12)

• Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.

  28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

• Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains

  On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)

• Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.

  At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)

• Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.

  28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

  During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination

Study Arms (2)

FluLaval Quadrivalent Group

EXPERIMENTAL

Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.

Biological: FluLaval® Quadrivalent

Fluzone Group

ACTIVE COMPARATOR

Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.

Biological: Fluzone®

Interventions

FluLaval® Quadrivalent BIOLOGICAL

1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.

Also known as: GSK2282512A

FluLaval Quadrivalent Group

Fluzone® BIOLOGICAL

1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.

Fluzone Group

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
• Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

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 study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
• Child in care.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• History of Guillain-Barré syndrome within six 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.
• Acute disease and/or fever at the time of enrollment.
• Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Sacramento, California, 95822, United States

Location

GSK Investigational Site

West Covina, California, 91790, United States

Location

GSK Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

GSK Investigational Site

Fall River, Massachusetts, 02721, United States

Location

GSK Investigational Site

Woburn, Massachusetts, 01801, United States

Location

GSK Investigational Site

Stevensville, Michigan, 49127, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, 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

Cheraw, South Carolina, 29520, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

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

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 4, 2013
• Study Start: October 23, 2013
• Primary Completion: February 27, 2014
• Study Completion: July 3, 2014
• Last Updated: September 7, 2018
• Results First Posted: April 13, 2015

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (12)