Trial Outcomes & Findings for Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (NCT NCT01897402)

Last Updated: 2015-04-23

Results Overview

Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer \<1:8 at baseline or a 4-fold rise in antibody levels.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

525 participants

Primary outcome timeframe

Week 4 after injection

Results posted on

2015-04-23

Participant Flow

Participants recruited and were enrolled at three sites in Maryland between October 21, 2013 and May 22, 2014. The sites screened 1086 subjects with 559 screen failures. The majority, 390 subjects (69.8 %), failed due to inclusion or exclusion criteria (IC/EC). The most common failure criterion was Laboratory abnormalities (150 subjects, 26.8 %).

Other common reasons for screen failure were inability to re-schedule within enrollment window after trial start was delayed (101 subjects, 18.1 % of screen failures) and lost to follow up 65 subjects (11.6%). These two reasons account for 166 (29.7%) subjects who met IC/EC, but did not enter the trial.

Participant milestones

Participant milestones
Measure	Test Vaccine NmVac4-A/C/Y/W-135-DT™ conjugate vaccine	US Licensed Vaccine Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Overall Study STARTED	265	260
Overall Study COMPLETED	246	244
Overall Study NOT COMPLETED	19	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Vaccine n=266 Participants NmVac4-A/C/Y/W-135-DT™ conjugate vaccine	US Licensed Vaccine n=261 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Total n=527 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 11.1 • n=5 Participants	36.0 years STANDARD_DEVIATION 10.88 • n=7 Participants	36.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	112 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	149 Participants n=7 Participants	299 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/ Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Race/Ethnicity, Customized Black/ African-American	176 Participants n=5 Participants	160 Participants n=7 Participants	336 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 after injection

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	Test Vaccine n=222 Participants NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.	US Licensed Vaccine n=226 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.	US Licensed Vaccine - Male Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	US Licensed Vaccine - Female Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Seroresponse (Percent Seroconversion). Serogroup A	70.7 percentage of per protocol participants Interval 64.3 to 76.6	70.1 percentage of per protocol participants Interval 63.6 to 76.1	—	—
Seroresponse (Percent Seroconversion). Serogroup C	66.5 percentage of per protocol participants Interval 59.9 to 72.7	72.5 percentage of per protocol participants Interval 66.1 to 78.3	—	—
Seroresponse (Percent Seroconversion). Serogroup Y	63.1 percentage of per protocol participants Interval 56.3 to 69.4	64.1 percentage of per protocol participants Interval 57.5 to 70.4	—	—
Seroresponse (Percent Seroconversion). Serogroup W-135	66.2 percentage of per protocol participants Interval 59.6 to 72.4	65.9 percentage of per protocol participants Interval 59.3 to 72.1	—	—

SECONDARY outcome

Timeframe: Day 0 to Day 7 after vaccination

Population: Safety Population: All vaccinated participants, grouped by actual vaccine received.

Local and systemic rates from Diary Cards filled by the participants.

Outcome measures

Outcome measures
Measure	Test Vaccine n=151 Participants NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.	US Licensed Vaccine n=114 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.	US Licensed Vaccine - Male n=147 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	US Licensed Vaccine - Female n=113 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Solicited Adverse Events From Diary Cards At least 1 local reaction	53.6 percentage of participants	65.8 percentage of participants	40.8 percentage of participants	46.5 percentage of participants
Solicited Adverse Events From Diary Cards At least 1 systemic reaction	35.1 percentage of participants	37.7 percentage of participants	34.7 percentage of participants	42.5 percentage of participants

SECONDARY outcome

Timeframe: up to 6 months

Population: Safety Population: All vaccinated participants, grouped by actual vaccine received.

Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.

Outcome measures

Outcome measures
Measure	Test Vaccine n=265 Participants NmVac4-A/C/Y/W-135-DT™ conjugate vaccine Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.	US Licensed Vaccine n=260 Participants Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.	US Licensed Vaccine - Male Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	US Licensed Vaccine - Female Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Non Solicited Adverse Events Subjects with at least 1 AE	45 participants	54 participants	—	—
Non Solicited Adverse Events Subjects with at least 1 treatment related AE	1 participants	5 participants	—	—

Adverse Events

Test Vaccine

Serious events: 0 serious events

Other events: 173 other events

Deaths: 0 deaths

US Licensed Vaccine

Serious events: 1 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Vaccine n=265 participants at risk NmVac4-A/C/Y/W-135-DT™ conjugate vaccine	US Licensed Vaccine n=260 participants at risk Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Nervous system disorders Cerebrovascular Accident	0.00% 0/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	0.38% 1/260 • Number of events 1 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Investigations Blood Creatinine Increased	0.00% 0/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	0.38% 1/260 • Number of events 1 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Investigations Glomerular Filtration Rate Decreased	0.00% 0/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	0.38% 1/260 • Number of events 1 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.

Other adverse events

Other adverse events
Measure	Test Vaccine n=265 participants at risk NmVac4-A/C/Y/W-135-DT™ conjugate vaccine	US Licensed Vaccine n=260 participants at risk Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
General disorders Tenderness around injection site	50.6% 134/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	38.5% 100/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Pain around injection site	41.1% 109/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	33.1% 86/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 53/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	18.8% 49/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Nervous system disorders Headache	17.4% 46/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	15.4% 40/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Fatigue	16.2% 43/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	16.2% 42/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Hardness around injection site	14.0% 37/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	10.0% 26/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Swelling around injection site	13.2% 35/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	8.8% 23/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Malaise	9.1% 24/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	10.0% 26/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Gastrointestinal disorders Diarrhea	8.3% 22/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	7.7% 20/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 21/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	8.1% 21/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Gastrointestinal disorders Nausea	9.4% 25/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	5.8% 15/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
General disorders Chills	7.2% 19/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	5.4% 14/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Metabolism and nutrition disorders Anorexia	6.8% 18/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	4.6% 12/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.
Investigations Blood Pressure Systolic Increased	6.0% 16/265 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.	4.6% 12/260 • Solicited AEs: vaccination day and 7 days following vaccination (participant diary cards, Outcome 2). AEs were also collected at each visit (4 weeks) and by phone calls 2-3 day following vaccination and at 6 months following vaccination (Outcome 3). Methods: standard questionnaire, investigator assessment, laboratory testing, scheduled telephone calls. Solicited AEs (secondary outcome 2) and non solicited AEs (secondary outcome 3) are included in the other adverse event totals. All AEs meeting the 4% threshold except increased blood pressure were solicited AEs from diary cards.

Additional Information

Regulatory Affairs Director

JN-International Medical Corporation

Phone: 4028843477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All abstracts, presentations or manuscripts, and any data analyses conducted independently by the Investigator must be submitted in advance to the sponsor for review and approval. The sponsor will not unreasonably withhold publication of study findings. The objective of this policy is to ensure consistency between data filed with a regulatory authority and those appearing in the publication.
Publication restrictions are in place

Restriction type: OTHER