Trial Outcomes & Findings for A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults (NCT NCT02100631)

Last Updated: 2023-06-28

Results Overview

The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

398 participants

Primary outcome timeframe

Day 11

Results posted on

2023-06-28

Participant Flow

This study included healthy volunteers (46 - 64 years) who were not previously immunized against cholera. A total of 398 subjects randomized, of which 299 received study treatment and 99 received placebo. A total of 36 subjects from the treatment group continued in the Immune Sub-study population. The historical control subjects are not included in the protocol enrollment number for PXVX-VC-200-005. They are solely a comparator population.

Participant milestones

Participant milestones
Measure	PXVX0200 in Older Adults PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 1x10\^9 CFU in a liquid suspension	Placebo in Older Adults Placebo physiological saline	Historical Control: Adults Aged 18-45 This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Overall Study STARTED	299	99	2688
Overall Study COMPLETED	292	95	2688
Overall Study NOT COMPLETED	7	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PXVX0200 in Older Adults PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 1x10\^9 CFU in a liquid suspension	Placebo in Older Adults Placebo physiological saline
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	3	4
Overall Study 3 subjects randomized to treatment unable to receive vaccine as product not available,	3	0

Baseline Characteristics

A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PXVX0200 in Older Adults n=299 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Placebo in Older Adults n=99 Participants The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=2688 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Total n=3086 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 4.99 • n=5 Participants	54.1 years STANDARD_DEVIATION 5.20 • n=7 Participants	30.0 years STANDARD_DEVIATION 7.8 • n=5 Participants	33.1 years STANDARD_DEVIATION NA • n=4 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	52 Participants n=7 Participants	1482 Participants n=5 Participants	1698 Participants n=4 Participants
Sex: Female, Male Male	135 Participants n=5 Participants	47 Participants n=7 Participants	1206 Participants n=5 Participants	1388 Participants n=4 Participants
Age, Categorical Between 46-64 years (inclusive) · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 46-64 years (inclusive) · Between 18 and 65 years	299 Participants n=5 Participants	99 Participants n=7 Participants	2688 Participants n=5 Participants	3086 Participants n=4 Participants
Age, Categorical Between 46-64 years (inclusive) · >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants	19 Participants n=7 Participants	671 Participants n=5 Participants	758 Participants n=4 Participants
Race (NIH/OMB) White	221 Participants n=5 Participants	77 Participants n=7 Participants	1855 Participants n=5 Participants	2153 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	50 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants
Region of Enrollment United States	299 participants n=5 Participants	99 participants n=7 Participants	2341 participants n=5 Participants	2739 participants n=4 Participants
Region of Enrollment Australia	0 participants n=5 Participants	0 participants n=7 Participants	347 participants n=5 Participants	347 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 11

Population: Immunogenicity Evaluable Population (IEP)

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=291 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=2687 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults Placebo physiological saline
Seroconversion Rate at Day 11	90.4 % of participants Interval 86.4 to 93.5	93.5 % of participants Interval 92.5 to 94.4	—

SECONDARY outcome

Timeframe: Day 11

Population: IEP

The Day 11 vibriocidal GMTs were compared between older and younger adults.

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=291 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=2688 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults n=99 Participants Placebo physiological saline
Geometric Mean Titer (GMT)	4282 Geometric Mean Titer Interval 3344.0 to 5484.0	9688 Geometric Mean Titer Interval 9067.0 to 10351.0	44 Geometric Mean Titer Interval 36.0 to 56.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29

Population: IEP

The cumulative seroconversion through Day 29 for older adults was compared to the Day 11 seroconversion for the younger adults aged 18 - 45 yrs. Seroconversion is defined as a 4-fold rise in antibody titer relative to baseline values.

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=291 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=2687 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults n=99 Participants Placebo physiological saline
Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults	94.2 % of participants Interval 90.8 to 96.6	93.5 % of participants Interval 92.5 to 94.4	1.0 % of participants Interval 0.0 to 5.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 11

Population: IEP. Placebo was not included in this additional bridging analysis as increase in SVA titer from Day 1 to 11 is not applicable for placebo subjects.

The mean log2 fold change between Day 1 and Day 11 in classical Inaba vibriocidal antibody titer attained by older adults was compared to the younger adults aged 18 - 45 yrs.

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=291 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=2687 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults Placebo physiological saline
Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11	6.6 Fold Change in Titer from Day 1 Interval 6.2 to 7.0	7.1 Fold Change in Titer from Day 1 Interval 7.0 to 7.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 11

Population: IEP. The Historical Control population is not included as testing against these other biotypes/serotypes was not included in that study.

Seroconversion of the vibriocidal antibody response against 4 V. cholerae biotypes/serotypes - classical Inaba, El Tor Inaba, classical Ogawa and El Tor Ogawa was assessed.

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=291 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=99 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults Placebo physiological saline
Seroconversion Against Other V. Cholerae Biotypes/Serotypes Classical Inaba	90.4 % of participants Interval 86.4 to 93.5	0 % of participants Interval 0.0 to 3.7	—
Seroconversion Against Other V. Cholerae Biotypes/Serotypes El Tor Inaba	91.0 % of participants Interval 87.1 to 94.1	5.1 % of participants Interval 1.7 to 11.4	—
Seroconversion Against Other V. Cholerae Biotypes/Serotypes Classical Ogawa	73.2 % of participants Interval 67.7 to 78.2	2.0 % of participants Interval 0.2 to 7.1	—
Seroconversion Against Other V. Cholerae Biotypes/Serotypes El Tor Ogawa	71.4 % of participants Interval 65.8 to 76.5	6.1 % of participants Interval 2.3 to 12.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 11

Population: Immune Sub-Study Population. The Historical Control population is not included as anti-CT levels were not assessed in that study.

The seroconversion of anti-Cholera Toxin (CT) antibody response in older adults was assessed. Seroconversion is defined as a 4-fold rise in anti-CT antibody titer relative to baseline values.

Outcome measures

Outcome measures
Measure	PXVX0200 in Older Adults n=36 Participants PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Historical Control: Adults Aged 18-45 n=9 Participants This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118	Placebo in Older Adults Placebo physiological saline
Anti-CT Antibody Response in Older Adults	55.6 % of participants Interval 38.1 to 72.1	0 % of participants Interval 0.0 to 33.6	—

Adverse Events

PXVX0200 in Older Adults

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo in Older Adults

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PXVX0200 in Older Adults n=296 participants at risk PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Placebo in Older Adults n=99 participants at risk The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
Cardiac disorders Atrial Fibrillation	0.34% 1/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	0.00% 0/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.34% 1/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	0.00% 0/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Cardiac disorders Myocardial Infarction	0.34% 1/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	0.00% 0/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.

Other adverse events

Other adverse events
Measure	PXVX0200 in Older Adults n=296 participants at risk PXVX0200 is a live-attenuated cholera vaccine for single-dose oral administration. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.	Placebo in Older Adults n=99 participants at risk The placebo consisted of 100 mL of physiological saline administered orally. Physiological saline was sourced by the clinical sites. Subjects will be randomly assigned 3:1 to receive PXVX0200 (300) or placebo (100). Each subject will have at least 4 visits composed of a screening visit, a vaccination visit (Day 1), and post-vaccination visits at Day 11, and Day 29 telephone contacts will be made on Day 91 and 181.
General disorders Fatigue	3.7% 11/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	3.0% 3/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Nervous system disorders Back Pain	2.0% 6/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	2.0% 2/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Gastrointestinal disorders Decreased Appetite	1.7% 5/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	0.00% 0/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Gastrointestinal disorders Flatulence	1.0% 3/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	2.0% 2/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Skin and subcutaneous tissue disorders Rash	1.0% 3/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	2.0% 2/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Nervous system disorders Headache	1.0% 3/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	1.0% 1/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 3/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	1.0% 1/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.
Gastrointestinal disorders Nausea	1.0% 3/296 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.	0.00% 0/99 • Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit. The Historical Control population is not included in this section as comparisons were not specified to be conducted in the protocol. Adverse events are reported for the safety population comprised of all randomized subjects who received either PXVX0200 or placebo.

Additional Information

David Cassie, Scientist, Clinical Research

Emergent BioSolutions Canada Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place