Phase 3
N=844
Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00652743 ↗Enrolled (actual)
844
Serious AEs
6.5%
Results posted
Aug 2018
Primary outcome: Primary: Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value — 178 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pandemic influenza vaccine GSK1562902A (Biological)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value |
178 | — |
| PRIMARY Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 |
340.3 | — |
| PRIMARY Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value |
379 | — |
| PRIMARY Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 |
877.5 | — |
| PRIMARY Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 |
169 | — |
| PRIMARY Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 |
378 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 |
55.3 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 |
123.8 | — |
| PRIMARY Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease |
178 | — |
| PRIMARY Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease |
379 | — |
| SECONDARY Number of Seropositive Subjects for H5N1 HI Antibodies |
127; 143; 0; 125; 133; 365 | — |
| SECONDARY Number of Seropositive Subjects for H5N1 HI Antibodies |
127; 143; 0; 125; 133; 365 | — |
| SECONDARY Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 |
149; 0; 48; 70; 52; 69 | — |
| SECONDARY Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies |
75; 6; 14; 61; 43; 58 | — |
| SECONDARY Booster Vaccine Response for H5N1 HI Antibodies |
91; 115; 0; 59; 89; 0 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies |
3.8; 8.6; 2.8; 6.0; 3.0; 6.1 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies |
3.8; 8.6; 2.8; 6.0; 3.0; 6.1 | — |
| SECONDARY Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies |
104; 126; 0; 70; 101; 0 | — |
| SECONDARY Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies |
104; 126; 0; 70; 101; 0 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies |
179.7; 2702.0; 2363.2; 1154.3; 134.0; 58.5 | — |
| SECONDARY Booster Vaccine Response for Neutralizing Antibodies |
4; 0; 0; 0; 34; 0 | — |
| SECONDARY Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value |
160; 0; 0; 74; 135; 0 | — |
| SECONDARY Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off |
162; 0; 0; 75; 162; 0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
2; 1; 0; 0; 17; 23 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptom |
48; 99; 6; 7; 45; 95 | — |
| SECONDARY Number of Subjects With Adverse Events of Specific Interest (AESIs) |
0; 0; 1 | — |
| SECONDARY Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) |
1119.00; 1862.00; 3109.50; 2620.00; 1599.00; 1443.00 | — |
| SECONDARY Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) |
1615.50; 2133.00; 3047.00; 2410.00; 1889.00; 1849.50 | — |
| SECONDARY Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) |
34.50; 1.00; 14.00; 1.00; 26.00; 44.00 | — |
| SECONDARY Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) |
33.00; 69.00; 1.00; 26.00; 24.00; 24.00 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
44; 85; 6; 9; 22; 34 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
14; 13; 28; 2; 3; 4 | — |
Summary
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
Eligibility Criteria
Inclusion Criteria
- Subjects who completed participation in primary phase of this study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or be post-menopausal; if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria
- Administration of any licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of chronic alcohol consumption and/or drug abuse.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first visit or planned use during the study.
- Pregnant or lactating women.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first visit, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Data sourced from ClinicalTrials.gov (NCT00652743). 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.