Phase 3
N=5,168
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01218308 ↗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
| Outcome | Result | p-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.
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.