Trial Outcomes & Findings for H1N1 Vaccine at Two Dose Levels in HIV Positive Adults (NCT NCT00992433)

NCT ID: NCT00992433

Last Updated: 2012-05-16

Results Overview

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 10 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 10 titer was an increase by 4-fold or more.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 192 participants
• Primary outcome timeframe: Day 0 prior to vaccination and 10 days after the first vaccination
• Results posted on: 2012-05-16

Participant Flow

Participants were HIV-positive adult males and females recruited from existing patient populations and from the communities at large around the clinical sites. Participants were enrolled between 19Nov2009 and 23Apr2010.

Participant milestones

Measure	15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Overall Study STARTED	95	97
Overall Study COMPLETED	91	90
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

Baseline characteristics by cohort

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants	97 Participants n=7 Participants	192 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45.7 years STANDARD_DEVIATION 9.9 • n=5 Participants	45.3 years STANDARD_DEVIATION 9.3 • n=7 Participants	45.5 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	75 Participants n=7 Participants	151 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants	97 participants n=7 Participants	192 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 10 days after the first 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 not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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 10 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 10 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=34 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine	14 Participants	23 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first 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 not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum 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	14 Participants	21 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 10 days after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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 10 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 10 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=33 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine	15 Participants	23 Participants

PRIMARY outcome

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

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum 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	18 Participants	19 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 180 days after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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 180 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 180 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=33 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	9 Participants	13 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 10 days after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 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 10 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 10 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=60 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=58 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine	32 Participants	42 Participants

PRIMARY outcome

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

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 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 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=58 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=60 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 CD4 200/mL or Greater Stratum 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	30 Participants	42 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 10 days after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 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 10 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 10 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=55 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=57 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine	32 Participants	41 Participants

PRIMARY outcome

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

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=55 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=57 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum 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	30 Participants	40 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 180 days after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 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 180 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 180 titer was an increase by 4-fold or more.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=54 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=55 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	16 Participants	27 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 10 days after the first 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 not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=34 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine Day 0	7 Participants	8 Participants
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine Day 10	16 Participants	24 Participants

PRIMARY outcome

Timeframe: Day 21 after the first 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 not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum 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	16 Participants	22 Participants

PRIMARY outcome

Timeframe: Day 10 after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=33 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine	17 Participants	24 Participants

PRIMARY outcome

Timeframe: Day 21 after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=34 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum 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	20 Participants	22 Participants

PRIMARY outcome

Timeframe: Day 180 after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=33 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=32 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	12 Participants	19 Participants

PRIMARY outcome

Timeframe: Day 0 prior to the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=60 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=61 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine	11 Participants	11 Participants

PRIMARY outcome

Timeframe: Day 10 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=60 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=58 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine	40 Participants	45 Participants

PRIMARY outcome

Timeframe: Day 21 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=58 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=60 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum 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	37 Participants	45 Participants

PRIMARY outcome

Timeframe: Day 10 and Day 21 after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=55 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=57 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine Day 10 Post Second Dose	38 Participants	43 Participants
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine Day 21 Post Second Dose	36 Participants	42 Participants

PRIMARY outcome

Timeframe: Day 180 after the second vaccination

Population: Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=54 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=55 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	25 Participants	32 Participants

PRIMARY outcome

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

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

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	11 Participants	6 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Malaise	22 Participants	20 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	14 Participants	20 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	24 Participants	26 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	12 Participants	9 Participants

PRIMARY outcome

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

Population: Participants who received the second 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

Measure	15 Mcg H1N1 Vaccine n=89 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=94 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	8 Participants	10 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Malaise	14 Participants	14 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	14 Participants	14 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	11 Participants	20 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	7 Participants	9 Participants

PRIMARY outcome

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

Population: Participants who received the first vaccination are included. One participant did not record temperatures. 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

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=96 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Fever After the First Vaccination	0 Participants	1 Participants

PRIMARY outcome

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

Population: Participants who received the second vaccination 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

Measure	15 Mcg H1N1 Vaccine n=89 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=94 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Fever After the Second Vaccination	1 Participants	2 Participants

PRIMARY outcome

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

Population: Participants who received the first 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Tenderness	19 Participants	31 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Pain	14 Participants	22 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Swelling	9 Participants	7 Participants

PRIMARY outcome

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

Population: Participants who received the second 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.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=89 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=94 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Pain	8 Participants	16 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Tenderness	11 Participants	25 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Swelling	8 Participants	6 Participants

PRIMARY outcome

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

Population: Participants who received the first 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

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Redness	12 Participants	13 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Swelling	9 Participants	7 Participants

PRIMARY outcome

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

Population: Participants who received the second 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

Measure	15 Mcg H1N1 Vaccine n=89 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=94 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Redness	12 Participants	8 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Swelling	9 Participants	6 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 diagnosis.

Outcome measures

Measure	15 Mcg H1N1 Vaccine n=95 Participants 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 Participants 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)	0 Participants	0 Participants

Adverse Events

15 Mcg H1N1 Vaccine

Serious events: 8 serious events

Other events: 61 other events

Deaths: 0 deaths

30 Mcg H1N1 Vaccine

Serious events: 5 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	15 Mcg H1N1 Vaccine n=95 participants at risk 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 participants at risk 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Infections and infestations Pneumonia	3.2% 3/95 • 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.	0.00% 0/97 • 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.
Psychiatric disorders Suicidal ideation	1.1% 1/95 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/97 • 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.
Nervous system disorders Cervicobrachial syndrome	1.1% 1/95 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/97 • 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.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	1.1% 1/95 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/97 • 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.
Infections and infestations Cellulitis	1.1% 1/95 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/97 • 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.
Nervous system disorders Hypoaesthesia	1.1% 1/95 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/97 • 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.
Infections and infestations Perineal abscess	0.00% 0/95 • 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.	1.0% 1/97 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Convulsion	0.00% 0/95 • 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.	1.0% 1/97 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Pericarditis	0.00% 0/95 • 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.	1.0% 1/97 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Gastritis	0.00% 0/95 • 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.	1.0% 1/97 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/95 • 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.	1.0% 1/97 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Other adverse events

Measure	15 Mcg H1N1 Vaccine n=95 participants at risk 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.	30 Mcg H1N1 Vaccine n=97 participants at risk 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Investigations Blood pressure increased	8.4% 8/95 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	6.2% 6/97 • 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.
Gastrointestinal disorders Diarrhoea	8.4% 8/95 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.2% 5/97 • Number of events 5 • 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 Oropharyngeal pain	0.00% 0/95 • 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.	5.2% 5/97 • Number of events 5 • 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	8.4% 8/95 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	8.2% 8/97 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Feeling hot	14.7% 14/95 • 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.	14.4% 14/97 • 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.
General disorders Malaise	26.3% 25/95 • Number of events 36 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	28.9% 28/97 • Number of events 34 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Musculoskeletal and connective tissue disorders Myalgia	22.1% 21/95 • 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.	24.7% 24/97 • Number of events 34 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Headache	30.5% 29/95 • 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.	34.0% 33/97 • 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.
Gastrointestinal disorders Nausea	17.9% 17/95 • 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.	13.4% 13/97 • 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.
General disorders Injection site pain	18.9% 18/95 • 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.	30.9% 30/97 • Number of events 38 • 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	26.3% 25/95 • Number of events 30 • 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.	42.3% 41/97 • Number of events 56 • 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	16.8% 16/95 • 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.	17.5% 17/97 • Number of events 21 • 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)	13.7% 13/95 • Number of events 17 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	10.3% 10/97 • Number of events 13 • 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)	14.7% 14/95 • 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.	10.3% 10/97 • Number of events 13 • 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

Hana El Sahly, MD

Baylor College of Medicine

Phone: 713-798-2058

Email: hanae@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60