Trial Outcomes & Findings for Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations (NCT NCT00943631)
NCT ID: NCT00943631
Last Updated: 2012-10-31
Results Overview
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.
COMPLETED
PHASE2
406 participants
Day 0 through Day 180 after last 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 and vaccinated between 07AUG2009 and 18AUG2009.
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
|
202
|
204
|
|
Overall Study
COMPLETED
|
198
|
202
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
Baseline characteristics by cohort
| Measure |
H1N1 Vaccine 15 Mcg
n=202 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=406 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
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
100 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Age Continuous
|
58.7 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 16.4 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=5 Participants
|
204 participants
n=7 Participants
|
406 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 180 after last vaccinationSerious 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=202 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 0-7 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. 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=202 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
|
36 Participants
|
34 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Tenderness
|
58 Participants
|
75 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Swelling
|
27 Participants
|
16 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. 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=192 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=197 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
|
27 Participants
|
27 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Tenderness
|
54 Participants
|
63 Participants
|
|
Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Swelling
|
10 Participants
|
18 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=202 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
|
31 Participants
|
22 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
Redness
|
39 Participants
|
32 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=192 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=197 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
|
11 Participants
|
18 Participants
|
|
Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
Redness
|
33 Participants
|
25 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. 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=202 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 Reactions Based on the Functional Grading Scale After the First Vaccination
Feverishness
|
11 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Malaise
|
31 Participants
|
30 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Myalgia
|
23 Participants
|
22 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Headache
|
46 Participants
|
42 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Nausea
|
5 Participants
|
6 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. 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=192 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=197 Participants
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Myalgia
|
25 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Headache
|
20 Participants
|
33 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Nausea
|
10 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Feverishness
|
11 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Malaise
|
32 Participants
|
25 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=202 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
|
2 Participants
|
1 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=192 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=197 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
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline 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=101 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=100 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
|
80 Participants
|
85 Participants
|
PRIMARY outcome
Timeframe: Baseline 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=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 8-10 Days Following 1 Dose of Vaccine
|
63 Participants
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline 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 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=100 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=98 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
|
86 Participants
|
87 Participants
|
PRIMARY outcome
Timeframe: Baseline 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. One participant was excluded due to the blood being collected after administration of the second vaccination.
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 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=98 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 1 Dose of Vaccine
|
66 Participants
|
83 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=101 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=100 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 at 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 0
|
14 Participants
|
9 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 at 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 8
|
85 Participants
|
89 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=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 Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 0
|
24 Participants
|
25 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 at 8-10 Days Following 1 Dose of H1N1 Vaccine
Day 8
|
80 Participants
|
84 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=100 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=98 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
|
90 Participants
|
90 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. One participant was excluded due to the blood being collected after administration of the second vaccination.
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=98 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 Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
|
79 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 8-10 and 21 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants prior to the initial vaccination as well as 8-10 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=95 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=95 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 and 21 Days Following 2 Doses of H1N1 Vaccine
Day 8-10
|
86 Participants
|
83 Participants
|
|
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 and 21 Days Following 2 Doses of H1N1 Vaccine
Day 21
|
84 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic 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 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=94 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=100 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
|
68 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic 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=95 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=101 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
|
70 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Day 8-10 and Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.
Blood was collected from all participants at Day 8-10 and 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=95 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=95 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 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine
Day 21
|
88 Participants
|
87 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 at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine
Day 8-10
|
88 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Day 8-10 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic 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=94 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=100 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 8-10 Days Following 2 Doses of H1N1 Vaccine
|
80 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 21 after the second vaccinationPopulation: Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic 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=95 Participants
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
|
H1N1 Vaccine 30 Mcg
n=101 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 2 Doses of H1N1 Vaccine
|
79 Participants
|
93 Participants
|
Adverse Events
H1N1 Vaccine 15 Mcg
H1N1 Vaccine 30 Mcg
Serious adverse events
| Measure |
H1N1 Vaccine 15 Mcg
n=202 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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.50%
1/202 • 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.
|
|
Renal and urinary disorders
Renal cyst
|
0.50%
1/202 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/202 • 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
Ischaemic cardiomyopathy
|
0.50%
1/202 • 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
Post procedural complication
|
0.50%
1/202 • 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
Clostridium difficile colitis
|
0.50%
1/202 • 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.
|
|
Surgical and medical procedures
Thoracotomy
|
0.50%
1/202 • 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.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/202 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/202 • 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.
|
|
General disorders
Chest pain
|
0.00%
0/202 • 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.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/202 • 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%
0/202 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/202 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/202 • 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=202 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
Upper respiratory tract infection
|
5.9%
12/202 • 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.
|
4.9%
10/204 • Number of events 10 • 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
|
10.4%
21/202 • Number of events 22 • 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.
|
6.9%
14/204 • 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.
|
|
General disorders
Malaise
|
26.7%
54/202 • Number of events 63 • 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.
|
23.5%
48/204 • Number of events 55 • 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
|
20.8%
42/202 • 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.
|
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.
|
|
Nervous system disorders
Headache
|
28.2%
57/202 • Number of events 66 • 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.
|
28.9%
59/204 • Number of events 75 • 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
|
6.4%
13/202 • 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
Injection site pain
|
24.3%
49/202 • Number of events 63 • 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.
|
23.5%
48/204 • Number of events 61 • 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
|
42.6%
86/202 • Number of events 112 • 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.
|
46.1%
94/204 • Number of events 138 • 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
|
28.2%
57/202 • 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.
|
20.6%
42/204 • Number of events 57 • 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)
|
15.3%
31/202 • Number of events 37 • 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.
|
14.2%
29/204 • 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.
|
|
General disorders
Injection site swelling (measured)
|
17.8%
36/202 • Number of events 42 • 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.
|
17.2%
35/204 • 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.
|
Additional Information
Karen Kotloff, MD
Center for Vaccine Development, University of Maryland
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60