Trial Outcomes & Findings for Staged Phase I/II Hepatitis C Prophylactic Vaccine (NCT NCT01436357)

NCT ID: NCT01436357

Last Updated: 2019-11-19

Results Overview

Chronic hepatitis C virus (HCV) infection was defined by persistent viremia over a period of 6 months after initial detection of primary infection.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 548 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-11-19

Participant Flow

People who are actively injecting drugs who are at high risk for HCV infection, negative for HCV antibodies and HCV RNA at screening, were recruited at 3 clinical sites experienced in recruiting and retaining people who inject drugs in prospective studies. Participants were enrolled between 19MAR2012 and 28OCT2016.

Participant milestones

Measure	AdCh3NSmut1 and MVA-NSmut One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Study STARTED	274	274
Overall Study Stage 1	49	48
Overall Study Stage 2	225	226
Overall Study COMPLETED	152	146
Overall Study NOT COMPLETED	122	128

Reasons for withdrawal

Measure	AdCh3NSmut1 and MVA-NSmut One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Study Death	5	1
Overall Study Enrolled but not vaccinated	1	1
Overall Study Incarceration	18	20
Overall Study Lost to Follow-up	67	61
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	26	38
Overall Study Physician Decision	3	4
Overall Study Moved out of area	1	2
Overall Study Subject in rehab	0	1

Baseline Characteristics

Staged Phase I/II Hepatitis C Prophylactic Vaccine

Baseline characteristics by cohort

Measure	AdCh3NSmut1 and MVA-NSmut n=274 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=274 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.	Total n=548 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	274 Participants n=5 Participants	274 Participants n=7 Participants	548 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.3 years STANDARD_DEVIATION 7.3 • n=5 Participants	30.4 years STANDARD_DEVIATION 7.2 • n=7 Participants	30.9 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	214 Participants n=5 Participants	212 Participants n=7 Participants	426 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	234 Participants n=5 Participants	235 Participants n=7 Participants	469 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	62 Participants n=5 Participants	51 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) White	159 Participants n=5 Participants	175 Participants n=7 Participants	334 Participants n=5 Participants
Race (NIH/OMB) More than one race	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	274 participants n=5 Participants	274 participants n=7 Participants	548 participants n=5 Participants
IL28B Status CC	111 Participants n=5 Participants	111 Participants n=7 Participants	222 Participants n=5 Participants
IL28B Status CT/TT	163 Participants n=5 Participants	163 Participants n=7 Participants	326 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All randomized are included as treated (one participant randomized to placebo received vaccine) with the following censoring criteria applied: did not receive both vaccinations, HCV infected at baseline, did not have sufficient follow-up to be evaluable for efficacy, or had major protocol deviations compromising the assessment of vaccine efficacy.

Chronic hepatitis C virus (HCV) infection was defined by persistent viremia over a period of 6 months after initial detection of primary infection.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=275 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=273 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months	14 Participants	14 Participants

PRIMARY outcome

Timeframe: 1 month after first vaccination

Population: The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.

Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=274 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=272 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After First Vaccination	70 Participants	48 Participants

PRIMARY outcome

Timeframe: 1 month after second vaccination

Population: The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.

Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=228 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=227 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After Second Vaccination	73 Participants	49 Participants

PRIMARY outcome

Timeframe: 7 days after first vaccination

Population: The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.

Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as "events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating." Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=274 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=272 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After First Vaccination	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 to 29 months

Population: The safety analysis population excludes 1 participant who was not vaccinated. Participants are analyzed as treated.

The occurrence of SAEs was assessed at every study visit. The occurrence of SAEs may also have come to the attention of the investigator by secondary contacts of the participant when they did not present for study visits. Relationship to vaccine was assessed by the site investigator.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=274 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=272 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Occurrence of Vaccine-related Serious Adverse Events (SAEs) From the Time of First Vaccination Through the Entire Study Period	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days after second vaccination

Population: The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.

Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as "events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating." Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=228 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=227 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After Second Vaccination	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 14 days after the last vaccination (Day 56)

Population: The population for this outcome included all participants who received both vaccinations and had immunogenicity data available. Participants are analyzed as treated. Data collected post-HCV infection were excluded from this analysis.

Cell mediated immune response was measured by interferon gamma (IFN-gamma) production by T-cells against each of the six HCV genotype 1b peptide pools in the vaccine. Positivity was defined as i) more than 48 spot forming cells per million PBMC; and ii) at least three times the mean background spots per million PBMC found in ELISpot wells containing cells and peptide diluent (DMSO). A participant was considered a responder if a positive response to at least one in 6 mixtures (pools) of peptides was detected.

Outcome measures

Measure	AdCh3NSmut1 and MVA-NSmut n=125 Participants One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=122 Participants Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Number of Participants With Positive Cell Mediated Immune Response	97 Participants	4 Participants

Adverse Events

AdCh3NSmut1 and MVA-NSmut

Serious events: 40 serious events

Other events: 229 other events

Deaths: 5 deaths

Sodium Chloride Placebo

Serious events: 25 serious events

Other events: 172 other events

Deaths: 2 deaths

Serious adverse events

Measure	AdCh3NSmut1 and MVA-NSmut n=274 participants at risk One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=272 participants at risk Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Gastrointestinal disorders Colitis	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Gastrointestinal disorders Pancreatitis	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Hepatobiliary disorders Hepatitis	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Hepatobiliary disorders Liver Injury	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Abscess	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Abscess Limb	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Abscess Neck	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Arthritis Bacterial	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Bursitis Infective	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Cellulitis	1.5% 4/274 • Number of events 4 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.74% 2/272 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Clostridium Difficile Colitis	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Endocarditis	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Gangrene	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations HIV Infection	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Osteomyelitis	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Pneumonia	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.74% 2/272 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Psoas Abscess	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Staphylococcal Bacteraemia	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Subcutaneous Abscess	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Tooth Abscess	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Infections and infestations Urosepsis	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Facial Bones Fracture	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Head Injury	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Injury	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Overdose	1.8% 5/274 • Number of events 5 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Subdural Haematoma	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Traumatic Liver Injury	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Injury, poisoning and procedural complications Uterine Rupture	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Investigations Foetal Monitoring	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Nervous system disorders Seizure	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Pregnancy, puerperium and perinatal conditions Foetal Death	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Affective Disorder	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Completed Suicide	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Depression	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Mental Status Changes	0.00% 0/274 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Psychotic Disorder	1.1% 3/274 • Number of events 3 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Schizoaffective Disorder	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Suicidal Ideation	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.37% 1/272 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Psychiatric disorders Suicide Attempt	0.73% 2/274 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.74% 2/272 • Number of events 2 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Respiratory, thoracic and mediastinal disorders Asthma	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.36% 1/274 • Number of events 1 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	0.00% 0/272 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.

Other adverse events

Measure	AdCh3NSmut1 and MVA-NSmut n=274 participants at risk One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu).	Sodium Chloride Placebo n=272 participants at risk Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
General disorders Injection site pain	65.0% 178/274 • Number of events 247 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	15.8% 43/272 • Number of events 46 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
General disorders Injection site warmth	19.0% 52/274 • Number of events 62 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	7.0% 19/272 • Number of events 21 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
General disorders Injection site erythema	34.7% 95/274 • Number of events 126 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	22.4% 61/272 • Number of events 77 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
General disorders Injection site induration	28.8% 79/274 • Number of events 98 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	10.7% 29/272 • Number of events 33 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Investigations Body temperature increase	10.2% 28/274 • Number of events 29 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	2.9% 8/272 • Number of events 9 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Nervous system disorders Headache	34.7% 95/274 • Number of events 114 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	23.5% 64/272 • Number of events 74 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
General disorders Malaise	41.6% 114/274 • Number of events 147 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	36.4% 99/272 • Number of events 120 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Musculoskeletal and connective tissue disorders Myalgia	40.9% 112/274 • Number of events 138 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	25.4% 69/272 • Number of events 80 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Gastrointestinal disorders Nausea	18.6% 51/274 • Number of events 64 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	17.6% 48/272 • Number of events 54 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Gastrointestinal disorders Vomiting	9.5% 26/274 • Number of events 28 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	9.6% 26/272 • Number of events 29 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
General disorders Chills	18.6% 51/274 • Number of events 60 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	12.9% 35/272 • Number of events 40 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Gastrointestinal disorders Abdominal pain	16.4% 45/274 • Number of events 57 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	12.5% 34/272 • Number of events 38 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Musculoskeletal and connective tissue disorders Arthralgia	23.0% 63/274 • Number of events 78 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	13.6% 37/272 • Number of events 45 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Investigations Aspartate aminotransferase increased	10.6% 29/274 • Number of events 30 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	10.7% 29/272 • Number of events 31 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Investigations Blood alkaline phosphatase increased	5.5% 15/274 • Number of events 15 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.	4.0% 11/272 • Number of events 11 • Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected. For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.

Additional Information

Kimberly Page, Ph.D., M.P.H. and Andrea Cox, M.D., Ph.D.

University of New Mexico and Johns Hopkins University

Phone: 505-272-2520, 410-502-2715

Email: pagek@salud.unm.edu, acox@jhmi.edu

Results disclosure agreements

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

Restriction type: LTE60