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Phase 3 N=5,168 Randomized Double-blind Prevention

A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Influenza

Enrolled (actual)
5,168
Serious AEs
1.2%
Results posted
Apr 2013
Primary outcome: Primary: Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. — 58; 128 subjects

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
FluLaval® Quadrivalent (Biological); Havrix™ (Biological)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.
58; 128
SECONDARY
Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.
14; 52
SECONDARY
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.
31; 56
SECONDARY
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.
50; 112
SECONDARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
15.3; 16.1; 318.8; 16.1; 24.3; 28.6
SECONDARY
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
438; 1; 385; 2; 425; 3
SECONDARY
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
151; 37; 451; 39; 205; 63
SECONDARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
20.8; 1.0; 10.9; 1.0; 17.5; 1.1
SECONDARY
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains
15.5; 16.5; 138.6; 23.2; 24.6; 29.1
SECONDARY
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.
349; 9; 290; 10; 323; 12
SECONDARY
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.
148; 36; 383; 49; 204; 60
SECONDARY
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.
8.9; 1.4; 5.5; 1.5; 8.0; 1.3
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
1215; 888; 36; 20; 17; 5
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.
100; 93; 5; 4; 57; 61
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.
188; 145; 1; 6; 101; 78
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
843; 855; 25; 20; 30; 37
SECONDARY
Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).
792; 749; 6; 13
SECONDARY
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
0; 1; 0; 0
SECONDARY
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
36; 24; 1; 0

Summary

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.

Eligibility Criteria

Inclusion Criteria

  • 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 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
  • Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
  • Written 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.
  • Access to a consistent means of telephone contact

Exclusion Criteria

  • Child in care.
  • Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
  • Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at >=12 months of age.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 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-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; 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.
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01218308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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