Trial Outcomes & Findings for Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children (NCT NCT02839161)

NCT ID: NCT02839161

Last Updated: 2025-01-13

Results Overview

To evaluate the safety and reactogenicity of three different dose concentrations of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel® in healthy Gabonese children.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: Day 380
• Results posted on: 2025-01-13

Participant Flow

Recruitment and enrollment occurred on an ongoing basis, with each group being recruited and vaccinated in sequence.

Participant milestones

Measure	Low-dose (0,2,4 Months) 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine
Overall Study STARTED	8	8	8	8	8	8	6	6
Overall Study COMPLETED	8	8	8	8	8	8	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children

Baseline characteristics by cohort

Measure	Low-dose (0,2,4 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) n=8 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) n=8 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) n=8 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) n=8 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) n=6 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) n=6 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine	Total n=60 Participants Total of all reporting groups
Age, Continuous	7 years n=5 Participants	8 years n=7 Participants	6.5 years n=5 Participants	8 years n=4 Participants	7.5 years n=21 Participants	7 years n=8 Participants	7.5 years n=8 Participants	6.5 years n=24 Participants	7 years n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	26 Participants n=42 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	34 Participants n=42 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	60 Participants n=42 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Region of Enrollment Gabon	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	8 participants n=21 Participants	8 participants n=8 Participants	6 participants n=8 Participants	6 participants n=24 Participants	60 participants n=42 Participants

PRIMARY outcome

Timeframe: Day 380

To evaluate the safety and reactogenicity of three different dose concentrations of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel® in healthy Gabonese children.

Outcome measures

Measure	Low-dose (0,2,4 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) n=8 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) n=8 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) n=8 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) n=8 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) n=6 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) n=6 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine
Vaccine-Related Adverse Events Number participants with at least 1 AE (any grade)	8 Participants	8 Participants	8 Participants	8 Participants	8 Participants	8 Participants	4 Participants	6 Participants
Vaccine-Related Adverse Events Number participants with at least 1 injection site AE (any grade)	7 Participants	8 Participants	7 Participants	8 Participants	7 Participants	7 Participants	2 Participants	5 Participants
Vaccine-Related Adverse Events Number participants with at least 1 grade 3 (severe) event	2 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14 days after the third vaccination

Population: Overall Numbers of Participants Analyzed in each Arm/Group corresponded to participants who received all 3 study injections, did not have any significant protocol deviations, and who had serum collected and sent to the analyzing laboratory on the specified study day.

To determine the doses of co-administered Na-APR-1 (M74) and Na-GST-1 that result in the highest levels of IgG antibody approximately 14 days after the third vaccination.

Outcome measures

Measure	Low-dose (0,2,4 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) n=8 Participants 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) n=5 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) n=7 Participants 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) n=8 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) n=1 Participants 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) n=5 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) n=5 Participants Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine
IgG Response to Na-GST-1 and Na-APR-1 (M74)	9.52 Arbitrary Units Interval 4.36 to 20.78	9.08 Arbitrary Units Interval 3.81 to 21.64	219.53 Arbitrary Units Interval 13.05 to 3694.51	266.38 Arbitrary Units Interval 84.44 to 840.35	726.89 Arbitrary Units Interval 186.95 to 2826.33	2295.97 Arbitrary Units Interval 2295.97 to 2295.97	2.36 Arbitrary Units Interval 1.48 to 3.74	2.36 Arbitrary Units Interval 1.48 to 3.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 380

To assess and compare the duration of the antibody responses of Na-GST-1 and Na-APR-1 (M74).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 380

To assess the distribution of IgG subclass responses to Na-GST-1 and Na-APR-1 (M74).

Outcome measures

Outcome data not reported

Adverse Events

Low-dose (0,2,4 Months)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Low-dose (0,2,6 Months)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Medium-dose (0,2,4 Months)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Medium-dose (0,2,6 Months)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

High-dose (0,2,4 Months)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

High-dose (0,2,6 Months)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Comparator (0,2,4 Months)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Comparator (0,2,6 Months)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low-dose (0,2,4 Months) n=8 participants at risk 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) n=8 participants at risk 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) n=8 participants at risk 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) n=8 participants at risk 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) n=8 participants at risk 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) n=8 participants at risk 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) n=6 participants at risk Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) n=6 participants at risk Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine
Gastrointestinal disorders Inguinal hernia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • Number of events 1 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.

Other adverse events

Measure	Low-dose (0,2,4 Months) n=8 participants at risk 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Low-dose (0,2,6 Months) n=8 participants at risk 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,4 Months) n=8 participants at risk 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Medium-dose (0,2,6 Months) n=8 participants at risk 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,4 Months) n=8 participants at risk 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	High-dose (0,2,6 Months) n=8 participants at risk 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel	Comparator (0,2,4 Months) n=6 participants at risk Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine	Comparator (0,2,6 Months) n=6 participants at risk Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine
Investigations Alanine aminotransferase increased	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations Blood pressure diastolic increased	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Musculoskeletal and connective tissue disorders Anthralgia	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Respiratory, thoracic and mediastinal disorders Cough	62.5% 5/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Skin and subcutaneous tissue disorders Eczema	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations Haemoglobin decreased	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	50.0% 4/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	62.5% 5/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations Neutrophil count decreased	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations Platelet count decreased	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations White blood cell count decreased	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations White blood cell count increased	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Musculoskeletal and connective tissue disorders Joint swelling	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Investigations Pain in extremity	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Wound infection	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Injury, poisoning and procedural complications Ear injury	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Limb injury	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
General disorders Injection Site Pain	87.5% 7/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	100.0% 8/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	87.5% 7/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	100.0% 8/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	87.5% 7/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	75.0% 6/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	33.3% 2/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	83.3% 5/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
General disorders Injection site swelling	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	50.0% 4/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	50.0% 4/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
General disorders Injection site tenderness	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
General disorders Pyrexia	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	50.0% 4/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	33.3% 2/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Vomiting	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Nausea	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Inguinal hernia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Dental Caries	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Gastrointestinal disorders Abdominal Pain	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Nervous system disorders Hypokinesia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Nervous system disorders Headache	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	50.0% 4/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	37.5% 3/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	33.3% 2/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Cardiac disorders Bradycardia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Cardiac disorders Tachycardia	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Abscess	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Ascariasis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Body tinea	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Bronchitis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Ear infection	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Eczema infected	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Enterobiasis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Influenza	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Malaria	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Measles	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Nasopharyngitis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Plasmodium falciparum infection	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Rhinitis	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Skin infection	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Subcutaneous abscess	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Tinea capitis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	12.5% 1/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Infections and infestations Trichuriasis	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	25.0% 2/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/8 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	16.7% 1/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.	0.00% 0/6 • The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.

Additional Information

David J. Diemert, MD

George Washington University

Phone: 202-994-2909

Email: ddiemert@gwu.edu

Results disclosure agreements

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