Phase 2
N=385
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Influenza · Influenza Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00306995 ↗Enrolled (actual)
385
Serious AEs
0.8%
Results posted
Feb 2020
Primary outcome: Primary: Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) — 24.4; 15.6; 14.6; 9.8 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB218352_15 (Biological); SB218352_8 (Biological); SB218352_4 (Biological); SB218352_2 (Biological); SB218352_8AL (Biological); SB218352_4AL (Biological); SB218352_2AL (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) |
24.4; 15.6; 14.6; 9.8; 23.3; 18.8 | — |
| PRIMARY Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) |
49.5; 51.3; 51.1; 32.2; 71.0; 44.0 | — |
| PRIMARY Number of Seroconverted Subjects Against Influenza A Subtype H9N2 |
15; 18; 19; 13; 20; 15 | — |
| PRIMARY Number of Seroconverted Subjects Against Influenza A Subtype H9N2 |
15; 18; 19; 13; 20; 15 | — |
| PRIMARY Seroconversion Factor for Influenza A Subtype H9N2 |
5.4; 8.3; 7.9; 4.4; 10.5; 6.4 | — |
| PRIMARY Seroconversion Factor for Influenza A Subtype H9N2 |
5.4; 8.3; 7.9; 4.4; 10.5; 6.4 | — |
| PRIMARY Number of Seroprotected Subjects Against H9N2 |
18; 18; 21; 17; 22; 18 | — |
| PRIMARY Number of Seroprotected Subjects Against H9N2 |
18; 18; 21; 17; 22; 18 | — |
| PRIMARY Number of Subjects With Seroprotection Power Against H9N2 |
13; 17; 20; 15; 21; 18 | — |
| PRIMARY Number of Subjects With Seroprotection Power Against H9N2 |
13; 17; 20; 15; 21; 18 | — |
| PRIMARY Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) |
49.5; 51.3; 51.1; 32.2; 71.0; 44.0 | — |
| PRIMARY Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) |
49.5; 51.3; 51.1; 32.2; 71.0; 44.0 | — |
| PRIMARY Number of Seroconverted Subjects Against Influenza A Subtype H9N2 |
15; 18; 19; 13; 20; 15 | — |
| PRIMARY Number of Seroconverted Subjects Against Influenza A Subtype H9N2 |
15; 18; 19; 13; 20; 15 | — |
| PRIMARY Seroconversion Factor for Influenza A Subtype H9N2 |
5.4; 8.3; 7.9; 4.4; 10.5; 6.4 | — |
| PRIMARY Seroconversion Factor for Influenza A Subtype H9N2 |
5.4; 8.3; 7.9; 4.4; 10.5; 6.4 | — |
| PRIMARY Number of Seroprotected Subjects Against H9N2 |
18; 18; 21; 17; 22; 18 | — |
| PRIMARY Number of Seroprotected Subjects Against H9N2 |
18; 18; 21; 17; 22; 18 | — |
| PRIMARY Number of Subjects With Seroprotection Power Against H9N2 |
13; 17; 20; 15; 21; 18 | — |
| PRIMARY Number of Subjects With Seroprotection Power Against H9N2 |
13; 17; 20; 15; 21; 18 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
8; 3; 3; 6; 4; 4 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells |
557.00; 785.00; 782.00; 472.00; 738.00; 691.00 | — |
| SECONDARY Frequency of Antigen-specific CD4 T-cells |
414.00; 491.00; 524.00; 381.00; 509.00; 487.50 | — |
| SECONDARY Cytokine-positive CD4 T-cells Frequency |
295.00; 326.00; 219.00; 342.00; 434.50; 398.00 | — |
| SECONDARY Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells |
107.00; 62.00; 104.00; 83.50; 83.00; 83.00 | — |
| SECONDARY Frequency of Antigen-specific CD8 T-cells |
52.00; 20.00; 56.00; 34.50; 7.50; 25.00 | — |
| SECONDARY Cytokine-positive CD8 T-cells Frequency |
2.00; 0.00; 16.00; 0.00; 0.00; 4.00 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
6; 1; 5; 3; 9; 8 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
6; 1; 5; 3; 9; 8 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
2; 1; 1; 0; 0; 3 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
2; 1; 1; 0; 0; 3 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
2; 1; 1; 0; 0; 3 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
2; 1; 1; 0; 0; 3 | — |
| SECONDARY Number of Subjects With Unsolicited AEs |
2; 2; 3; 4; 1; 1 | — |
| SECONDARY Number of Subjects With SAEs |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any SAEs |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Antibody Persistence |
13; 9; 11; 6; 8; 10 | — |
| SECONDARY Seroconversion Factor (SCF) for Influenza A Subtype H9N2. |
2.9; 3.4; 3.7; 2.3; 3.2; 3.2 | — |
Summary
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
Eligibility Criteria
Inclusion criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- A male or female aged over 60 years at the time of vaccination.
- Written informed consent obtained from the subject.
Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Participation in an earlier study with a candidate pandemic H9N2 vaccine.
- Acute disease at the time of enrolment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Drug and/or alcohol dependency.
Data sourced from ClinicalTrials.gov (NCT00306995). 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.