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

NCT01711736 | Completed Phase 3 Results

• 2 other identifiers: 1169262013-003155-38
• Study Type: interventional
• Target: 606
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Conditions

Influenza

Keywords

Immunogenicity; Children; Safety; Seasonal influenza; Fluarix

Outcome Measures

Primary Outcomes (4)

• Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A 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/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.

  At Day 28 for primed subjects and at Day 56 for unprimed subjects

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

  Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \>100mm.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).

  Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects Reporting Any, Grade 3 and Related Fever

  Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.

  During the 7-day (Days 0-6) post-vaccination period

Secondary Outcomes (9)

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

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

• Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine

  At Day 28 for primed subjects and at Day 56 for unprimed subjects

• Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (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 Haemagglutination Inhibition (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, Grade 3 and Related Fever

  During the 4-day (Days 0-3) post-vaccination period

Study Arms (2)

GSK2282512A Group

EXPERIMENTAL

Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

Biological: Quadrivalent influenza GSK2282512A vaccine

Fluarix Group

ACTIVE COMPARATOR

Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

Biological: Fluarix

Interventions

Quadrivalent influenza GSK2282512A vaccine BIOLOGICAL

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

GSK2282512A Group

Fluarix BIOLOGICAL

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Fluarix Group

Eligibility Criteria

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

You may qualify if:

• Subject's 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 the 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.
• 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
• 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 enrolment.
• 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 (8)

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

Mirabel, Quebec, J7J 2K8, Canada

Location

GSK Investigational Site

Québec, Quebec, G1E 7G9, Canada

Location

GSK Investigational Site

Santo Domingo, Distrito Nacional, 11201, Dominican Republic

Location

GSK Investigational Site

San Pedro Sula, 21102, Honduras

Location

Related Publications (2)

• Bekkat-Berkani R, Ray R, Jain VK, Chandrasekaran V, Innis BL. Evidence update: GlaxoSmithKline's inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 2016;15(2):201-14. doi: 10.1586/14760584.2016.1113878. Epub 2015 Dec 5.

  PMID: 26641539 BACKGROUND

• Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.

  PMID: 26336604 BACKGROUND

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

fluarix

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: October 18, 2012
• First Posted: October 22, 2012
• Study Start: November 1, 2012
• Primary Completion: February 21, 2013
• Study Completion: June 19, 2013
• Last Updated: November 1, 2021
• Results First Posted: April 3, 2014

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

DO (1); HO (1); CA (6)