Phase 3
Completed N=470
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Source: ClinicalTrials.gov NCT01702454 ↗Enrolled (actual)
470
Serious AEs
3.2%
Results posted
Jul 2014
Primary outcomePrimary: Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine — 43.1; 14.5; 445.6; 45.8 Titer
Summary
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine |
43.1; 14.5; 445.6; 45.8; 12.3; 16.4 | — |
| PRIMARY Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine |
189; 64; 220; 137; 131; 79 | — |
| PRIMARY Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
160; 54; 173; 49; 162; 66 | — |
| PRIMARY Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
10.3; 3.2; 10.9; 2.9; 6.7; 4.6 | — |
| PRIMARY Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
89; 61; 217; 72; 37; 74 | — |
| PRIMARY Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
44.0; 14.3; 442.3; 42.7; 11.0; 11.9 | — |
| PRIMARY Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine |
178; 54; 209; 113; 120; 52 | — |
| PRIMARY Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
10.0; 3.1; 11.2; 2.4; 6.9; 4.5 | — |
| PRIMARY Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
87; 51; 206; 59; 29; 48 | — |
| SECONDARY Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
32; 119; 4; 66; 178; 54 | — |
| SECONDARY Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine |
138.2; 48.3; 1500.9; 139.4; 66.5; 82.8 | — |
| SECONDARY Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine |
34.8; 23.5; 287.1; 38.3; 35.0; 45.9 | — |
| SECONDARY Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains. |
74; 36; 72; 48; 78; 24 | — |
| SECONDARY MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
10.0; 3.1; 6.2; 3.4; 5.1; 2.2 | — |
| SECONDARY Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains. |
75; 31; 75; 31; 79; 24 | — |
| SECONDARY MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
8.3; 1.8; 5.2; 1.9; 8.8; 2.7 | — |
| SECONDARY Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine. |
141.4; 47.3; 1461.3; 138.4; 60.0; 59.6 | — |
| SECONDARY Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains |
67; 28; 66; 31; 74; 21 | — |
| SECONDARY Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains. |
70; 23; 70; 22; 74; 20 | — |
| SECONDARY MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine |
8.1; 1.7; 5.0; 1.8; 5.2; 1.9 | — |
| SECONDARY Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata. |
76.8; 29.0; 1112.0; 53.0; 240.0; 78.8 | — |
| SECONDARY Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata |
21.6; 15.8; 246.3; 22.9; 55.5; 36.1 | — |
| SECONDARY Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata |
39; 12; 35; 24; 36; 19 | — |
| SECONDARY MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata |
13.1; 2.0; 8.7; 4.7; 6.1; 3.4 | — |
| SECONDARY Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata. |
43; 11; 32; 20; 36; 8 | — |
| SECONDARY MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata. |
11.4; 1.5; 6.0; 2.1; 4.6; 1.7 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
96; 61; 2; 1; 82; 48 | — |
| SECONDARY Duration of Solicted Symptoms |
1.0; 1.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. |
54; 44; 5; 1; 36; 28 | — |
| SECONDARY Number of Subjects Reporting AEs With Medically Attended Visits (MAV) |
149; 130; 5; 8; 0; 1 | — |
| SECONDARY Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs. |
66; 66; 6; 7; 5; 3 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
7; 8; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
- 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
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
- Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
- Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. 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.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Any contraindication to intramuscular injection.
- Acute disease and/or fever at the time of enrollment:
- Fever is defined as temperature ≥ 37.5°C by any route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Data sourced from ClinicalTrials.gov (NCT01702454). 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.