Trial Outcomes & Findings for Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera (NCT NCT01895855)
NCT ID: NCT01895855
Last Updated: 2023-06-28
Results Overview
Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) diarrhea.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
197 participants
Primary outcome timeframe
Ten days after vaccination
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
PXVX0200
Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10\^8 to 2x10\^9 CFU in a liquid suspension
|
Placebo
Biological: Placebo physiological saline
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
102
|
|
Overall Study
COMPLETED
|
95
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Baseline characteristics by cohort
| Measure |
PXVX0200
n=95 Participants
Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x10\^8 to 2x10\^9 CFU in a liquid suspension
|
Placebo
n=102 Participants
Biological: Placebo physiological saline
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
197 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
|
31.5 years
n=5 Participants
|
30.6 years
n=7 Participants
|
31.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
102 participants
n=7 Participants
|
197 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Ten days after vaccinationDetermine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) diarrhea.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Moderate to Severe Diarrhea
|
5.7 percentage of participants
|
59.1 percentage of participants
|
PRIMARY outcome
Timeframe: Ninety days after vaccinationDetermine whether a single dose of PXVX0200 provides significant greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) of diarrhea.
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Moderate to Severe Diarrhea
|
12.1 percentage of participants
|
59.1 percentage of participants
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to Treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 10 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
Total Weight of Diarrheal Stools Following the 10 Day Cholera Challenge
|
309 mL
Interval 154.0 to 18164.0
|
4524 mL
Interval 140.0 to 24374.0
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to Treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Total weight (converted to volume) per subject of diarrheal stools measured from subjects with diarrhea following the 90 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
Total Weight of Diarrheal Stools Following the 90 Day Cholera Challenge
|
603 mL
Interval 22.0 to 9950.0
|
4524 mL
Interval 140.0 to 24374.0
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Incidence of mild or worse (any severity) diarrhea following the 10 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Diarrhea of Any Severity Following a 10 Day Cholera Challenge
|
14.3 % of participants
|
92.4 % of participants
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Incidence of mild or worse (any severity) diarrhea following the 90 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Diarrhea of Any Severity Following a 90 Day Challenge
|
45.5 % of participants
|
92.4 % of participants
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Incidence of mild or worse fever following the 10 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Fever Following the 10 Day Cholera Challenge
|
2.9 % of participants
|
27.3 % of participants
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat population comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Incidence of mild or worse fever following the 90 day cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Fever Following the 90 Day Cholera Challenge
|
6.1 % of participants
|
27.3 % of participants
|
SECONDARY outcome
Timeframe: Through 10 Days post challengePopulation: Intent to treat (ITT) population
Number of days of fecal shedding of wild type V. cholerae following 10 Day Challenge.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
Number of Days With Fecal Shedding Following 10 Day Challenge
|
0.0 Days
Interval 0.0 to 2.0
|
3.0 Days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Through 10 days following challengePopulation: Intent to treat (ITT) population
Number of days of fecal shedding of wild type V. cholerae following 90 Day Challenge
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
Number of Days With Fecal Shedding Following 90 Day Challenge
|
2.0 Days
Interval 1.0 to 3.0
|
3.0 Days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat (ITT) comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Total number of days with a positive stool culture following the 10 Day Cholera challenge.
Outcome measures
| Measure |
PXVX0200
n=35 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
# of Days With Positive Stool Culture Following 10 Day Cholera Challenge
|
0.9 Days
Standard Deviation 1.20
|
3.3 Days
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Through 10 Days following challengePopulation: Intent to treat (ITT) comprising all subjects who were randomized and received either PXVX0200 vaccine or placebo.
Total number of days with a positive stool culture following 90 Day Cholera Challenge
Outcome measures
| Measure |
PXVX0200
n=33 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=66 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
# of Days With Positive Stool Culture Following 90 Day Cholera Challenge
|
2.1 Days
Standard Deviation 1.41
|
3.3 Days
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Following vaccination (Days 1 - 8) and to Day 29Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever following vaccination (through Day 8). Incidence and severity of unsolicited adverse events following vaccination (through Day 29).
Outcome measures
| Measure |
PXVX0200
n=95 Participants
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU
|
Placebo
n=102 Participants
Biological: Placebo physiological saline
|
|---|---|---|
|
% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination
% of Subjects with Reactogenicity
|
49.5 % of participants
|
50.0 % of participants
|
|
% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination
% of Subjects with Diarrhea Symptoms
|
1.1 % of participants
|
3.0 % of participants
|
|
% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination
% of Subjects with Fever Symptoms
|
2.2 % of participants
|
1.0 % of participants
|
|
% of Participants With Reactogenicity, Diarrhea, Fever or Unsolicited Adverse Events Following Vaccination
% of Subjects with Unsolicited AEs
|
17.9 % of participants
|
16.7 % of participants
|
Adverse Events
PVXV0200
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PVXV0200
n=95 participants at risk
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU.
|
Placebo
n=102 participants at risk
Biological: Placebo physiological saline
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
Other adverse events
| Measure |
PVXV0200
n=95 participants at risk
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8 CFU.
|
Placebo
n=102 participants at risk
Biological: Placebo physiological saline
|
|---|---|---|
|
Eye disorders
Eye pain
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
2/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
General disorders
Fatigue
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
3.9%
4/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
General disorders
Feeling abnormal
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
General disorders
Feeling Hot
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
General disorders
Thirst
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Infections and infestations
Upper Respiratory tract infection
|
3.2%
3/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
2.0%
2/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Injury, poisoning and procedural complications
Sports injury
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Nervous system disorders
Headache
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
2.0%
2/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
2.9%
3/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
2.0%
2/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Vascular disorders
Hypertension
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
General disorders
Pyrexia
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.00%
0/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
2.0%
2/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/95 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
0.98%
1/102 • Unsolicited adverse events were recorded for each vaccine or placebo recipient from the day of vaccination through 28 days after vaccination or 28 days after challenge, whichever was later. SAEs and medically attended AEs were recorded through the end of the follow-up period (Day 181).
|
Additional Information
David Cassie, Scientist, Clinical Research
Emergent BioSolutions Canada Inc.
Phone: 204-275-4589
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60