NCT01439360CompletedPhase 3
An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children
GlaxoSmithKline103 sites in 9 countries12,046 target enrollmentStarted: October 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 12,046
- Locations
- 103
- Primary Endpoint
- Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 35 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) 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 first vaccination; children are eligible regardless of history of influenza vaccination.
- •Written informed consent obtained from the parent(s) /LAR(s) of the subject.
- •Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Exclusion Criteria
- •Participation in a previous FLU-D-QIV-004 study (115345) cohort.
- •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 influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
- •Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
- •Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
- •Any contraindication to intramuscular injection.
- •Acute disease and/or fever at the time of enrolment.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
- •Additional criteria for children ≥ 12 months of age:
- •Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
- •* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
- •Any history of hepatitis A or varicella diseases.
- •Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
- •Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
Arms & Interventions
D-QIV
Experimental
Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
Intervention: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Intervention: Varivax/ProVarivax (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Intervention: Varilrix (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Intervention: Prevenar 13 (Biological)
Control
Active Comparator
In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Intervention: Havrix Junior (Biological)
Outcomes
Primary Outcomes
Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Time Frame: During the surveillance period (approximately 6 to 8 months)
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
Time Frame: During the surveillance period (approximately 6 to 8 months)
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Secondary Outcomes
- Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.(At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.(During the surveillance period (approximately 6 to 8 months))
- Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 0 and Day 28/56)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).(During the entire study period (approximately 6- 8 months per subject))
- Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.(At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months))
- Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)(At Days 0 and 28/56)
- Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 28/56 (POST))
- Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).(At Day 28/56 (POST))
- Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)(At Day 0 and Day 28/56)
- Duration of Solicited Local Symptoms(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Duration of Solicited General Symptoms(During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 28-day (Days 0-27) post-vaccination period)
- Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)(During the entire study period (approximately 6- 8 months per subject))
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).(During the entire study period (approximately 6- 8 months per subject))
Investigators
Study Sites (103)
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