Phase 2
Completed N=314
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
Source: ClinicalTrials.gov NCT01974895 ↗Enrolled (actual)
314
Serious AEs
2.9%
Results posted
Apr 2015
Primary outcomePrimary: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine. — 115; NA; 103; NA Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine. |
115; NA; 103; NA; 123; NA | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains. |
NA; 98; NA; 94; NA; 115 | — |
| SECONDARY Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains |
10.3; 10.0; 141.3; 90.8; 11.1; 11.5 | — |
| SECONDARY Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains. |
25; 22; 125; 111; 29; 25 | — |
| SECONDARY Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains. |
13.73; 9.11; 9.09; 7.53; 14.59; 11.36 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. |
48; 48; 4; 1; 2; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. |
60; 56; 6; 3; 52; 48 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Fever |
7; 8; 0; 1; 7; 7 | — |
| SECONDARY Duration of Solicited Local and General Symptoms |
1.0; 1.0; 1.0; 1.0; 1.5; 0.0 | — |
| SECONDARY Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs) |
77; 89; 2; 4 | — |
| SECONDARY Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
77; 75; 12; 12; 11; 7 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
5; 4; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01974895). 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. Informational only — not medical advice.