Trial Outcomes & Findings for Sanofi H1N1 + TIV - Adults and Elderly (NCT NCT00943878)

Last Updated: 2012-08-01

Results Overview

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

805 participants

Primary outcome timeframe

Day 21 after first H1N1 vaccination

Results posted on

2012-08-01

Participant Flow

Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 7AUG2009 and 28AUG2009.

Participant milestones

Participant milestones
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Overall Study STARTED	202	200	203	200
Overall Study COMPLETED	200	198	197	198
Overall Study NOT COMPLETED	2	2	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sanofi H1N1 + TIV - Adults and Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Total n=805 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=93 Participants	103 Participants n=4 Participants	102 Participants n=27 Participants	102 Participants n=483 Participants	408 Participants n=36 Participants
Age, Categorical >=65 years	101 Participants n=93 Participants	97 Participants n=4 Participants	101 Participants n=27 Participants	98 Participants n=483 Participants	397 Participants n=36 Participants
Age Continuous	59.2 years STANDARD_DEVIATION 16.2 • n=93 Participants	58.4 years STANDARD_DEVIATION 16.7 • n=4 Participants	58.5 years STANDARD_DEVIATION 16.6 • n=27 Participants	59.1 years STANDARD_DEVIATION 15.3 • n=483 Participants	58.8 years STANDARD_DEVIATION 16.2 • n=36 Participants
Sex: Female, Male Female	99 Participants n=93 Participants	118 Participants n=4 Participants	104 Participants n=27 Participants	123 Participants n=483 Participants	444 Participants n=36 Participants
Sex: Female, Male Male	103 Participants n=93 Participants	82 Participants n=4 Participants	99 Participants n=27 Participants	77 Participants n=483 Participants	361 Participants n=36 Participants
Region of Enrollment United States	202 participants n=93 Participants	200 participants n=4 Participants	203 participants n=27 Participants	200 participants n=483 Participants	805 participants n=36 Participants

PRIMARY outcome

Timeframe: Day 21 after first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=98 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=101 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=99 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=94 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	90 Participants	87 Participants	91 Participants	82 Participants

PRIMARY outcome

Timeframe: Day 21 after first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=101 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=97 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=101 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=95 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	81 Participants	79 Participants	88 Participants	75 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 180 after the last vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

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; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Blood was collected from participants 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 first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=98 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=101 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=99 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=94 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	84 Participants	83 Participants	89 Participants	78 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=101 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=97 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=101 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=95 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	78 Participants	72 Participants	78 Participants	68 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination 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

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	12 Participants	11 Participants	11 Participants	12 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	12 Participants	12 Participants	7 Participants	13 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Malaise	30 Participants	41 Participants	27 Participants	33 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	23 Participants	24 Participants	16 Participants	23 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	43 Participants	44 Participants	35 Participants	44 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=193 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=189 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	14 Participants	8 Participants	12 Participants	10 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Malaise	29 Participants	29 Participants	35 Participants	23 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	18 Participants	14 Participants	19 Participants	14 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	28 Participants	26 Participants	29 Participants	21 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	6 Participants	6 Participants	4 Participants	8 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: Participants who received the third vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=190 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=185 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=183 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=188 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Feverishness	6 Participants	8 Participants	5 Participants	5 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Malaise	17 Participants	15 Participants	18 Participants	14 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Myalgia	10 Participants	12 Participants	11 Participants	6 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Headache	16 Participants	19 Participants	17 Participants	15 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination Nausea	4 Participants	5 Participants	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Fever After the First Vaccination	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=193 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=188 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Fever After the Second Vaccination	0 Participants	2 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post third vaccination

Population: Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=190 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=184 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=183 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=188 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Fever After the Third Vaccination	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: Participants who received the first H1N1 vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Pain	26 Participants	32 Participants	26 Participants	11 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Tenderness	45 Participants	46 Participants	47 Participants	29 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination Swelling	18 Participants	14 Participants	16 Participants	20 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: Participants who received the second H1N1 vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=194 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=189 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=188 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Tenderness	51 Participants	44 Participants	58 Participants	37 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Pain	28 Participants	22 Participants	30 Participants	19 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination Swelling	28 Participants	17 Participants	20 Participants	25 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: Participants who received the TIV vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=190 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=189 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination Pain	32 Participants	57 Participants	46 Participants	48 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination Tenderness	71 Participants	93 Participants	80 Participants	84 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination Swelling	27 Participants	27 Participants	22 Participants	28 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first placebo vaccination

Population: Participants who received the first placebo vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination Pain	12 Participants	14 Participants	13 Participants	11 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination Tenderness	21 Participants	14 Participants	21 Participants	21 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination Swelling	12 Participants	18 Participants	12 Participants	14 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second placebo vaccination

Population: Participants who received the second placebo vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination 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. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=194 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=185 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=183 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination Pain	11 Participants	9 Participants	5 Participants	8 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination Tenderness	15 Participants	7 Participants	9 Participants	17 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination Swelling	25 Participants	13 Participants	14 Participants	13 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first H1N1 vaccination

Population: Participants who received the first H1N1 vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Redness	32 Participants	33 Participants	27 Participants	31 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination Swelling	19 Participants	16 Participants	19 Participants	21 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second H1N1 vaccination

Population: Participants who received the second H1N1 vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=194 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=189 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=188 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Redness	29 Participants	27 Participants	29 Participants	35 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination Swelling	29 Participants	18 Participants	19 Participants	27 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post TIV vaccination

Population: Participants who received the TIV vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=190 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=189 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Redness	31 Participants	40 Participants	30 Participants	37 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination Swelling	28 Participants	27 Participants	21 Participants	28 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first placebo vaccination

Population: Participants who received the first placebo vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=190 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination Redness	34 Participants	19 Participants	21 Participants	37 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination Swelling	12 Participants	20 Participants	12 Participants	28 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second placebo vaccination

Population: Participants who received the second placebo vaccination are included. Analyses are as treated.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=194 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=185 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=183 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=192 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination Redness	30 Participants	25 Participants	26 Participants	30 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination Swelling	27 Participants	17 Participants	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 63

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=89 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=88 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	46 Participants	40 Participants	38 Participants	39 Participants
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	52 Participants	48 Participants	46 Participants	47 Participants
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	34 Participants	31 Participants	36 Participants	39 Participants

SECONDARY outcome

Timeframe: Day 63

Population: Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=92 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=87 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	66 Participants	62 Participants	53 Participants	57 Participants
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	37 Participants	27 Participants	34 Participants	31 Participants
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	14 Participants	14 Participants	20 Participants	18 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=94 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=92 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	85 Participants	77 Participants	85 Participants	75 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 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 second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=96 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=92 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=93 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	80 Participants	73 Participants	72 Participants	65 Participants

SECONDARY outcome

Timeframe: Day 63

Population: Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=89 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=88 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	79 Participants	77 Participants	78 Participants	81 Participants
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	84 Participants	80 Participants	77 Participants	84 Participants
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	81 Participants	75 Participants	78 Participants	81 Participants

SECONDARY outcome

Timeframe: Day 63

Population: Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Outcome measures

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=92 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=87 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H1 antigen	85 Participants	82 Participants	81 Participants	87 Participants
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV H3 antigen	86 Participants	80 Participants	83 Participants	77 Participants
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination TIV B antigen	71 Participants	69 Participants	68 Participants	62 Participants

SECONDARY outcome

Timeframe: Day 21 after second H1N1 vaccination

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=94 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=92 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=90 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	89 Participants	82 Participants	87 Participants	80 Participants

SECONDARY outcome

Timeframe: Day 21 after second H1N1 vaccination

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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

Outcome measures
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=96 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=92 Participants Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=93 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=91 Participants Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	83 Participants	78 Participants	81 Participants	71 Participants

Adverse Events

Group 1: H1N1+Placebo; H1N1+Placebo; TIV

Serious events: 5 serious events

Other events: 167 other events

Deaths: 0 deaths

Group 2: H1N1+TIV; H1N1+Placebo; Placebo

Serious events: 7 serious events

Other events: 170 other events

Deaths: 0 deaths

Group 3: H1N1+Placebo; H1N1+TIV; Placebo

Serious events: 12 serious events

Other events: 169 other events

Deaths: 0 deaths

Group 4: TIV+Placebo; H1N1+Placebo; H1N1

Serious events: 13 serious events

Other events: 175 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: H1N1+Placebo; H1N1+Placebo; TIV n=202 participants at risk Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Group 2: H1N1+TIV; H1N1+Placebo; Placebo n=200 participants at risk Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Group 3: H1N1+Placebo; H1N1+TIV; Placebo n=203 participants at risk Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Group 4: TIV+Placebo; H1N1+Placebo; H1N1 n=200 participants at risk Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
General disorders Injection site haematoma	8.9% 18/202 • Number of events 18 • 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.	15.0% 30/200 • Number of events 35 • 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.	9.9% 20/203 • Number of events 26 • 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.	9.0% 18/200 • Number of events 20 • 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 Nasal congestion	1.5% 3/202 • Number of events 3 • 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.	2.0% 4/200 • Number of events 4 • 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.	5.9% 12/203 • 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.	3.0% 6/200 • Number of events 6 • 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 Rhinorrhoea	3.0% 6/202 • Number of events 7 • 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.	3.0% 6/200 • Number of events 6 • 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.	2.0% 4/203 • Number of events 4 • 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.	5.0% 10/200 • 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.
Infections and infestations Upper respiratory tract infection	7.9% 16/202 • Number of events 16 • 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.	9.0% 18/200 • Number of events 18 • 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.	11.3% 23/203 • Number of events 23 • 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.	9.0% 18/200 • Number of events 19 • 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	12.9% 26/202 • Number of events 32 • 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.	12.0% 24/200 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	9.9% 20/203 • Number of events 24 • 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.	12.0% 24/200 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Malaise	29.2% 59/202 • Number of events 76 • 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.	30.5% 61/200 • Number of events 85 • 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.	28.1% 57/203 • Number of events 80 • 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.	27.5% 55/200 • Number of events 70 • 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 51 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	20.0% 40/200 • Number of events 50 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	19.2% 39/203 • Number of events 46 • 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.	18.5% 37/200 • Number of events 43 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Headache	31.7% 64/202 • Number of events 87 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	31.0% 62/200 • Number of events 89 • 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.	29.6% 60/203 • Number of events 81 • 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.	30.0% 60/200 • Number of events 80 • 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	8.9% 18/202 • 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.	10.5% 21/200 • 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.	7.9% 16/203 • Number of events 20 • 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.	11.0% 22/200 • Number of events 27 • 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	32.7% 66/202 • Number of events 97 • 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.	43.5% 87/200 • Number of events 109 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	35.5% 72/203 • Number of events 91 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	33.5% 67/200 • Number of events 89 • 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	48.5% 98/202 • Number of events 184 • 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.	57.5% 115/200 • Number of events 159 • 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.	54.7% 111/203 • Number of events 162 • 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.	54.5% 109/200 • Number of events 166 • 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	36.1% 73/202 • Number of events 115 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	33.5% 67/200 • Number of events 107 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	35.0% 71/203 • Number of events 97 • 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.	37.5% 75/200 • Number of events 118 • 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)	28.2% 57/202 • Number of events 88 • 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.	28.0% 56/200 • Number of events 73 • 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.	24.6% 50/203 • Number of events 67 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	29.5% 59/200 • Number of events 84 • 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)	30.2% 61/202 • Number of events 93 • 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.	29.5% 59/200 • Number of events 81 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	25.6% 52/203 • Number of events 69 • 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.	30.5% 61/200 • Number of events 89 • 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

Sharon E. Frey, M.D.

Division of Infectious Diseases and Immunology, Saint Louis University Medical School

Phone: 314-977-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60