Trial Outcomes & Findings for Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds (NCT NCT03295318)
NCT ID: NCT03295318
Last Updated: 2025-05-25
Results Overview
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
375 participants
Primary outcome timeframe
7 days post each vaccination
Results posted on
2025-05-25
Participant Flow
A total of 515 toddlers were consented to withhold Mali EPI MenAfriVac vaccination at 9 months and were invited to return at 12 months for a second consent and final eligibility assessment. Among these, 136 were subsequently not consented, of which 127 received MenAfriVac to align with their EPI schedule. 379 participants were subsequently consented and assessed for eligibility, of which 2 did not meet eligibility criteria and 1 withdrew consent prior to randomization, leading to 376 randomized.
Participant milestones
| Measure |
Non-adjuvanted Study Formulation NmCV-5
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted Study Formulation NmCV-5
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
76
|
|
Overall Study
Received First Vaccination
|
149
|
150
|
76
|
|
Overall Study
Received Second Vaccination
|
144
|
145
|
73
|
|
Overall Study
COMPLETED
|
144
|
145
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
Non-adjuvanted Study Formulation NmCV-5
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted Study Formulation NmCV-5
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject prior to initial vaccination
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
4
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Subject discontinued due to travel
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Baseline characteristics by cohort
| Measure |
Non-adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.1 Months
STANDARD_DEVIATION 0.60 • n=5 Participants
|
12.1 Months
STANDARD_DEVIATION 0.53 • n=7 Participants
|
12.1 Months
STANDARD_DEVIATION 0.44 • n=5 Participants
|
12.1 Months
STANDARD_DEVIATION 0.54 • n=4 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
149 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Length (cm)
|
72.94 centimeters
STANDARD_DEVIATION 2.533 • n=5 Participants
|
73.03 centimeters
STANDARD_DEVIATION 2.858 • n=7 Participants
|
72.59 centimeters
STANDARD_DEVIATION 2.460 • n=5 Participants
|
72.91 centimeters
STANDARD_DEVIATION 2.652 • n=4 Participants
|
|
Weight (kg)
|
8.81 kilograms
STANDARD_DEVIATION 1.002 • n=5 Participants
|
8.89 kilograms
STANDARD_DEVIATION 1.140 • n=7 Participants
|
8.77 kilograms
STANDARD_DEVIATION 1.007 • n=5 Participants
|
8.83 kilograms
STANDARD_DEVIATION 1.059 • n=4 Participants
|
|
Temperature (°C)
|
36.25 Celsius
STANDARD_DEVIATION 0.266 • n=5 Participants
|
36.24 Celsius
STANDARD_DEVIATION 0.299 • n=7 Participants
|
36.24 Celsius
STANDARD_DEVIATION 0.270 • n=5 Participants
|
36.25 Celsius
STANDARD_DEVIATION 0.279 • n=4 Participants
|
|
Heart Rate (beats/min)
|
110.8 Beats/minute
STANDARD_DEVIATION 5.80 • n=5 Participants
|
111.3 Beats/minute
STANDARD_DEVIATION 5.74 • n=7 Participants
|
110.8 Beats/minute
STANDARD_DEVIATION 6.09 • n=5 Participants
|
111.0 Beats/minute
STANDARD_DEVIATION 5.83 • n=4 Participants
|
|
Respiratory Rate (breaths per minute)
|
31.8 Breaths per minute
STANDARD_DEVIATION 3.00 • n=5 Participants
|
31.7 Breaths per minute
STANDARD_DEVIATION 2.67 • n=7 Participants
|
32.6 Breaths per minute
STANDARD_DEVIATION 3.05 • n=5 Participants
|
31.9 Breaths per minute
STANDARD_DEVIATION 2.89 • n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days post each vaccinationPopulation: Analysis population different for severe solicited AEs within 7 days after 2nd study vaccination, as number of subjects who received the 2nd dose was less than those that received the first dose. Reasons outlined in Participant Flow.
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Severe Solicited Adverse Event
Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose
|
0 participants
Interval 0.0 to 2.53
|
0 participants
Interval 0.0 to 2.51
|
0 participants
Interval 0.0 to 4.93
|
—
|
—
|
—
|
|
Severe Solicited Adverse Event
Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose
|
0 participants
Interval 0.0 to 2.45
|
0 participants
Interval 0.0 to 2.43
|
0 participants
Interval 0.0 to 4.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 daysPopulation: per protocol population
Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=72 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Seroprotective rSBA Titres
Serogroup W Day 28
|
142 Participants
|
141 Participants
|
65 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup W Day 84
|
140 Participants
|
142 Participants
|
59 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup Y Day 28
|
141 Participants
|
143 Participants
|
64 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup X Day 28
|
144 Participants
|
143 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup X Day 84
|
144 Participants
|
143 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup Y Day 84
|
141 Participants
|
143 Participants
|
65 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup Y Day 112
|
144 Participants
|
144 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup A Day 0
|
16 Participants
|
19 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup A Day 28
|
144 Participants
|
144 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup A Day 84
|
144 Participants
|
144 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup A Day 112
|
144 Participants
|
144 Participants
|
72 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup C Day 0
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup C Day 28
|
143 Participants
|
143 Participants
|
56 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup C Day 84
|
141 Participants
|
139 Participants
|
51 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup C Day 112
|
144 Participants
|
144 Participants
|
72 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup W Day 0
|
9 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup W Day 112
|
144 Participants
|
144 Participants
|
72 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup X Day 0
|
15 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup X Day 112
|
143 Participants
|
144 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Seroprotective rSBA Titres
Serogroup Y Day 0
|
17 Participants
|
21 Participants
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Per Protocol Population
Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=72 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Long Term Protective rSBA Titres
Serogroup A Day 0
|
16 Participants
|
18 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup A Day 28
|
144 Participants
|
144 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup A Day 84
|
144 Participants
|
143 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup A Day 112
|
144 Participants
|
144 Participants
|
72 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup C Day 0
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup C Day 28
|
142 Participants
|
140 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup C Day 84
|
133 Participants
|
131 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup C Day 112
|
144 Participants
|
144 Participants
|
68 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup W Day 0
|
8 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup W Day 28
|
142 Participants
|
141 Participants
|
65 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup W Day 84
|
137 Participants
|
139 Participants
|
57 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup W Day 112
|
144 Participants
|
144 Participants
|
69 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup X Day 0
|
15 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup X Day 28
|
144 Participants
|
143 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup X Day 84
|
144 Participants
|
143 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup X Day 112
|
143 Participants
|
144 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup Y Day 0
|
16 Participants
|
21 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup Y Day 28
|
140 Participants
|
143 Participants
|
64 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup Y Day 84
|
138 Participants
|
141 Participants
|
60 Participants
|
—
|
—
|
—
|
|
Long Term Protective rSBA Titres
Serogroup Y Day 112
|
144 Participants
|
144 Participants
|
66 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Per protocol population
Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112. * For subjects with a pre-vaccination rSBA titer \< 8, a post-vaccination titer of ≥ 32; * For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=72 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Rise in rSBA Titres
Serogroup C: Day 112
|
142 Participants
|
144 Participants
|
72 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup W: Day 112
|
142 Participants
|
143 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup A: Day 28
|
143 Participants
|
144 Participants
|
70 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup A: Day 112
|
143 Participants
|
144 Participants
|
71 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup C: Day 28
|
141 Participants
|
141 Participants
|
50 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup W: Day 28
|
140 Participants
|
140 Participants
|
65 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup X: Day 28
|
144 Participants
|
142 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup X: Day 112
|
143 Participants
|
143 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup Y: Day 28
|
140 Participants
|
142 Participants
|
63 Participants
|
—
|
—
|
—
|
|
Rise in rSBA Titres
Serogroup Y: Day 112
|
144 Participants
|
142 Participants
|
71 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 DaysPopulation: Per protocol population
rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=72 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Geometric Mean of rSBA Titres
Serogroup C Day 84
|
436.8 Geometric Mean rSBA Titer
Interval 342.33 to 557.34
|
348.4 Geometric Mean rSBA Titer
Interval 272.51 to 445.33
|
29.6 Geometric Mean rSBA Titer
Interval 18.73 to 46.87
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup C Day 112
|
1366.9 Geometric Mean rSBA Titer
Interval 1173.58 to 1592.01
|
1393.4 Geometric Mean rSBA Titer
Interval 1200.54 to 1617.35
|
410.3 Geometric Mean rSBA Titer
Interval 324.93 to 518.11
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup W Day 112
|
8035.8 Geometric Mean rSBA Titer
Interval 6255.62 to 10322.51
|
7056.4 Geometric Mean rSBA Titer
Interval 5622.17 to 8856.57
|
2482.8 Geometric Mean rSBA Titer
Interval 1567.27 to 3933.27
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup X Day 0
|
3.5 Geometric Mean rSBA Titer
Interval 2.7 to 4.61
|
3.2 Geometric Mean rSBA Titer
Interval 2.5 to 4.19
|
3.2 Geometric Mean rSBA Titer
Interval 2.21 to 4.66
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup A Day 0
|
3.8 Geometric Mean rSBA Titer
Interval 2.81 to 5.18
|
4.3 Geometric Mean rSBA Titer
Interval 3.08 to 5.89
|
4.4 Geometric Mean rSBA Titer
Interval 2.74 to 6.95
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup A Day 28
|
7732.2 Geometric Mean rSBA Titer
Interval 6462.42 to 9251.52
|
7368.8 Geometric Mean rSBA Titer
Interval 6210.8 to 8742.81
|
3866.1 Geometric Mean rSBA Titer
Interval 2841.91 to 5259.43
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup A Day 84
|
4687.0 Geometric Mean rSBA Titer
Interval 3919.72 to 5604.44
|
4488.3 Geometric Mean rSBA Titer
Interval 3600.74 to 5594.57
|
2786.9 Geometric Mean rSBA Titer
Interval 2003.18 to 3877.24
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup A Day 112
|
6226.3 Geometric Mean rSBA Titer
Interval 5435.42 to 7132.33
|
6166.7 Geometric Mean rSBA Titer
Interval 5375.47 to 7047.35
|
4871.0 Geometric Mean rSBA Titer
Interval 3833.59 to 6189.12
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup C Day 0
|
2.2 Geometric Mean rSBA Titer
Interval 1.97 to 2.37
|
2.0 Geometric Mean rSBA Titer
\*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.
|
2.0 Geometric Mean rSBA Titer
\*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup C Day 28
|
1143.9 Geometric Mean rSBA Titer
Interval 929.32 to 1407.98
|
1095.4 Geometric Mean rSBA Titer
Interval 877.66 to 1367.12
|
67.8 Geometric Mean rSBA Titer
Interval 39.69 to 115.84
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup W Day 0
|
2.8 Geometric Mean rSBA Titer
Interval 2.22 to 3.52
|
2.5 Geometric Mean rSBA Titer
Interval 2.09 to 2.91
|
2.2 Geometric Mean rSBA Titer
Interval 1.91 to 2.64
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup W Day 28
|
6533.4 Geometric Mean rSBA Titer
Interval 4868.0 to 8768.46
|
5363.2 Geometric Mean rSBA Titer
Interval 3927.83 to 7323.21
|
1127.5 Geometric Mean rSBA Titer
Interval 614.73 to 2067.93
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup W Day 84
|
2555.6 Geometric Mean rSBA Titer
Interval 1839.63 to 3550.22
|
2222.6 Geometric Mean rSBA Titer
Interval 1673.59 to 2951.8
|
483.3 Geometric Mean rSBA Titer
Interval 242.96 to 961.24
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup X Day 28
|
7548.3 Geometric Mean rSBA Titer
Interval 6442.99 to 8843.32
|
8152.7 Geometric Mean rSBA Titer
Interval 6717.91 to 9893.84
|
6.9 Geometric Mean rSBA Titer
Interval 3.82 to 12.56
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup X Day 84
|
3511.3 Geometric Mean rSBA Titer
Interval 2934.73 to 4201.08
|
3113.2 Geometric Mean rSBA Titer
Interval 2552.53 to 3796.93
|
6.7 Geometric Mean rSBA Titer
Interval 3.73 to 11.91
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup X Day 112
|
5363.2 Geometric Mean rSBA Titer
Interval 4523.3 to 6359.15
|
6286.6 Geometric Mean rSBA Titer
Interval 5515.16 to 7165.86
|
11.6 Geometric Mean rSBA Titer
Interval 6.35 to 21.34
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup Y Day 0
|
3.6 Geometric Mean rSBA Titer
Interval 2.74 to 4.64
|
4.1 Geometric Mean rSBA Titer
Interval 3.08 to 5.55
|
3.9 Geometric Mean rSBA Titer
Interval 2.63 to 5.86
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup Y Day 28
|
2366.2 Geometric Mean rSBA Titer
Interval 1837.37 to 3047.14
|
3010.0 Geometric Mean rSBA Titer
Interval 2490.61 to 3637.74
|
676.9 Geometric Mean rSBA Titer
Interval 392.43 to 1167.54
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup Y Day 84
|
1171.7 Geometric Mean rSBA Titer
Interval 891.95 to 1539.31
|
1386.8 Geometric Mean rSBA Titer
Interval 1129.1 to 1703.21
|
426.4 Geometric Mean rSBA Titer
Interval 252.21 to 720.93
|
—
|
—
|
—
|
|
Geometric Mean of rSBA Titres
Serogroup Y Day 112
|
3189.0 Geometric Mean rSBA Titer
Interval 2700.52 to 3765.84
|
3266.7 Geometric Mean rSBA Titer
Interval 2800.84 to 3810.01
|
1194.5 Geometric Mean rSBA Titer
Interval 809.0 to 1763.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post each vaccinationPopulation: Safety Population
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
n=145 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
n=73 Participants
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Solicited Reactions
Tenderness
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Swelling/Induration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Number of subjects with any Solicited AE
|
9 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Solicited Reactions
Any Solicited Local AE
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Any Solicited Systemic AE
|
8 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Solicited Reactions
Irritability
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Drowsiness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Decrease eating
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Solicited Reactions
Vomiting
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Solicited Reactions
Fever
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 112 DaysPopulation: Safety Population
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
n=144 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
n=145 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
n=73 Participants
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Adverse Events
At least one related Unsolicited AE
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
unsolicited AEs leading to hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
At least one Unsolicited AE
|
37 Participants
|
39 Participants
|
23 Participants
|
23 Participants
|
17 Participants
|
16 Participants
|
|
Adverse Events
At least one serious unsolicited AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
At least one serious related unsolicited AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Unsolicited AEs leading to withdrawal from Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Unsolicited AEs leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 168 DaysAEs leading to premature withdrawal during the entire study period;
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Other Adverse Events
|
1 Number of events
|
1 Number of events
|
1 Number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 168 DaysSAEs reported during the entire study period
Outcome measures
| Measure |
Adjuvanted Study Formulation NmCV-5
n=149 Participants
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Non-adjuvanted Study Formulation NmCV-5
n=150 Participants
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Menactra
n=76 Participants
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 (Days 84-90)
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra (Days 84-90)
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Serious Adverse Events
|
1 Number of events
|
1 Number of events
|
1 Number of events
|
—
|
—
|
—
|
Adverse Events
Non-adjuvanted NmCV-5 Dose 1
Serious events: 1 serious events
Other events: 41 other events
Deaths: 1 deaths
Adjuvanted NmCV-5 Dose 1
Serious events: 1 serious events
Other events: 44 other events
Deaths: 1 deaths
Menactra Dose 1
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Non-adjuvanted NmCV-5 Dose 2
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Adjuvanted NmCV-5 Dose 2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Menactra Dose 2
Serious events: 1 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Non-adjuvanted NmCV-5 Dose 1
n=149 participants at risk
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
First dose to be administered is 0.5 mL intramuscularly.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 Dose 1
n=150 participants at risk
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
First dose to be administered is 0.5 mL intramuscularly.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra Dose 1
n=76 participants at risk
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 Dose 2
n=144 participants at risk
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 Dose 2
n=145 participants at risk
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra Dose 2
n=73 participants at risk
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Escheria Sepsis
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.67%
1/150 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
1/73 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
Other adverse events
| Measure |
Non-adjuvanted NmCV-5 Dose 1
n=149 participants at risk
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
First dose to be administered is 0.5 mL intramuscularly.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 Dose 1
n=150 participants at risk
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
First dose to be administered is 0.5 mL intramuscularly.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra Dose 1
n=76 participants at risk
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
Non-adjuvanted NmCV-5 Dose 2
n=144 participants at risk
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1.
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
|
Adjuvanted NmCV-5 Dose 2
n=145 participants at risk
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1.
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
|
Menactra Dose 2
n=73 participants at risk
Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra.
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1.
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection Site Tenderness
|
0.67%
1/149 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.67%
1/150 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
3.9%
3/76 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Injection Site Swelling/Induration
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.67%
1/150 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Irritability
|
0.67%
1/149 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Drowsiness
|
0.67%
1/149 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Decrease Eating
|
2.7%
4/149 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
2/150 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.6%
2/76 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Vomiting
|
2.0%
3/149 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.7%
4/150 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/144 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/145 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
1/73 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
General disorders
Fever
|
2.7%
4/149 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
2/150 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
3.9%
3/76 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/145 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.7%
2/73 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
4/149 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
2/150 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
1/73 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Bronchitis
|
6.0%
9/149 • Number of events 9 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
3.3%
5/150 • Number of events 5 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
9.2%
7/76 • Number of events 7 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
4.9%
7/144 • Number of events 7 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.8%
4/145 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.7%
2/73 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Conjunctivitis
|
1.3%
2/149 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Ear Infection
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.67%
1/150 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Furuncle
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Gastroenteritis
|
3.4%
5/149 • Number of events 5 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
2/150 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.1%
3/144 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.1%
3/145 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
4.1%
3/73 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Impetigo
|
1.3%
2/149 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/144 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/145 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
1/73 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
6/149 • Number of events 6 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
6.7%
10/150 • Number of events 10 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
6.6%
5/76 • Number of events 5 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
4.9%
7/144 • Number of events 7 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/145 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
6.8%
5/73 • Number of events 5 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Pharyngitis
|
6.7%
10/149 • Number of events 10 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
7.3%
11/150 • Number of events 12 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
2.8%
4/144 • Number of events 4 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
3.4%
5/145 • Number of events 5 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
1/73 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Rhinitis
|
5.4%
8/149 • Number of events 8 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
7.3%
11/150 • Number of events 12 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
9.2%
7/76 • Number of events 8 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/144 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.4%
2/145 • Number of events 2 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
4.1%
3/73 • Number of events 3 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/145 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.67%
1/150 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
1.3%
1/76 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Cough
|
0.67%
1/149 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/144 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
|
Infections and infestations
Varicella
|
0.00%
0/149 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/150 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/76 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.69%
1/144 • Number of events 1 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/145 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
0.00%
0/73 • Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
|
Additional Information
Abhijeet Dharmadhikari
Serum Institute of India Pvt. Ltd.
Phone: +91-20-26602855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place