Meningitis, Meningococcal
Conditions
Keywords
Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X
Brief summary
Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet. Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5). The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues. This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®). Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose. The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
Interventions
BIOLOGICALNon-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.
BIOLOGICALAdjuvanted 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
BIOLOGICALMenactra
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.
Sponsors
PATH
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation. The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.
Eligibility
Sex/Gender
ALL
Age
12 Months to 16 Months
Healthy volunteers
Yes
Inclusion criteria
* Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age); * For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements; * Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits); * Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. * Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)
Exclusion criteria
* History of any meningococcal vaccine administration. * Current or previous, confirmed or suspected disease caused by N. meningitidis. * Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment. * History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197). * Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination. * Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions). * Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw. * Severe acute malnutrition. * A family history of congenital or hereditary immunodeficiency. * History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection. * Major congenital defects. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed). * Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period. * Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination. * Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study. * Malaria infection as confirmed by a Rapid Diagnostic Test. * Individuals who are close family members of individuals conducting this study. * Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment. * Have received systemic antibiotic treatment within 3 days prior to enrolment. * Non-residence in the study area or intent to move out within six months. * Any condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe Solicited Adverse Event | 7 days post each vaccination | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 168 Days | SAEs reported during the entire study period |
| Seroprotective rSBA Titres | 112 days | 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) |
| Long Term Protective rSBA Titres | 112 days | 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 |
| Other Adverse Events | 168 Days | AEs leading to premature withdrawal during the entire study period; |
| Geometric Mean of rSBA Titres | 112 Days | rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112 |
| Solicited Reactions | 7 days post each vaccination | Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90); |
| Adverse Events | 112 Days | Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111); |
| Rise in rSBA Titres | 112 days | 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 |
Countries
Mali
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 149 |
| 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 | 150 |
| 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. | 76 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 4 | 3 | 3 |
| Overall Study | Subject discontinued due to travel | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject prior to initial vaccination | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Age, Continuous | 12.1 Months STANDARD_DEVIATION 0.6 | 12.1 Months STANDARD_DEVIATION 0.53 | 12.1 Months STANDARD_DEVIATION 0.44 | 12.1 Months STANDARD_DEVIATION 0.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 150 Participants | 76 Participants | 375 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Heart Rate (beats/min) | 110.8 Beats/minute STANDARD_DEVIATION 5.8 | 111.3 Beats/minute STANDARD_DEVIATION 5.74 | 110.8 Beats/minute STANDARD_DEVIATION 6.09 | 111.0 Beats/minute STANDARD_DEVIATION 5.83 |
| Length (cm) | 72.94 centimeters STANDARD_DEVIATION 2.533 | 73.03 centimeters STANDARD_DEVIATION 2.858 | 72.59 centimeters STANDARD_DEVIATION 2.46 | 72.91 centimeters STANDARD_DEVIATION 2.652 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 149 Participants | 150 Participants | 76 Participants | 375 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Respiratory Rate (breaths per minute) | 31.8 Breaths per minute STANDARD_DEVIATION 3 | 31.7 Breaths per minute STANDARD_DEVIATION 2.67 | 32.6 Breaths per minute STANDARD_DEVIATION 3.05 | 31.9 Breaths per minute STANDARD_DEVIATION 2.89 |
| Sex: Female, Male Female | 73 Participants | 68 Participants | 36 Participants | 177 Participants |
| Sex: Female, Male Male | 76 Participants | 82 Participants | 40 Participants | 198 Participants |
| Temperature (°C) | 36.25 Celsius STANDARD_DEVIATION 0.266 | 36.24 Celsius STANDARD_DEVIATION 0.299 | 36.24 Celsius STANDARD_DEVIATION 0.27 | 36.25 Celsius STANDARD_DEVIATION 0.279 |
| Weight (kg) | 8.81 kilograms STANDARD_DEVIATION 1.002 | 8.89 kilograms STANDARD_DEVIATION 1.14 | 8.77 kilograms STANDARD_DEVIATION 1.007 | 8.83 kilograms STANDARD_DEVIATION 1.059 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 149 | 1 / 150 | 0 / 76 | 0 / 144 | 0 / 145 | 1 / 73 |
| other Total, other adverse events | 41 / 149 | 44 / 150 | 25 / 76 | 24 / 144 | 17 / 145 | 16 / 73 |
| serious Total, serious adverse events | 1 / 149 | 1 / 150 | 0 / 76 | 0 / 144 | 0 / 145 | 1 / 73 |
Outcome results
Primary
Severe Solicited Adverse Event
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)
Time frame: 7 days post each vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose | 0 participants |
| Adjuvanted Study Formulation NmCV-5 | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose | 0 participants |
| Non-adjuvanted Study Formulation NmCV-5 | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose | 0 participants |
| Non-adjuvanted Study Formulation NmCV-5 | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose | 0 participants |
| Menactra | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose | 0 participants |
| Menactra | Severe Solicited Adverse Event | Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose | 0 participants |
Secondary
Adverse Events
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
Time frame: 112 Days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one related Unsolicited AE | 2 Participants |
| Adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one Unsolicited AE | 37 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one related Unsolicited AE | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | At least one Unsolicited AE | 39 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
| Menactra | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Menactra | Adverse Events | At least one Unsolicited AE | 23 Participants |
| Menactra | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Menactra | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Menactra | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Menactra | Adverse Events | At least one related Unsolicited AE | 0 Participants |
| Menactra | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
| Menactra | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one Unsolicited AE | 23 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one related Unsolicited AE | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one Unsolicited AE | 17 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one related Unsolicited AE | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | At least one serious related unsolicited AE | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | Unsolicited AEs leading to Death | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | unsolicited AEs leading to hospitalization | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | At least one serious unsolicited AE | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | At least one related Unsolicited AE | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | At least one Unsolicited AE | 16 Participants |
| Menactra (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 Participants |
| Menactra (Days 84-90) | Adverse Events | Unsolicited AEs leading to withdrawal from Study | 0 Participants |
Secondary
Geometric Mean of rSBA Titres
rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Time frame: 112 Days
Population: Per protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 84 | 3511.3 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 112 | 1366.9 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 0 | 3.8 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 28 | 7548.3 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 0 | 2.8 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 112 | 6226.3 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 0 | 3.5 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 28 | 6533.4 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 112 | 3189.0 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 112 | 8035.8 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 84 | 2555.6 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 28 | 2366.2 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 0 | 2.2 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 84 | 1171.7 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 0 | 3.6 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 28 | 1143.9 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 84 | 4687.0 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 112 | 5363.2 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 84 | 436.8 Geometric Mean rSBA Titer |
| Adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 28 | 7732.2 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 28 | 3010.0 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 0 | 4.3 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 28 | 7368.8 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 84 | 4488.3 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup A Day 112 | 6166.7 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 0 | 2.0 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 28 | 1095.4 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 84 | 348.4 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup C Day 112 | 1393.4 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 0 | 2.5 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 28 | 5363.2 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 84 | 2222.6 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup W Day 112 | 7056.4 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 0 | 3.2 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 28 | 8152.7 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 84 | 3113.2 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup X Day 112 | 6286.6 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 0 | 4.1 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 84 | 1386.8 Geometric Mean rSBA Titer |
| Non-adjuvanted Study Formulation NmCV-5 | Geometric Mean of rSBA Titres | Serogroup Y Day 112 | 3266.7 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup A Day 28 | 3866.1 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup X Day 28 | 6.9 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup C Day 84 | 29.6 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup Y Day 112 | 1194.5 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup X Day 84 | 6.7 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup C Day 28 | 67.8 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup Y Day 84 | 426.4 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup X Day 112 | 11.6 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup C Day 0 | 2.0 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup A Day 0 | 4.4 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup Y Day 0 | 3.9 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup A Day 112 | 4871.0 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup W Day 84 | 483.3 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup W Day 28 | 1127.5 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup A Day 84 | 2786.9 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup W Day 112 | 2482.8 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup W Day 0 | 2.2 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup Y Day 28 | 676.9 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup X Day 0 | 3.2 Geometric Mean rSBA Titer |
| Menactra | Geometric Mean of rSBA Titres | Serogroup C Day 112 | 410.3 Geometric Mean rSBA Titer |
Secondary
Long Term Protective rSBA Titres
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
Time frame: 112 days
Population: Per Protocol Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 84 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 0 | 16 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 28 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 0 | 8 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 0 | 15 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 28 | 142 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 84 | 137 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 28 | 140 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 0 | 2 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 84 | 138 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 0 | 16 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 28 | 142 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 84 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 112 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 84 | 133 Participants |
| Adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 28 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 28 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 0 | 18 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 28 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 84 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup A Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 0 | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 28 | 140 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 84 | 131 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup C Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 0 | 5 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 28 | 141 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 84 | 139 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup W Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 0 | 12 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 28 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 84 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup X Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 0 | 21 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 84 | 141 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Long Term Protective rSBA Titres | Serogroup Y Day 112 | 144 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup A Day 28 | 71 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup X Day 28 | 15 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup C Day 84 | 26 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup Y Day 112 | 66 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup X Day 84 | 14 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup C Day 28 | 39 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup Y Day 84 | 60 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup X Day 112 | 22 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup C Day 0 | 0 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup A Day 0 | 10 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup Y Day 0 | 10 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup A Day 112 | 72 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup W Day 84 | 57 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup W Day 28 | 65 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup A Day 84 | 71 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup W Day 112 | 69 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup W Day 0 | 2 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup Y Day 28 | 64 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup X Day 0 | 6 Participants |
| Menactra | Long Term Protective rSBA Titres | Serogroup C Day 112 | 68 Participants |
Secondary
Other Adverse Events
AEs leading to premature withdrawal during the entire study period;
Time frame: 168 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Other Adverse Events | 1 Number of events |
| Non-adjuvanted Study Formulation NmCV-5 | Other Adverse Events | 1 Number of events |
| Menactra | Other Adverse Events | 1 Number of events |
Secondary
Rise in rSBA Titres
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
Time frame: 112 days
Population: Per protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup A: Day 28 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup A: Day 112 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup C: Day 28 | 141 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup C: Day 112 | 142 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup W: Day 28 | 140 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup W: Day 112 | 142 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup X: Day 28 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup X: Day 112 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup Y: Day 28 | 140 Participants |
| Adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup Y: Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup Y: Day 28 | 142 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup A: Day 28 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup W: Day 112 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup W: Day 28 | 140 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup A: Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup Y: Day 112 | 142 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup X: Day 112 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup C: Day 28 | 141 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup X: Day 28 | 142 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Rise in rSBA Titres | Serogroup C: Day 112 | 144 Participants |
| Menactra | Rise in rSBA Titres | Serogroup X: Day 112 | 19 Participants |
| Menactra | Rise in rSBA Titres | Serogroup C: Day 112 | 72 Participants |
| Menactra | Rise in rSBA Titres | Serogroup W: Day 28 | 65 Participants |
| Menactra | Rise in rSBA Titres | Serogroup W: Day 112 | 71 Participants |
| Menactra | Rise in rSBA Titres | Serogroup Y: Day 28 | 63 Participants |
| Menactra | Rise in rSBA Titres | Serogroup X: Day 28 | 12 Participants |
| Menactra | Rise in rSBA Titres | Serogroup A: Day 28 | 70 Participants |
| Menactra | Rise in rSBA Titres | Serogroup Y: Day 112 | 71 Participants |
| Menactra | Rise in rSBA Titres | Serogroup A: Day 112 | 71 Participants |
| Menactra | Rise in rSBA Titres | Serogroup C: Day 28 | 50 Participants |
Secondary
Serious Adverse Events
SAEs reported during the entire study period
Time frame: 168 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Serious Adverse Events | 1 Number of events |
| Non-adjuvanted Study Formulation NmCV-5 | Serious Adverse Events | 1 Number of events |
| Menactra | Serious Adverse Events | 1 Number of events |
Secondary
Seroprotective rSBA Titres
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)
Time frame: 112 days
Population: per protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 28 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 84 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 0 | 15 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 0 | 9 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 28 | 141 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 28 | 142 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 0 | 16 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 84 | 140 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 112 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 0 | 17 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 28 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 84 | 141 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 112 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 28 | 143 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 0 | 3 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 84 | 144 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 84 | 141 Participants |
| Adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 28 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 84 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 0 | 19 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 0 | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 28 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 84 | 139 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup C Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 0 | 6 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 28 | 141 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 84 | 142 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup W Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 0 | 12 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 28 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 84 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup X Day 112 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 0 | 21 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup A Day 28 | 144 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 84 | 143 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Seroprotective rSBA Titres | Serogroup Y Day 112 | 144 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup Y Day 28 | 64 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup X Day 28 | 15 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup C Day 28 | 56 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup A Day 84 | 71 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup X Day 84 | 14 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup C Day 0 | 0 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup Y Day 112 | 71 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup X Day 112 | 25 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup A Day 0 | 10 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup Y Day 84 | 65 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup W Day 28 | 65 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup Y Day 0 | 10 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup W Day 84 | 59 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup W Day 0 | 2 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup A Day 112 | 72 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup W Day 112 | 72 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup C Day 112 | 72 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup A Day 28 | 71 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup X Day 0 | 6 Participants |
| Menactra | Seroprotective rSBA Titres | Serogroup C Day 84 | 51 Participants |
Secondary
Solicited Reactions
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
Time frame: 7 days post each vaccination
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Swelling/Induration | 0 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Tenderness | 1 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Fever | 4 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Vomiting | 3 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Decrease eating | 4 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Drowsiness | 1 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Any Solicited Local AE | 1 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Number of subjects with any Solicited AE | 9 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Irritability | 1 Participants |
| Adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Any Solicited Systemic AE | 8 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Any Solicited Local AE | 2 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Number of subjects with any Solicited AE | 8 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Tenderness | 1 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Swelling/Induration | 1 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Any Solicited Systemic AE | 6 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Irritability | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Drowsiness | 0 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Decrease eating | 2 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Vomiting | 4 Participants |
| Non-adjuvanted Study Formulation NmCV-5 | Solicited Reactions | Fever | 2 Participants |
| Menactra | Solicited Reactions | Swelling/Induration | 0 Participants |
| Menactra | Solicited Reactions | Decrease eating | 2 Participants |
| Menactra | Solicited Reactions | Number of subjects with any Solicited AE | 5 Participants |
| Menactra | Solicited Reactions | Any Solicited Systemic AE | 3 Participants |
| Menactra | Solicited Reactions | Tenderness | 3 Participants |
| Menactra | Solicited Reactions | Any Solicited Local AE | 3 Participants |
| Menactra | Solicited Reactions | Irritability | 1 Participants |
| Menactra | Solicited Reactions | Vomiting | 0 Participants |
| Menactra | Solicited Reactions | Fever | 3 Participants |
| Menactra | Solicited Reactions | Drowsiness | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Drowsiness | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Decrease eating | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Any Solicited Local AE | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Fever | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Vomiting | 1 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Number of subjects with any Solicited AE | 1 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Irritability | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Any Solicited Systemic AE | 1 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Swelling/Induration | 0 Participants |
| Non-adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Tenderness | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Drowsiness | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Swelling/Induration | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Any Solicited Systemic AE | 2 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Irritability | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Number of subjects with any Solicited AE | 2 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Decrease eating | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Fever | 1 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Vomiting | 1 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Tenderness | 0 Participants |
| Adjuvanted NmCV-5 (Days 84-90) | Solicited Reactions | Any Solicited Local AE | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Irritability | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Fever | 2 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Any Solicited Local AE | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Tenderness | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Any Solicited Systemic AE | 2 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Drowsiness | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Swelling/Induration | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Decrease eating | 0 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Number of subjects with any Solicited AE | 2 Participants |
| Menactra (Days 84-90) | Solicited Reactions | Vomiting | 1 Participants |