InfluenzaPhase 3NCT00449670
Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
A Phase 3 study testing H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) and H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain) in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Vaccines
- What is being tested?
- H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) and H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 24 Mar 2007to 10 Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Singapore2 sites
GSK Investigational Site
Singapore, 529889
GSK Investigational Site
Singapore, 688846
Taiwan2 sites
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 112
About this study
Official title: Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years
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.
Read the detailed description
The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Influenza, Influenza Vaccines
- Being tested
- H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
- Keywords
- Influenza, Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)Biological
Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)Biological
Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.
H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)Biological
Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.
| Study group | Role | What they receive |
|---|---|---|
| H5N1 Adjuvanted Group | Experimental | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). Receives: Biological: H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain) |
| H5N1 Un-adjuvanted Group | Active comparator | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. Receives: Biological: H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Before vaccination (Day 0)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Within 21 days following 2-dose primary vaccination (at Day 42)
Secondary outcomes (39)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Within 21 days following the first primary vaccination dose (Day 21)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28.
Measured: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
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
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Month 12
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 21 (D21) and at Day 42 (D42)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
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
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)
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
Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 12
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease
Seroconversion was defined as: antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Within 21 days following 2-dose primary vaccination at Day 42
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6
Seroconversion defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-booster antibody titer.
Measured: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 21, at Day 42, at Month 6 and at Month 12
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Measured: At Day 0, Day 21, Day 42, Month 6 and Month 12
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
The analyzed cytokines were CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
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
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: At Month 6 and Month 12
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
The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.
Measured: At Month 6 and at Month 12
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6
This group consists of the remaining subjects from the GSK1562902A Pooled Group who received a single dose of H5N1 vaccine at Month 12 or 36.
Measured: From Month 6 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study start24 Mar 2007
- Primary completion12 Jul 2007
- Study completion10 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449670
- Sponsor's protocol ID
- 109630
- Other IDs
- 109873
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2007
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Drame M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine. 2009 Dec 9;27(52):7428-35. doi: 10.1016/j.vaccine.2009.07.102. Epub 2009 Aug 13.
PubMed 19683087Chu DW, Kwong AS, Tsui WW, Wang JH, Ngai CK, Wan PK, Ong G, Tang HW, Roman F, Dram M, Bock HL. Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong. Hong Kong Med J. 2011 Feb;17(1):39-46.
PubMed 21282825Hwang SJ, Chang SC, Yu CJ, Chan YJ, Chen TJ, Hsieh SL, Lai HY, Lin MH, Liu JY, Ong G, Roman F, Drame M, Bock HL, Yang PC. Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J Formos Med Assoc. 2011 Dec;110(12):780-6. doi: 10.1016/j.jfma.2011.11.009. Epub 2011 Dec 23.
PubMed 22248833Thongcharoen P, Auewarakul P, Hutagalung Y, Ong G, Gillard P, Drame M, Bock HL. Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai. 2011 Aug;94(8):916-26.
PubMed 21863672Gillard P, Chu DW, Hwang SJ, Yang PC, Thongcharoen P, Lim FS, Drame M, Walravens K, Roman F. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 2014 Mar 15;14:142. doi: 10.1186/1471-2334-14-142.
PubMed 24628789
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years
- ClinicalTrials.gov ID
- NCT00449670
- Acronym / sponsor ID
- 109630
- Conditions
- Influenza, Influenza Vaccines
- Keywords
- Influenza, Influenza Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2007 (actual)
- Primary completion
- 12 Jul 2007 (actual)
- Study completion
- 10 Jun 2008 (actual)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H5N1 Adjuvanted Group | Experimental | Biological: H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). |
| H5N1 Un-adjuvanted Group | Active comparator | Biological: H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), Biological: H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21. | Biological | H5N1 Adjuvanted Group |
| H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21. | Biological | H5N1 Un-adjuvanted Group |
| H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005. | Biological | H5N1 Adjuvanted Group, H5N1 Un-adjuvanted Group |
Primary outcome
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before vaccination (Day 0)
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Within 21 days following 2-dose primary vaccination (at Day 42)
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
39 secondary outcomes
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Within 21 days following the first primary vaccination dose (Day 21)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
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
Time frame: At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6
Time frame: At Month 12
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 21 (D21) and at Day 42 (D42)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
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
Time frame: Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)
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
Time frame: At Month 12
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease
Time frame: Within 21 days following 2-dose primary vaccination at Day 42
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase
Time frame: Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6
Time frame: At Day 21, Day 42, Month 6 and Month 12 following primary vaccination
Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)
Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Time frame: At Day 21, at Day 42, at Month 6 and at Month 12
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
Time frame: Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6
Time frame: At Day 0, Day 21, Day 42, Month 6 and Month 12
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
Time frame: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
Time frame: Within 21 days of each primary vaccine dose: at Day 21 and at Day 42
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation
Time frame: Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)
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
Time frame: At Month 6 and Month 12
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
Time frame: At Month 6 and at Month 12
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase
Time frame: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase
Time frame: During the 7-days (Days 0-6) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the primary phase (from Day 0 to Month 6)
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the booster phase (from Month 6 to Month 12)
Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6
Time frame: From Month 6 to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19683087Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Drame M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine. 2009 Dec 9;27(52):7428-35. doi: 10.1016/j.vaccine.2009.07.102. Epub 2009 Aug 13.
- Background: PubMed 21282825Chu DW, Kwong AS, Tsui WW, Wang JH, Ngai CK, Wan PK, Ong G, Tang HW, Roman F, Dram M, Bock HL. Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong. Hong Kong Med J. 2011 Feb;17(1):39-46.
- Background: PubMed 22248833Hwang SJ, Chang SC, Yu CJ, Chan YJ, Chen TJ, Hsieh SL, Lai HY, Lin MH, Liu JY, Ong G, Roman F, Drame M, Bock HL, Yang PC. Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J Formos Med Assoc. 2011 Dec;110(12):780-6. doi: 10.1016/j.jfma.2011.11.009. Epub 2011 Dec 23.
- Background: PubMed 21863672Thongcharoen P, Auewarakul P, Hutagalung Y, Ong G, Gillard P, Drame M, Bock HL. Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai. 2011 Aug;94(8):916-26.
- Background: PubMed 24628789Gillard P, Chu DW, Hwang SJ, Yang PC, Thongcharoen P, Lim FS, Drame M, Walravens K, Roman F. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 2014 Mar 15;14:142. doi: 10.1186/1471-2334-14-142.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) and H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain) in people with Influenza and Influenza Vaccines, run by GlaxoSmithKline at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Singapore, Taiwan, Hong Kong, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease (time frame: Before vaccination (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449670, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.