Trial Outcomes & Findings for CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations (NCT NCT00943488)
NCT ID: NCT00943488
Last Updated: 2012-10-31
Results Overview
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
COMPLETED
PHASE2
408 participants
Day 0 prior to and Day 8-10 after first vaccination
2012-10-31
Participant Flow
Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 07AUG2009 and 21AUG2009
Participant milestones
| Measure |
H1N1 Vaccine 15 Mcg
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
204
|
|
Overall Study
COMPLETED
|
203
|
202
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
Baseline characteristics by cohort
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
102 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Age Continuous
|
57.9 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
204 participants
n=5 Participants
|
204 participants
n=7 Participants
|
408 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after first vaccinationPopulation: All participants receiving the first vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Pain
|
29 Participants
|
53 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Tenderness
|
62 Participants
|
95 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Swelling
|
23 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after second vaccinationPopulation: All participants receiving the second vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=201 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=201 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Pain
|
33 Participants
|
45 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Tenderness
|
60 Participants
|
91 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Swelling
|
11 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after first vaccinationPopulation: All participants receiving the first vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
Swelling
|
29 Participants
|
31 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
Redness
|
26 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after second vaccinationPopulation: All participants receiving the second vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=201 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=201 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
Swelling
|
10 Participants
|
16 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
Redness
|
22 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after first vaccinationPopulation: All participants receiving the first vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Feverishness
|
18 Participants
|
20 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Malaise
|
39 Participants
|
51 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Myalgia
|
27 Participants
|
28 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Headache
|
37 Participants
|
34 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Nausea
|
8 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after second vaccinationPopulation: All participants receiving the second vaccination are included in the safety ITT cohort
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=201 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=201 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Feverishness
|
10 Participants
|
23 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Malaise
|
28 Participants
|
36 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Myalgia
|
22 Participants
|
23 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Headache
|
35 Participants
|
33 Participants
|
|
Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Nausea
|
4 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after first vaccinationPopulation: All participants receiving the first vaccination are included in the safety ITT cohort
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Fever After the First Vaccination
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 0-7 after second vaccinationPopulation: All participants receiving the second vaccination are included in the safety ITT cohort
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=201 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=201 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Fever After the Second Vaccination
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 8-10 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=97 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 0
|
13 Participants
|
10 Participants
|
|
Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 8-10
|
78 Participants
|
81 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 8-10 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=105 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 0
|
16 Participants
|
18 Participants
|
|
Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 8-10
|
62 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: Day 21 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=96 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
|
82 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: Day 21 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=100 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=104 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
|
60 Participants
|
74 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 180 after last vaccinationPopulation: All participants receiving the first vaccination are included in the safety ITT cohort
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=204 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 8-10 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=97 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
|
71 Participants
|
75 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 8-10 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=105 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
|
50 Participants
|
58 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 21 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=102 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=96 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
|
77 Participants
|
78 Participants
|
PRIMARY outcome
Timeframe: Day 0 prior to and Day 21 after first vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=100 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=104 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
|
54 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to first vaccination and Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=99 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=93 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
|
77 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to first vaccination and Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=97 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=104 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
|
56 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.
Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=99 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=94 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
|
81 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Day 0 prior to first vaccination and Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=97 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=103 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
|
56 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=99 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=93 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
|
84 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=97 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=104 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
|
63 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.
Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=99 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=94 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
|
87 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.
Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Outcome measures
| Measure |
H1N1 Vaccine 15 Mcg
n=97 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=103 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
|
60 Participants
|
80 Participants
|
Adverse Events
H1N1 Vaccine 15 Mcg
H1N1 Vaccine 30 Mcg
Serious adverse events
| Measure |
H1N1 Vaccine 15 Mcg
n=204 participants at risk
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 participants at risk
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Infections and infestations
Cellullitis
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Chest discomfort
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Pneumonia
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Loss of consciousness
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.98%
2/204 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Vascular disorders
Aortic stenosis
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Chest pain
|
0.98%
2/204 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/204 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
0.49%
1/204 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Other adverse events
| Measure |
H1N1 Vaccine 15 Mcg
n=204 participants at risk
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=204 participants at risk
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
General disorders
Injection site haematoma
|
4.4%
9/204 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
8.3%
17/204 • Number of events 17 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
15/204 • Number of events 15 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
8.3%
17/204 • Number of events 17 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Feeling hot
|
13.2%
27/204 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
19.1%
39/204 • Number of events 43 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Malaise
|
26.0%
53/204 • Number of events 67 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
33.8%
69/204 • Number of events 87 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.1%
41/204 • Number of events 49 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
20.6%
42/204 • Number of events 51 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Nervous system disorders
Headache
|
28.4%
58/204 • Number of events 72 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
25.5%
52/204 • Number of events 67 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
11/204 • Number of events 12 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
10.8%
22/204 • Number of events 25 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site pain
|
24.0%
49/204 • Number of events 62 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
35.8%
73/204 • Number of events 98 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Tenderness
|
43.6%
89/204 • Number of events 122 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
58.3%
119/204 • Number of events 186 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site erythema
|
19.6%
40/204 • Number of events 48 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
20.1%
41/204 • Number of events 51 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site swelling (functional grading)
|
14.7%
30/204 • Number of events 34 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
16.7%
34/204 • Number of events 40 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
|
General disorders
Injection site swelling (measured)
|
17.2%
35/204 • Number of events 39 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
20.1%
41/204 • Number of events 47 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
|
Additional Information
Patricia Winokur, MD
Carver College of Medicine, University of Iowa
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60