Phase 3
Completed N=1,206
Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
Influenza · Influenza Vaccines
Source: ClinicalTrials.gov NCT00449670 ↗
Enrolled (actual)
1,206
Serious AEs
2.5%
Results posted
Apr 2020
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease — 5.6; 5.5; 5.6; 5.4 Titers
◆ Published Evidence
Established
23citations · ~2 / year
Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults.
Summary
The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.
Linked Publications (2)
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Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults.
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Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
19.4; 5.8; 395.3; 31.0; 78; 76.1 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
19.4; 5.8; 395.3; 31.0; 78; 76.1 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
19.4; 5.8; 395.3; 31.0; 78; 76.1 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
19.4; 5.8; 395.3; 31.0; 78; 76.1 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
19.4; 5.8; 395.3; 31.0; 78; 76.1 | — |
| SECONDARY Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease |
17.8; 17.8; 18; 16.6; 17.7; 274.4 | — |
| SECONDARY Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease |
170.5; 29.4; 1660.1; 248.1; 447.1; 183.6 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 |
5.6; 23.3; 215.7; 18.5; 11.4; 5.1 | — |
| SECONDARY Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 |
215.5; 57.9 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease |
96; 2; 244; 110; 0; 174 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease |
96; 2; 244; 110; 0; 174 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase |
93; 57; 140; 67 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase |
93; 57; 140; 67 | — |
| SECONDARY Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease |
64; 70; 64; 68; 23; 61 | — |
| SECONDARY Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase |
140; 36; 0; 41; 165; 41 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6 |
293; 620; 228; 108; 18; 328 | — |
| SECONDARY Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 |
20; 15 | — |
| SECONDARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.6; 1; 74; 5.3; 13.4; 1.3 | — |
| SECONDARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.6; 1; 74; 5.3; 13.4; 1.3 | — |
| SECONDARY Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.7; 2.5; 7.2; 2.9 | — |
| SECONDARY Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
3.7; 2.5; 7.2; 2.9 | — |
| SECONDARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 |
4.2; 38.8; 3.3; 2; 1.2; 4.9 | — |
| SECONDARY Number of Subjects Seroprotected Against 2 Strains of Influenza Disease |
103; 4; 247; 121; 0; 180 | — |
| SECONDARY Number of Subjects Seroprotected Against 2 Strains of Influenza Disease |
103; 4; 247; 121; 0; 180 | — |
| SECONDARY Number of Seroprotected Subjects Against 2 Strains of Influenza Disease |
103; 4; 242; 120; 0; 177 | — |
| SECONDARY Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6 |
11; 307; 623; 247; 131; 1 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation |
1773.0; 681.00; 7049.60; 3898.00; 4472.75; 3197.29 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation |
55.00; 306.00; 50.00; 62.60; 257.63; 50.86 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation |
1773.0; 681.00; 7049.60; 3898.00; 4472.75; 3197.29 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation |
55.00; 306.00; 50.00; 62.60; 257.63; 50.86 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 |
2529.54; 2098.17; 2407.31; 2004.27; 1387.38; 1184.07 | — |
| SECONDARY Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6 |
82.69; 106.13; 9.62; 4.53; 67.23; 102.93 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
8; 0; 0; 0; 54; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
118; 16; 5; 0; 109; 14 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase |
2; 1; 0; 0; 21; 14 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase |
57; 33; 4; 1; 57; 32 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
65; 54 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
65; 54 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs). |
3; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs). |
3; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6 |
15 | — |
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 between, and including, 18 and 60 years of age at the time of the first vaccination.
- 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, 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 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 during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).
- Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine.
- Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines.
- 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 3 months preceding the first administration of the candidate vaccine or during the study.
- 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 vaccination, 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 (NCT00449670) and the linked publication. 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.