InfluenzaPhase 2NCT00976820
Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
A Phase 2 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 30 sites in 2 countries.
Trial summary
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age. This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. Read more about this study
- Who is it for?
- Ages 6 months to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK2340274A and GSK2340273A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 20 Oct 2009to 21 Mar 2011
- Phase
- Phase 2
- 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 6 months to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Safety laboratory test results within the parameters specified in the protocol.
- Parent/ LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that their parent(s)/ LAR can and will comply with the requirements of the protocol.
- Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.
Who cannot join
- Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
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- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Administration of any licensed vaccine within 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.
- Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Child in care.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States17 sites
GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Conway, Arkansas, 72034
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Sacramento, California, 95816
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Wichita, Kansas, 67205
Canada13 sites
GSK Investigational Site
Brampton, Ontario, L6T 0G1
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Québec, Quebec, G1V 4T3
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
GSK Investigational Site
Toronto, Ontario, M5G 1N8
GSK Investigational Site
Toronto, Ontario, M9V 4B4
GSK Investigational Site
Winnipeg, Manitoba, R3A 1M3
About this study
Official title: A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.
This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
Read the detailed description
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
- Conditions
- Influenza
- Being tested
- GSK2340274A, GSK2340273A
- Keywords
- influenza infection, Influenza Vaccines, GSK Bio's influenza vaccine GSK2340273A, GSK Bio's influenza vaccine GSK2340274A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2340274ABiological
Two intramuscular injections
GSK2340273ABiological
Two intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Arepanrix/F1 Group | Experimental | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Receives: Biological: GSK2340274A |
| Arepanrix/F2 Group | Experimental | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Receives: Biological: GSK2340274A |
| GSK2340273A/F1 Group | Experimental | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Receives: Biological: GSK2340273A |
| GSK2340273A/F2 Group | Experimental | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). Receives: Biological: GSK2340273A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 21
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 42
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 42
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 21
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 42
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 42
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 21
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 42
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 42
Secondary outcomes (57)
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - Second Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies - Second Analysis
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Measured: At Day 0 (PRE) and at Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 182
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: At Day 182
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Measured: At Day 0 (PRE) and at Day 182
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 182
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Measured: At Day 0 (PRE) and at Day 21
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Measured: At Day 0 (PRE) and at Day 42
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Measured: At Day 0 (PRE) and at Day 42
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Measured: At Day 0 (PRE) and at Day 21
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.
Measured: At Day 0 (PRE) and at Day 42
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities
Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 182
Number of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 182
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
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: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
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: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis
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: Within 41 days (Days 0-40) post vaccination
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: Within 84 days (Days 0-83) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Within 41 days (Days 0-40) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Within 182 days (Days 0-181) post vaccination
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Throughout the entire study period (Day 0 - Day 385)
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Within 21 days (Days 0-20) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Within 42 days (Days 0-41) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Within 42 days (Days 0-41) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Within 182 days (Days 0-181) post vaccination
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Throughout the entire study period (Day 0 - Day 385)
Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis
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: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Serious Adverse Events (SAEs) - First Analysis
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: Within 42 days (Days 0-41) post vaccination
Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis
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: Within 42 days (Day 0-41) post vaccination
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: Within 182 days (Days 0-181) post vaccination
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: Throughout the entire study period (Day 0 - Day 385)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study start20 Oct 2009
- Primary completion21 Mar 2011
- Study completion21 Mar 2011
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 (1)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 323 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
- NCT00976820
- Sponsor's protocol ID
- 113482
- Status last verified
- Jul 2017
- First submitted
- 11 Sep 2009
- Last updated
- 12 Dec 2017
- 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
Langley JM, Reich D, Aggarwal N, Connor D, Lebel MH, Gupta A, Garfield H, Li P, Madan A, Vaughn DW. Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to <9 years of age: safety and immunogenicity. Pediatr Infect Dis J. 2012 Aug;31(8):848-58. doi: 10.1097/INF.0b013e31825e6cd6.
PubMed 22801094
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age
- ClinicalTrials.gov ID
- NCT00976820
- Acronym / sponsor ID
- 113482
- Conditions
- Influenza
- Keywords
- influenza infection, Influenza Vaccines, GSK Bio's influenza vaccine GSK2340273A, GSK Bio's influenza vaccine GSK2340274A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2009 (actual)
- Primary completion
- 21 Mar 2011 (actual)
- Study completion
- 21 Mar 2011 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.
This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
Detailed description
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arepanrix/F1 Group | Experimental | Biological: GSK2340274ASubjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
| Arepanrix/F2 Group | Experimental | Biological: GSK2340274ASubjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
| GSK2340273A/F1 Group | Experimental | Biological: GSK2340273ASubjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
| GSK2340273A/F2 Group | Experimental | Biological: GSK2340273ASubjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age). |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Safety laboratory test results within the parameters specified in the protocol.
- Parent/ LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (14 listed)
- Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
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 |
|---|---|---|
| GSK2340274ATwo intramuscular injections | Biological | Arepanrix/F1 Group, Arepanrix/F2 Group |
| GSK2340273ATwo intramuscular injections | Biological | GSK2340273A/F1 Group, GSK2340273A/F2 Group |
Primary outcome
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Time frame: At Day 21
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 21
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 21
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 42
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 42
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
57 secondary outcomes
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for HI Antibodies - First Analysis
Time frame: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Time frame: At Day 0 (PRE) and at Day 42
Number of Seropositive Subjects for HI Antibodies
Time frame: At Day 0 (PRE) and at Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 0 (PRE) and at Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Time frame: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Time frame: At Day 0 (PRE) and at Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 182
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
Time frame: At Day 182
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 182
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
Time frame: At Day 182
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 21
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 21
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 42
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Time frame: At Day 0 (PRE) and at Day 42
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Time frame: At Day 0 (PRE) and at Day 21
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Time frame: At Day 0 (PRE) and at Day 42
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
Time frame: At Day 0 (PRE), at Day 7 and at Day 21
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
Time frame: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42
Number of Subjects With Haematological Laboratory Abnormalities
Time frame: At Day 182
Number of Subjects With Biochemical Laboratory Abnormalities
Time frame: At Day 182
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
Time frame: Within 21 days (Days 0-20) post vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
Time frame: Within 42 days (Days 0-41) post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22801094Langley JM, Reich D, Aggarwal N, Connor D, Lebel MH, Gupta A, Garfield H, Li P, Madan A, Vaughn DW. Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to <9 years of age: safety and immunogenicity. Pediatr Infect Dis J. 2012 Aug;31(8):848-58. doi: 10.1097/INF.0b013e31825e6cd6.
- 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
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 30 sites in 2 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 7 inclusion and 14 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Dec 2017). 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?
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis (time frame: At Day 21). The study lists 20 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 NCT00976820, which also lists 1 linked publication.
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 12 Dec 2017.