Phase 3
Completed N=601
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age
Source: ClinicalTrials.gov NCT01711736 ↗Enrolled (actual)
601
Serious AEs
2.8%
Results posted
Apr 2014
Primary outcomePrimary: Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. — 244; 205; 224; 210 subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. |
244; 205; 224; 210 | — |
| PRIMARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. |
95; 91; 7; 3; 6; 6 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). |
93; 88; 9; 9; 79; 80 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Fever |
46; 42; 16; 8; 39; 38 | — |
| SECONDARY Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains |
9.6; 9.8; 157.1; 61.2; 17.4; 13.8 | — |
| SECONDARY Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine |
154; 160; 222; 28 | — |
| SECONDARY Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
46; 47; 254; 169; 93; 74 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. |
16.4; 6.2; 9.1; 7.5; 14.8; 14.8 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Fever |
46; 42; 16; 8; 39; 38 | — |
| SECONDARY Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs) |
156; 156 | — |
| SECONDARY Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) |
0; 2; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
142; 165; 9; 5; 17; 13 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
9; 8; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01711736). 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.