Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943631
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : April 13, 2011
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inactivated H1N1 Vaccine
Enrollment 406
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Period Title: Overall Study
Started 202 204
Completed 198 202
Not Completed 4 2
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg Total
Hide Arm/Group Description Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. Total of all reporting groups
Overall Number of Baseline Participants 202 204 406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 406 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
102
  50.5%
100
  49.0%
202
  49.8%
>=65 years
100
  49.5%
104
  51.0%
204
  50.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 204 participants 406 participants
58.7  (17.1) 59.6  (16.4) 59.1  (16.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 204 participants 406 participants
Female
103
  51.0%
112
  54.9%
215
  53.0%
Male
99
  49.0%
92
  45.1%
191
  47.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 202 participants 204 participants 406 participants
202 204 406
1.Primary Outcome
Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Day 0 through Day 180 after last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
0 0
2.Primary Outcome
Title Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Hide Description 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.
Time Frame Day 0-7 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
Pain 36 34
Tenderness 58 75
Swelling 27 16
3.Primary Outcome
Title Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Hide Description 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.
Time Frame Day 0-7 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 192 197
Measure Type: Number
Unit of Measure: Participants
Pain 27 27
Tenderness 54 63
Swelling 10 18
4.Primary Outcome
Title Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
Hide Description 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.
Time Frame Day 0-7 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
Swelling 31 22
Redness 39 32
5.Primary Outcome
Title Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
Hide Description 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.
Time Frame Day 0-7 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 192 197
Measure Type: Number
Unit of Measure: Participants
Swelling 11 18
Redness 33 25
6.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Hide Description 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.
Time Frame Day 0-7 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
Feverishness 11 5
Malaise 31 30
Myalgia 23 22
Headache 46 42
Nausea 5 6
7.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Hide Description 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.
Time Frame Day 0-7 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 192 197
Measure Type: Number
Unit of Measure: Participants
Feverishness 11 10
Malaise 32 25
Myalgia 25 18
Headache 20 33
Nausea 10 11
8.Primary Outcome
Title Number of Participants Reporting Fever After the First Vaccination
Hide Description 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.
Time Frame Day 0-7 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 202 204
Measure Type: Number
Unit of Measure: Participants
2 1
9.Primary Outcome
Title Number of Participants Reporting Fever After the Second Vaccination
Hide Description 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.
Time Frame Day 0-7 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety ITT cohort.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 192 197
Measure Type: Number
Unit of Measure: Participants
2 0
10.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 8-10 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 101 100
Measure Type: Number
Unit of Measure: Participants
80 85
11.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 8-10 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 100 104
Measure Type: Number
Unit of Measure: Participants
63 69
12.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 21 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 100 98
Measure Type: Number
Unit of Measure: Participants
86 87
13.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 21 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 98 103
Measure Type: Number
Unit of Measure: Participants
66 83
14.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to and Day 8-10 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 101 100
Measure Type: Number
Unit of Measure: Participants
Day 0 14 9
Day 8 85 89
15.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 prior to and Day 8-10 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 100 104
Measure Type: Number
Unit of Measure: Participants
Day 0 24 25
Day 8 80 84
16.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 100 98
Measure Type: Number
Unit of Measure: Participants
90 90
17.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 98 103
Measure Type: Number
Unit of Measure: Participants
79 94
18.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 8-10 and 21 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 95 95
Measure Type: Number
Unit of Measure: Participants
Day 8-10 86 83
Day 21 84 82
19.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 8-10 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 94 100
Measure Type: Number
Unit of Measure: Participants
68 84
20.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Day 21 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 95 101
Measure Type: Number
Unit of Measure: Participants
70 82
21.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 8-10 and Day 21 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 95 95
Measure Type: Number
Unit of Measure: Participants
Day 8-10 88 86
Day 21 88 87
22.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 8-10 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 94 100
Measure Type: Number
Unit of Measure: Participants
80 92
23.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 21 after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description:
Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Overall Number of Participants Analyzed 95 101
Measure Type: Number
Unit of Measure: Participants
79 93
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Hide Arm/Group Description Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
All-Cause Mortality
H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/202 (2.97%)      5/204 (2.45%)    
Cardiac disorders     
Ischaemic cardiomyopathy * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Atrial fibrillation * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Gastrointestinal disorders     
Umbilical hernia, obstructive * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
General disorders     
Chest pain * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Infections and infestations     
Clostridium difficile colitis * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Injury, poisoning and procedural complications     
Post procedural complication * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lipoma * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Nervous system disorders     
Syncope * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Renal and urinary disorders     
Renal cyst * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
Urinary incontinence * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Pulmonary embolism * 1  0/202 (0.00%)  0 1/204 (0.49%)  1
Surgical and medical procedures     
Thoracotomy * 1  1/202 (0.50%)  1 0/204 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
H1N1 Vaccine 15 Mcg H1N1 Vaccine 30 Mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   149/202 (73.76%)      150/204 (73.53%)    
Gastrointestinal disorders     
Nausea  1  13/202 (6.44%)  15 17/204 (8.33%)  17
General disorders     
Feeling hot  1  21/202 (10.40%)  22 14/204 (6.86%)  15
Malaise  1  54/202 (26.73%)  63 48/204 (23.53%)  55
Injection site pain  1  49/202 (24.26%)  63 48/204 (23.53%)  61
Tenderness  1 [1]  86/202 (42.57%)  112 94/204 (46.08%)  138
Injection site erythema  1  57/202 (28.22%)  72 42/204 (20.59%)  57
Injection site swelling (functional grading)  1 [2]  31/202 (15.35%)  37 29/204 (14.22%)  34
Injection site swelling (measured)  1 [2]  36/202 (17.82%)  42 35/204 (17.16%)  40
Infections and infestations     
Upper respiratory tract infection * 1  12/202 (5.94%)  12 10/204 (4.90%)  10
Musculoskeletal and connective tissue disorders     
Myalgia  1  42/202 (20.79%)  48 34/204 (16.67%)  40
Nervous system disorders     
Headache  1  57/202 (28.22%)  66 59/204 (28.92%)  75
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[1]
Tenderness was solicited as a reaction at the vaccination site.
[2]
Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karen Kotloff, MD
Organization: Center for Vaccine Development, University of Maryland
Phone: 401-706-5328
EMail: kkotloff@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943631    
Other Study ID Numbers: 09-0053
N01AI80057C
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: March 17, 2011
Results First Posted: April 13, 2011
Last Update Posted: October 31, 2012