Phase 2
N=405
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00502593 ↗Enrolled (actual)
405
Serious AEs
1.2%
Results posted
Jun 2014
Primary outcome: Primary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease — NA; NA; NA; NA Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pandemic Influenza Vaccine (GSK1562902A) (Biological); Fluarix™ (Biological)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
14.9; NA; 13.2; NA; 52.2; 6.8 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease |
18; 0; 8; 0; 30; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease |
18; 0; 8; 0; 30; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease |
18; 0; 8; 0; 30; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease |
18; 0; 8; 0; 30; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease |
18; 0; 8; 0; 30; 1 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.0; NA; 2.5; NA; 10.4; 1.4 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.0; NA; 2.5; NA; 10.4; 1.4 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.0; NA; 2.5; NA; 10.4; 1.4 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.0; NA; 2.5; NA; 10.4; 1.4 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.0; NA; 2.5; NA; 10.4; 1.4 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease |
18; 0; 9; 0; 30; 1 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms |
4; 0; 4; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms |
4; 0; 4; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
6; 3; 7; 0; 9; 2 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
6; 3; 7; 0; 9; 2 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms |
4; 0; 4; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events |
29; 12; 10; 5; 28; 9 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C |
0; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C |
0; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C |
0; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C |
0; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C |
0; 0; 0; 0; 3; 0 | — |
| PRIMARY Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C |
0; 0; 0; 0; 2; 0 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A |
0; 0; 0; 0; 50; 18 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A |
0; 0; 0; 0; 46; 18 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A |
0; 0; 0; 0; 50; 18 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A |
0; 0; 0; 0; 52; 18 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A |
0; 0; 0; 0; 51; 17 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A |
0; 0; 0; 0; 41; 12 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B |
0; 0; 0; 0; 50; 16 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B |
0; 0; 0; 0; 48; 15 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B |
0; 0; 0; 0; 51; 16 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B |
0; 0; 0; 0; 46; 14 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B |
0; 0; 0; 0; 47; 14 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C |
0; 1; 0; 0; 42; 11 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C |
0; 0; 0; 0; 43; 15 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B |
0; 0; 0; 0; 49; 16 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C |
0; 0; 0; 0; 41; 12 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C |
0; 0; 0; 0; 43; 13 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C |
0; 0; 0; 0; 44; 15 | — |
| PRIMARY Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C |
0; 0; 0; 0; 36; 12 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease |
37.3; 35.5; 25.6; 27.1; 473.8; 111.3 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease |
37.3; 35.5; 25.6; 27.1; 473.8; 111.3 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease |
37.3; 35.5; 25.6; 27.1; 473.8; 111.3 | — |
| SECONDARY Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies |
29; 7; 23; 3; 37; 6 | — |
| SECONDARY Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies |
29; 7; 23; 3; 37; 6 | — |
| SECONDARY Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies |
29; 7; 23; 3; 37; 6 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease |
781.2; 208.5; 756.1; 482.3; 238.9; 35.4 | — |
| SECONDARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response |
41; 9; 38; 13; 37; 3 | — |
| SECONDARY Number of Subjects With Adverse Events of Specific Interest (AESIs) |
1; 0; 0; 1; 1; 1 | — |
Summary
The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Children aged between and including 3 and 9 years of age at the time of first vaccination.
- Written informed consent obtained from the parent(s) or guardian of the subject.
- Healthy children as established by medical history and clinical examination before entering the study.
- Subjects who are likely to reside in the vicinity of the study center for the duration of the study.
Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
- Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
- Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
- Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines used in this study.
- History of any neurological disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study or planned during the study.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study
Data sourced from ClinicalTrials.gov (NCT00502593). 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.