Trial Outcomes & Findings for Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults (NCT NCT02810340)
NCT ID: NCT02810340
Last Updated: 2021-06-09
Results Overview
Solicited reactions (reactogenicity) were collected following vaccination through Day 7. If a solicited sign or symptom had started during the seven days post-vaccination period and continued beyond Day 7, it was still assessed as a solicited reaction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
7 days
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
MCV-5 With Adjuvant
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
MCV-5 With Adjuvant
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Incarceration
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults
Baseline characteristics by cohort
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 6.38 • n=99 Participants
|
30.4 years
STANDARD_DEVIATION 7.23 • n=107 Participants
|
33.1 years
STANDARD_DEVIATION 7.43 • n=206 Participants
|
32.5 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Height
|
67.2 inches
STANDARD_DEVIATION 2.90 • n=99 Participants
|
66.8 inches
STANDARD_DEVIATION 2.88 • n=107 Participants
|
68.6 inches
STANDARD_DEVIATION 4.18 • n=206 Participants
|
67.5 inches
STANDARD_DEVIATION 3.41 • n=7 Participants
|
|
Weight
|
158.2 pounds
STANDARD_DEVIATION 24.56 • n=99 Participants
|
150.0 pounds
STANDARD_DEVIATION 26.87 • n=107 Participants
|
174.6 pounds
STANDARD_DEVIATION 27.58 • n=206 Participants
|
160.9 pounds
STANDARD_DEVIATION 27.90 • n=7 Participants
|
PRIMARY outcome
Timeframe: 7 daysSolicited reactions (reactogenicity) were collected following vaccination through Day 7. If a solicited sign or symptom had started during the seven days post-vaccination period and continued beyond Day 7, it was still assessed as a solicited reaction.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Pain at injection site
|
12 Participants
|
10 Participants
|
7 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Erythema at injection site
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Swelling at injection site
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Any local symptom
|
12 Participants
|
10 Participants
|
8 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Headache
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Fatigue/malaise
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Joint pain/arthralgia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Muscle pain/myalgia
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Diarrhea
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Anorexia
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Chills
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Vomiting
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Any systemic symptom
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number and Percentage of Participants Experiencing Solicited Events
Solicited AE: Any systemic or local symptom
|
13 Participants
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 28 daysAdverse events (AE) were collected through day 28. Safety clinical laboratory evaluations were performed at Screening and at Day 8 and included: hemoglobin (HgB), white blood cells (WBC), platelet counts, alanine transaminase (ALT), albumin, total bilirubin, and creatinine. In addition, screening laboratory tests included serum HCG pregnancy tests for females of childbearing potential only, and screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infection. AE severity was graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014, of the US National Institute of Health.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events, by Severity
Mild
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events, by Severity
Moderate
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events, by Severity
Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 180 daysSerious adverse events (AE) were collected 6 months post-immunization. Safety clinical laboratory evaluations were performed at Screening and at Day 8 and included: hemoglobin (HgB), white blood cells (WBC), platelet counts, alanine transaminase (ALT), albumin, total bilirubin, and creatinine. In addition, screening laboratory tests included serum HCG pregnancy tests for females of childbearing potential only, and screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infection.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number of Subjects Experiencing Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysDefined as a ≥4-fold increase in post-immunization rabbit complement serum bactericidal activity (rSBA) titer between baseline and 28 days post-vaccination. The rSBA assay (previously validated for serogroups A, C, Y, and W) was performed at the Vaccine Evaluation Unit at Public Health England (PHE) in Manchester, United Kingdom.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies
Meningococcal Polysaccharide A
|
17 Participants
|
14 Participants
|
16 Participants
|
|
Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies
Meningococcal Polysaccharide C
|
19 Participants
|
20 Participants
|
17 Participants
|
|
Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies
Meningococcal Polysaccharide Y
|
19 Participants
|
19 Participants
|
15 Participants
|
|
Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies
Meningococcal Polysaccharide W
|
20 Participants
|
19 Participants
|
16 Participants
|
|
Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies
Meningococcal Polysaccharide X
|
19 Participants
|
17 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29Seroprotection defined as a titer ≥1:8 in post-immunization rabbit complement serum bactericidal activity (rSBA) titer between baseline and 28 days post-vaccination. The rSBA assay (previously validated for serogroups A, C, Y, and W) was performed at the Vaccine Evaluation Unit at Public Health England (PHE) in Manchester, United Kingdom.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide A: Baseline
|
15 Participants
|
17 Participants
|
10 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide A: Day 29
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide C: Baseline
|
9 Participants
|
3 Participants
|
4 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide C: Day 29
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Baseline
|
6 Participants
|
9 Participants
|
12 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Day 29
|
19 Participants
|
20 Participants
|
20 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide W: Baseline
|
5 Participants
|
9 Participants
|
8 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide W: Day 29
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide X: Baseline
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days
Meningococcal Polysaccharide X: Day 29
|
19 Participants
|
20 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29Seroprotection defined as a titer ≥1:128 in post-immunization rabbit complement serum bactericidal activity (rSBA) titer between baseline and 28 days post-vaccination. The rSBA assay (previously validated for serogroups A, C, Y, and W) was performed at the Vaccine Evaluation Unit at Public Health England (PHE) in Manchester, United Kingdom.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide A: Baseline
|
15 Participants
|
17 Participants
|
10 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide A: Day 29
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide C: Baseline
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide C: Day 29
|
19 Participants
|
20 Participants
|
17 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Baseline
|
6 Participants
|
9 Participants
|
12 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Day 29
|
19 Participants
|
20 Participants
|
20 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide W: Baseline
|
5 Participants
|
9 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide W: Day 29
|
20 Participants
|
20 Participants
|
18 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide X: Baseline
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days
Meningococcal Polysaccharide X: Day 29
|
19 Participants
|
20 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29Measured with rabbit complement serum bactericidal activity (rSBA) assay at baseline and 28 days post-vaccination. The rSBA assay (previously validated for serogroups A, C, Y, and W) was performed at the Vaccine Evaluation Unit at Public Health England (PHE) in Manchester, United Kingdom.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide A: Baseline
|
187 titer
Interval 49.6 to 708.0
|
350 titer
Interval 119.0 to 1025.0
|
33.1 titer
Interval 8.42 to 130.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide A: Day 29
|
6889 titer
Interval 3767.0 to 12596.0
|
5595 titer
Interval 3324.0 to 9418.0
|
3214 titer
Interval 1978.0 to 5222.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide C: Baseline
|
9.85 titer
Interval 3.77 to 25.7
|
4.29 titer
Interval 2.01 to 9.15
|
5.66 titer
Interval 2.15 to 14.9
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide C: Day 29
|
4096 titer
Interval 1720.0 to 9756.0
|
6208 titer
Interval 3579.0 to 10771.0
|
388 titer
Interval 139.0 to 1085.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Baseline
|
10.2 titer
Interval 3.03 to 34.4
|
24.3 titer
Interval 6.16 to 95.4
|
53.8 titer
Interval 14.2 to 204.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide Y: Day 29
|
4545 titer
Interval 1700.0 to 12149.0
|
9410 titer
Interval 4935.0 to 17942.0
|
2353 titer
Interval 1302.0 to 4251.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide W: Baseline
|
8.00 titer
Interval 2.44 to 26.2
|
26.9 titer
Interval 6.19 to 117.0
|
13.9 titer
Interval 4.16 to 46.6
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide W: Day 29
|
8192 titer
Interval 3439.0 to 19513.0
|
11191 titer
Interval 6720.0 to 18635.0
|
1261 titer
Interval 388.0 to 4091.0
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide X: Baseline
|
6.28 titer
Interval 2.44 to 16.1
|
5.28 titer
Interval 1.89 to 14.8
|
3.36 titer
Interval 1.76 to 6.43
|
|
Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days
Meningococcal Polysaccharide X: Day 29
|
1351 titer
Interval 577.0 to 3165.0
|
1607 titer
Interval 892.0 to 2895.0
|
3.14 titer
Interval 1.73 to 5.71
|
SECONDARY outcome
Timeframe: 28 daysMeasured with rabbit complement serum bactericidal activity (rSBA) assay at baseline and 28 days post-vaccination. The rSBA assay (previously validated for serogroups A, C, Y, and W) was performed at the Vaccine Evaluation Unit at Public Health England (PHE) in Manchester, United Kingdom.
Outcome measures
| Measure |
MCV-5 With Adjuvant
n=20 Participants
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 Participants
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 Participants
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers
Meningococcal Polysaccharide A
|
36.8 fold change
Interval 9.97 to 135.0
|
16.0 fold change
Interval 5.74 to 44.6
|
97.0 fold change
Interval 22.7 to 414.0
|
|
Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers
Meningococcal Polysaccharide C
|
416 fold change
Interval 125.0 to 1381.0
|
1448 fold change
Interval 507.0 to 4138.0
|
68.6 fold change
Interval 20.2 to 233.0
|
|
Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers
Meningococcal Polysaccharide Y
|
446 fold change
Interval 127.0 to 1560.0
|
388 fold change
Interval 77.7 to 1937.0
|
43.7 fold change
Interval 11.7 to 164.0
|
|
Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers
Meningococcal Polysaccharide W
|
1024 fold change
Interval 359.0 to 2918.0
|
416 fold change
Interval 94.5 to 1829.0
|
90.5 fold change
Interval 20.7 to 396.0
|
|
Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers
Meningococcal Polysaccharide X
|
215 fold change
Interval 66.1 to 701.0
|
304 fold change
Interval 90.1 to 1029.0
|
0.93 fold change
Interval 0.49 to 1.78
|
Adverse Events
MCV-5 With Adjuvant
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
MCV-5 Without Adjuvant
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Menactra®
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MCV-5 With Adjuvant
n=20 participants at risk
Received a single intramuscular injection of Adjuvanted MCV-5.
Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
|
MCV-5 Without Adjuvant
n=20 participants at risk
Received a single intramuscular injection of Non-Adjuvanted MCV-5.
Non-Adjuvanted MCV-5: Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
|
Menactra®
n=20 participants at risk
Received a single intramuscular injection of Menactra.
Menactra®: Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Number of events 3 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
10.0%
2/20 • Number of events 2 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Axillary pain
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 3 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
15.0%
3/20 • Number of events 3 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
10.0%
2/20 • Number of events 2 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Injection site discolouration
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Injection site pain
|
60.0%
12/20 • Number of events 12 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
50.0%
10/20 • Number of events 10 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
35.0%
7/20 • Number of events 7 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Injection site pruritus
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
General disorders
Injection site swelling
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Infections and infestations
Bacterial vaginosis
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
10.0%
2/20 • Number of events 2 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
10.0%
2/20 • Number of events 2 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
5.0%
1/20 • Number of events 1 • 7 days for solicited adverse events; 28 days for unsolicited non-serious adverse events; 180 days for serious adverse events.
No deaths and no serious adverse events were reported in this study. The Other Adverse Events table includes only unsolicited adverse events reporting because per study statistical analysis plan, unsolicited adverse events and solicited adverse events were presented separately. For a complete count of the solicited events, please refer to primary outcome safety tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place