Phase 2
Completed N=512
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
Influenza · Influenza Vaccines
Source: ClinicalTrials.gov NCT00430521 ↗
Enrolled (actual)
512
Serious AEs
3.5%
Results posted
Oct 2019
Primary outcomePrimary: Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value — 0; 0; 0; 0 Participants
Summary
The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value |
51; 41; 47; 41; 51; 43 | — |
| PRIMARY Geometric Mean Titers (GMTs) of H5N1 HI Antibodies |
303.4; 92.4; 392.9; 127.7; 434.7; 287.2 | — |
| PRIMARY Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
60.7; 18.5; 78.6; 25.5; 86.9; 54.2 | — |
| PRIMARY Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
51; 40; 46; 40; 51; 43 | — |
| PRIMARY Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
51; 40; 46; 40; 51; 43 | — |
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
1; 1; 2; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
8; 12; 11; 15; 13; 9 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
35; 23; 32; 31; 27; 24 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
4; 1; 0; 3; 1; 5 | — |
| PRIMARY Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease |
51; 39; 45; 39; 51; 42 | — |
| PRIMARY Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease |
55.3; 17.6; 45.6; 17.9; 35.4; 29.2 | — |
| SECONDARY GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12 |
5.0; 5.0; 5.0; 5.0; 6.8; 6.3 | — |
| SECONDARY Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 |
40; 37; 36; 34; 46; 39 | — |
| SECONDARY Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 |
1.4; 1.3; 1.2; 1.1; 5.9; 3.6 | — |
| SECONDARY Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 |
0; 0; 0; 0; 5; 3 | — |
| SECONDARY GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6 |
5.0; 5.0; 5.0; 5.0; 6.5; 5.6 | — |
| SECONDARY Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 |
0; 3; 0; 3; 15; 23 | — |
| SECONDARY Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6 |
1.1; 1.3; 1.1; 1.2; 4.1; 4.6 | — |
| SECONDARY Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12 |
38; 43; 34; 39; 41; 49 | — |
| SECONDARY Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 |
35.2; 16.8; 27.9; 18.7; 78.7; 23.6 | — |
| SECONDARY Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6 |
412.03; 467.30; 395.60; 469.25; 600.07; 807.14 | — |
| SECONDARY Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12 |
560.41; 529.20; 542.86; 771.60; 1296.63; 931.49 | — |
| SECONDARY GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6 |
15.7; 15.5; 15.4; 14.4; 39.8; 32.0 | — |
| SECONDARY GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12 |
15.8; 15.7; 15.1; 15.5; 43.5; 37.0 | — |
| SECONDARY GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 |
15.7; 15.3; 15.5; 14.4; 40.6; 31.8 | — |
| SECONDARY GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 |
15.9; 15.6; 15.4; 15.7; 45.1; 40.0 | — |
| SECONDARY Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 |
19; 13; 1; 4; 32; 28 | — |
| SECONDARY Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 |
19; 17; 1; 1; 35; 32 | — |
| SECONDARY Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 |
48; 41; 43; 41; 46; 41 | — |
| SECONDARY Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 |
39; 34; 32; 20; 44; 38 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- 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 be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria
- Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
- History of vaccination with investigational influenza pandemic vaccine.
- History of administration of an experimental/licensed vaccine
- Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
- 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, based on 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 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 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 (NCT00430521). 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.