Trial Outcomes & Findings for Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America (NCT NCT00312663)

Last Updated: 2018-11-26

Results Overview

An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

30 days post vaccination

Results posted on

2018-11-26

Participant Flow

18 immunized subjects

18 subjects were randomly assigned to the immunization phase for each of the 2 vaccine formulations.

Participant milestones

Participant milestones
Measure	10ug Dose FMP011 Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Controls (IC) 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.
Immunization Phase STARTED	5	13	0
Immunization Phase COMPLETED	5	12	0
Immunization Phase NOT COMPLETED	0	1	0
Challenge Phase STARTED	0	10	6
Challenge Phase COMPLETED	0	10	6
Challenge Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	10ug Dose FMP011 Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Controls (IC) 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.
Immunization Phase Adverse Event	0	1	0

Baseline Characteristics

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10ug Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Control (IC) n=6 Participants 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge	Total n=24 Participants Total of all reporting groups
Age, Continuous	30.8 years STANDARD_DEVIATION 7.9 • n=5 Participants	32.8 years STANDARD_DEVIATION 8.1 • n=7 Participants	24.5 years STANDARD_DEVIATION 4.9 • n=5 Participants	32.2 years STANDARD_DEVIATION 7.9 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days post vaccination

Population: The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Subjects from the IC group were not evaluated for AE's and there for not included in the data. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe

Outcome measures

Outcome measures
Measure	10ug Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Control (IC) 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 1	5 adverse events	9 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 2	0 adverse events	4 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Pain - Grade 3	0 adverse events	0 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 1	1 adverse events	1 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 2	1 adverse events	1 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Redness - Grade 3	1 adverse events	2 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 1	1 adverse events	2 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 2	0 adverse events	0 adverse events	—
Safety - Most Frequently Reported Adverse Events and Grade Swelling - Grade 3	0 adverse events	2 adverse events	—

SECONDARY outcome

Timeframe: Days 0, 28, 42, and 84

Population: nAnti-LSA-1 Antibody Response in Titer units on Days 0, 28, 42 and 84

Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84

Outcome measures

Outcome measures
Measure	10ug Dose FMP011 n=5 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 n=13 Participants Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Control (IC) n=6 Participants 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84 Day 0	36.2 Titer units Interval 23.7 to 644.0	43.15 Titer units Interval -10.0 to 475.9	NA Titer units Didn't participate in phase
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84 Day 28	514.4 Titer units Interval 51.9 to 3523.3	462.0 Titer units Interval 41.1 to 6161.0	NA Titer units Didn't participate in phase
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84 Day 42	NA Titer units Didn't' participate in Challenge Phase	36527.0 Titer units Interval 1774.9 to 85080.0	21.1 Titer units Interval -10.0 to 248.5
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84 Day 84	NA Titer units Didn't' participate in Challenge Phase	9180.0 Titer units Interval 834.0 to 18131.0	30 Titer units Interval 14.0 to 235.4

Adverse Events

10ug Dose FMP011

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

50ug Dose FMP011

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Infectivity Control (IC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

James Cummings, MD

WRAIR

Phone: 301-319-9312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	10ug Dose FMP011 n=5 participants at risk Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	50ug Dose FMP011 n=13 participants at risk Falciparum Malaria Protein 11 with AS01B adjuvant Falciparum Malaria Protein 11 with AS01B adjuvant.: malaria experimental vaccine	Infectivity Control (IC) 10 Subject from the high dose group and six non immunized subjects enrolled prior to challenge to serve as IC's for malaria sporozoite challenge
General disorders Pain	80.0% 4/5 • Number of events 4 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	84.6% 11/13 • Number of events 11 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
General disorders Swelling	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	23.1% 3/13 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Skin and subcutaneous tissue disorders Redness	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	23.1% 3/13 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
General disorders Fever	60.0% 3/5 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	38.5% 5/13 • Number of events 5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	15.4% 2/13 • Number of events 2 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Nervous system disorders Headache	60.0% 3/5 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	69.2% 9/13 • Number of events 9 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
General disorders Malaise	60.0% 3/5 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	69.2% 9/13 • Number of events 9 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Musculoskeletal and connective tissue disorders Myalgia	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	53.8% 7/13 • Number of events 7 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
General disorders Fatigue	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	69.2% 9/13 • Number of events 9 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Musculoskeletal and connective tissue disorders Joint pain	60.0% 3/5 • Number of events 3 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	30.8% 4/13 • Number of events 4 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Musculoskeletal and connective tissue disorders Chills	40.0% 2/5 • Number of events 2 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	53.8% 7/13 • Number of events 7 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Injury, poisoning and procedural complications Bruise	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Infections and infestations Flu-like symptoms	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Musculoskeletal and connective tissue disorders Stiffness	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Blood and lymphatic system disorders Swollen glands	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.
Blood and lymphatic system disorders Swollen glands - neck and axillary	0.00% 0/5 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	7.7% 1/13 • Number of events 1 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.	— 0/0 • Up to 6 months Evaluate the safety by 1) occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period); and 3) the occurrence of SAEs during the study period. IC group was not included in AE evaluations and there for not reported in the FCSR.