Meningitis
Conditions
Keywords
vaccine, meningococcal, Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X
Brief summary
Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.
Detailed description
Meningococcal meningitis, caused by invasive strains of Neisseria meningitidis, is a major public health concern because of its considerable morbidity and mortality in sub-Saharan Africa. Case fatality during meningococcal meningitis epidemics can surpass 15%, and rates of permanent sequelae among meningitis survivors in Africa are twice as high as they are in high income countries. Because of the fulminant clinical course of invasive bacterial meningitis and difficulties in access to care in the African meningitis belt, prevention by vaccination is the optimal way to reduce meningococcal meningitis morbidity and mortality. Before 2010, serogroup A meningococcal strains were routinely responsible for the majority (70-96%) of invasive meningococcal disease in sub-Saharan Africa. And annual epidemic could be associated with an incidence of meningococcal disease which could range between 100-1000 cases per 100,000 persons in any given year. Progressive introduction of MenAfriVac since 2010 has resulted in a substantial reduction in cases of serogroup A meningococcal disease. However, regular large-scale epidemics due to serogroups C, W and X remain common in the African meningitis belt. An affordable and scalable pentavalent meningococcal conjugate vaccine (NmCV-5) has been developed by Serum Institute of India Pvt. Ltd. (SIIPL), the manufacturer of MenAfriVac. NmCV-5 is designed to protect against serogroups A, C, W, Y and X. The immediate goal for the clinical development of NmCV-5 is for WHO Pre-Qualification (WHO-PQ), to enable the vaccine to be used in the Meningitis Belt of sub-Saharan Africa. This trial will evaluate a single dose of NmCV-5 administered at either 9 months or 15 months of age, time points in the Expanded Program on Immunization (EPI) schedule when meningococcal vaccine is most likely to be administered. Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants aged 9 months (eligibility 9-11 months) and randomized to the 9-month age group will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT. Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months (eligibility 15-17 months) and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT. "Enhanced" EPI vaccines will be co-administered and will consist of 2-doses of a measles-containing vaccine administered at 9 months and 15 months and a single dose of yellow fever vaccine administered at 9 months. This study protocol is designed to provide evidence that concomitant vaccination with NmCV-5 will not significantly affect the immune responses of infants to their normally scheduled EPI vaccines. This study has been specifically designed to provide information at two distinct timepoints, 9 months and 15 months. The current Mali EPI schedule consists of a measles only vaccine, yellow fever vaccine, and MenA vaccine at 9 months of age; there is no 15 months of age EPI vaccine visit and typically only a single dose of a measles-containing vaccine is administered. However, to satisfy the conditions for WHO-PQ, study participants will receive two doses of a measles-containing vaccine, at 9-months and 15-months. Furthermore, the noninferiority evaluation must include an assessment of the rubella vaccine responses. These modifications to the standard Malian EPI schedule provide a level-of-care that is higher than the current standard-of-care for the general population. Within the context of this study, the researchers will refer to this as an "enhanced" EPI schedule.
Interventions
BIOLOGICALNmCV-5
NmCV-5 is a pentavalent meningococcal (A, C, Y, W, X) polysaccharideconjugate vaccine composed of capsularpolysaccharides (PS) from Neisseria meningitidis serogroups A, C, Y, W, and X individually conjugated to a protein carrier, either mutant diphtheria toxoid (CRM197) or tetanus toxoid (TT).
BIOLOGICALMenACWY-TT
MenACWY-TT (the comparator meningococcal vaccine) is a WHO-PQ quadrivalent meningococcal (A, C, Y, W) polysaccharide-conjugate vaccine manufactured by Pfizer.
Sponsors
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 11 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male and female children between 9 months and 11 months old inclusive. 2. Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements. 3. The investigator believes that their parent(s)/guardian(s) will be available for all the subjects visits and will comply with the requirements of the protocol (e.g., timely reporting of adverse events). 4. Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator. 5. Individual has completed their local infant EPI vaccines, not including 9-month EPI vaccines (at the 9-month visit) or 15- month EPI vaccines (at the 15-month visit). A birth dose of oral polio vaccine is not required.
Exclusion criteria
1. History of receipt of any meningococcal vaccine. 2. Has received a measles-containing vaccine. 3. Current or previous, confirm or suspected disease caused by N. meningitidis. 4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment or study vaccination (for the 15-month age group). 5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and mutant diphtheria toxoid (CRM197). 6. Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination. 7. Any confirmed or suspected condition with impaired or altered function of the immune system (e.g., immunodeficiency, autoimmune conditions, malnutrition). 8. Have any bleeding disorder which is considered a contraindication to intramuscular injection or blood draw. 9. Severe acute malnutrition. Note: a weight-for-length Z-score of less than -3 satisfies this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: The immune response to meningitis serogroup "S" at Day 29 elicited by one dose of NmCV-5 is inferior to the immune response elicited by one dose of MenACWY-TT. Alternative hypothesis: The immune response to meningitis serogroup "S" at Day 29 elicited by one dose of NmCV-5 is non-inferior, by a pre-specified margin, to the immune response elicited by one dose of MenACWY-TT, where "S" denotes one of the meningitis serogroups: A, C, W or Y. Endpoints are the seroprotective response at Day 29 to serogroups A, C, W and Y in the NmCV-5 arm and seroprotective response at Day 29 to serogroups A, C, W and Y in the MenACWY-TT arm with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100). |
| Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: At Day 29, the immune response to meningitis serogroup X elicited by one dose of NmCV-5 is inferior to the lowest immune response (among meningitis serogroups A, C, W or Y) elicited by one dose of MenACWY-TT. Alternative hypothesis: At Day 29, the immune response to meningitis serogroup X elicited by one dose of NmCV-5 is non-inferior, by a pre-specified margin, to the lowest immune response (among meningitis serogroups A, C, W or Y) elicited by one dose of MenACWY-TT. Endpoints are the seroprotective response to serogroup X in the NmCV-5 arm and the minimum seroprotective response among serogroups A, C, W and Y in the MenACWY-TT arm at Day 29 with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months). Proportions and difference in proportions are reported as percentages (number of infants per 100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAE) | Measured from time of meningococcal vaccination to Study Day 181 or early study termination, whichever is earlier. Follow-up time to Study Day 181 visit was a mean (s.d.) of 180.8 (3.0) days. | To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all Serious Adverse Events (SAE) occurring during the first 6 months of the follow-up period after meningococcal vaccination are reported. Endpoints are the number of participants with unsolicited adverse events that are reported as Serious Adverse Events (SAEs) according to ICH/GCP guidelines or the study protocol collected from the time of Step 2 randomization and vaccination and with date of event onset up to and including Study Day 181. |
| Number of Participants With Solicited Adverse Events (Reactogenicity) | Measured from about 30 minutes after meningococcal vaccination to Study Day 8 (7 days) for all participants. | To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all solicited AEs occurring during a 7-day follow-up period after meningococcal vaccination are reported. Solicited AEs include injection site (local) events (erythema/redness, induration/swelling, pain and/or tenderness) and systemic events (irritability, drowsiness/lethargy, decrease eating/anorexia, vomiting, fever (axillary), and feverish). Endpoints are the number of participants with solicited adverse events collected from about 30 minutes after meningococcal vaccination to Study Day 8 (7 days after vaccination). NOTE: Capture of data for symptom Feverish began on June 15, 2022, so some participants were not assessed for this symptom. Also, Fever (Axillary) is objectively measured by oral temperature and Feverish is a subjective observation from a parent who feels their infant has a raised temperature but not verified by thermometer. |
| Number of Participants With Unsolicited Adverse Events | Measured from time of meningococcal vaccination to Study Day 29 (28 days) for all participants. | To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all unsolicited AEs occurring through 28 days after meningococcal vaccination are reported. Unsolicited AEs include AEs reported in scheduled or interim (unscheduled) visits after receipt of meningitis vaccination and with date of onset up to and including Study Day 29. Endpoints are the number of participants reporting at least one unsolicited adverse event (overall and by MedDRA preferred term). |
| Number of Participants With Seroprotection for Meningitis Serogroup X | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: The immune response to meningitis serogroup X at Day 29 elicited by one dose of NmCV-5 is not superior to the immune response elicited by one dose of MenACWY-TT, Alternative hypothesis: The immune response to meningitis serogroup X at Day 29 elicited by one dose of NmCV-5 is superior, by a pre-specified margin, to the immune response elicited by one dose of MenACWY-TT. Endpoints are the seroprotective response to serogroup X in the NmCV-5 arm at Day 29 and the seroprotective response defined to serogroup X in the MenACWY-TT arm at Day 29 with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Superiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100). |
| Number of Participants With Seropositive Response to Measles Vaccine | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: The immune response to measles at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to measles at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seropositive responses to measles vaccine at Day 29 post vaccination, defined as anti-measles IgG concentration \>200 mIU/mL. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100). |
| Number of Participants With Seropositive Response to Rubella Vaccine | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: The immune response to rubella at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to rubella at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seropositive responses to rubella vaccine at Day 29 post vaccination, defined as anti-rubella IgG concentration \>20 IU/mL. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100). |
| Number of Participants With Seroprotective Response to Yellow Fever Vaccine | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | Null hypothesis: The immune response to yellow fever at Day 29 elicited by the yellow fever vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the yellow fever vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to yellow fever at Day 29 elicited by the yellow fever vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the yellow fever vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seroprotective responses to yellow fever vaccine at Day 29 post vaccination, defined as yellow fever neutralizing antibody titers ≥10. Non-inferiority comparisons are made between study vaccination arms within the 9 months study age group only. Proportions and difference in proportions are reported as percentages (number of infants per 100). |
| Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | For each study age group (9 months and 15 months) and for each of the five serogroups (A, C, W, Y, and X), geometric means and 95% CIs of rSBA titers at Day 29 are calculated by study vaccination arm within each study age group, and the Geometric Mean Titer (GMT) Ratio of rSBA titers at Day 29 for NmCV-5 relative to MenACWY-TT will be estimated, along with 95% CIs. The point and interval estimates will be obtained from a back transformation of the estimated difference in means of the log-transformed rSBA titers. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29). |
| Seroresponse for Meningitis Serogroups A, C, W, Y and X | Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the number and proportion of participants with seroresponse in rSBA titers at Day 29 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and percentage of participants with seroresponse in rSBA titers to meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29), where seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the participant's pre-immunization (Baseline) rSBA titer was \< 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the participant's pre-immunization rSBA titer was ≥ 8. Seroresponse is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100). |
| Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the Geometric Mean Fold Rise (GMFR) from baseline to Day 29 of rSBA titers to meningococcal serogroups A, C, W, Y and X is estimated, with 95% CI. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X from samples collected at Visit 1 (Day 1) and Visit 3 (Day 29). The point and interval estimates will be obtained from a back transformation of the estimated mean difference of the log-transformed rSBA titers. |
| Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days. | To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 128 at Day 29 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 128 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100). |
Countries
Mali
Contacts
STUDY_CHAIRWilbur Chen, MD, MS
University of Maryland, Baltimore
STUDY_DIRECTORKaren Kotloff, MD
University of Maryland, Baltimore
Participant flow
Recruitment details
Participants were recruited in Mali, enrollment began March 24, 2022, and all follow up at Day 29 was complete by March 10, 2023.
Pre-assignment details
1331 participants were assessed for eligibility and 6 were ineligible and excluded. 1325 participants received step 1 randomization to Group 1 (meningococcal vaccination at 9 months of age, n=602) or Group 2 (meningococcal vaccination at 15 months of age, n=723). 1202 participants received step 2 randomization to meningococcal vaccine study arm, and 123 Group 2 participants were excluded due to lost to follow-up or ineligibility or Group 2 target (n=600) met.
Participants by arm
| Arm | Count |
|---|---|
| Vaccination at 9 Months of Age With NmCV-5 Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 9 months of age, while receiving concomitant EPI vaccines.
NmCV-5: NmCV-5 is a pentavalent meningococcal (A, C, Y, W, X) polysaccharideconjugate vaccine composed of capsularpolysaccharides (PS) from Neisseria meningitidis serogroups A, C, Y, W, and X individually conjugated to a protein carrier, either mutant diphtheria toxoid (CRM197) or tetanus toxoid (TT). | 400 |
| Vaccination at 9 Months of Age With MenACWY-TT Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 9 months of age, while receiving concomitant EPI vaccines.
MenACWY-TT: MenACWY-TT (the comparator meningococcal vaccine) is a WHO-PQ quadrivalent meningococcal (A, C, Y, W) polysaccharide-conjugate vaccine manufactured by Pfizer. | 200 |
| Vaccination at 15 Months of Age With NmCV-5 Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 15 months of age, while receiving concomitant EPI vaccines.
NmCV-5: NmCV-5 is a pentavalent meningococcal (A, C, Y, W, X) polysaccharideconjugate vaccine composed of capsularpolysaccharides (PS) from Neisseria meningitidis serogroups A, C, Y, W, and X individually conjugated to a protein carrier, either mutant diphtheria toxoid (CRM197) or tetanus toxoid (TT). | 400 |
| Vaccination at 15 Months of Age With MenACWY-TT Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 15 months of age, while receiving concomitant EPI vaccines.
MenACWY-TT: MenACWY-TT (the comparator meningococcal vaccine) is a WHO-PQ quadrivalent meningococcal (A, C, Y, W) polysaccharide-conjugate vaccine manufactured by Pfizer. | 200 |
| Total | 1,200 |
Baseline characteristics
| Characteristic | Vaccination at 9 Months of Age With NmCV-5 | Vaccination at 9 Months of Age With MenACWY-TT | Vaccination at 15 Months of Age With MenACWY-TT | Vaccination at 15 Months of Age With NmCV-5 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 9.3 months STANDARD_DEVIATION 0.5 | 9.3 months STANDARD_DEVIATION 0.5 | 9.2 months STANDARD_DEVIATION 0.5 | 9.3 months STANDARD_DEVIATION 0.5 | 9.3 months STANDARD_DEVIATION 0.5 |
| Participant Body Temperature | 36.0 Celcius STANDARD_DEVIATION 0.4 | 36.0 Celcius STANDARD_DEVIATION 0.4 | 36.1 Celcius STANDARD_DEVIATION 0.4 | 36.1 Celcius STANDARD_DEVIATION 0.4 | 36.0 Celcius STANDARD_DEVIATION 0.4 |
| Participant Heart Rate, Pulse | 112.6 beats/minute STANDARD_DEVIATION 4 | 112.8 beats/minute STANDARD_DEVIATION 4.3 | 112.2 beats/minute STANDARD_DEVIATION 3.9 | 111.8 beats/minute STANDARD_DEVIATION 3.7 | 112.3 beats/minute STANDARD_DEVIATION 3.9 |
| Participant Height/Length | 70.1 cm STANDARD_DEVIATION 2.4 | 70.2 cm STANDARD_DEVIATION 2.9 | 69.9 cm STANDARD_DEVIATION 2.5 | 70.0 cm STANDARD_DEVIATION 2.6 | 70.0 cm STANDARD_DEVIATION 2.6 |
| Participant Length-for-weight z-score | -0.4 z-score STANDARD_DEVIATION 1.1 | -0.5 z-score STANDARD_DEVIATION 1.1 | -0.5 z-score STANDARD_DEVIATION 1 | -0.4 z-score STANDARD_DEVIATION 1.1 | -0.4 z-score STANDARD_DEVIATION 1.1 |
| Participant Rate of Respiration | 25.4 breaths/minute STANDARD_DEVIATION 2.9 | 25.6 breaths/minute STANDARD_DEVIATION 2.7 | 25.2 breaths/minute STANDARD_DEVIATION 2.8 | 25.4 breaths/minute STANDARD_DEVIATION 2.8 | 25.4 breaths/minute STANDARD_DEVIATION 2.8 |
| Participant weight | 8.1 kg STANDARD_DEVIATION 1 | 8.0 kg STANDARD_DEVIATION 1.1 | 8.0 kg STANDARD_DEVIATION 0.9 | 8.1 kg STANDARD_DEVIATION 1 | 8.0 kg STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized African | 400 Participants | 200 Participants | 200 Participants | 400 Participants | 1200 Participants |
| Region of Enrollment Mali | 400 participants | 200 participants | 200 participants | 400 participants | 1200 participants |
| Sex: Female, Male Female | 203 Participants | 101 Participants | 108 Participants | 201 Participants | 613 Participants |
| Sex: Female, Male Male | 197 Participants | 99 Participants | 92 Participants | 199 Participants | 587 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 401 | 0 / 201 | 1 / 123 | 0 / 400 | 0 / 200 |
| other Total, other adverse events | 64 / 400 | 37 / 200 | 0 / 0 | 16 / 400 | 8 / 200 |
| serious Total, serious adverse events | 1 / 401 | 0 / 201 | 1 / 123 | 2 / 400 | 1 / 200 |
Outcome results
Primary
Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y
Null hypothesis: The immune response to meningitis serogroup S at Day 29 elicited by one dose of NmCV-5 is inferior to the immune response elicited by one dose of MenACWY-TT. Alternative hypothesis: The immune response to meningitis serogroup S at Day 29 elicited by one dose of NmCV-5 is non-inferior, by a pre-specified margin, to the immune response elicited by one dose of MenACWY-TT, where S denotes one of the meningitis serogroups: A, C, W or Y. Endpoints are the seroprotective response at Day 29 to serogroups A, C, W and Y in the NmCV-5 arm and seroprotective response at Day 29 to serogroups A, C, W and Y in the MenACWY-TT arm with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | No | 21 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | Yes | 360 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | Yes | 352 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | Yes | 369 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | No | 13 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | Yes | 373 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | No | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | No | 4 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | Yes | 191 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | Yes | 186 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | Yes | 190 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | Yes | 190 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | No | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | No | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | Yes | 366 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | No | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | Yes | 358 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | No | 9 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | Yes | 362 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | Yes | 364 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | No | 3 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | Yes | 179 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | No | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | No | 4 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup Y | Yes | 178 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup A | Yes | 180 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | No | 3 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup W | Yes | 179 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y | Participants with seroprotective response against meningococcal serogroup C | No | 3 Participants |
Comparison: For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-5.4, -0.4]
Comparison: For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-1, 2]
Comparison: For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-0.6, 3.7]
Comparison: For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-2.3, 1.9]
Comparison: For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-3.3, 2.5]
Comparison: For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-6.3, 0.8]
Comparison: For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-1.8, 3.5]
Comparison: For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [-0.6, 4.8]
Primary
Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT)
Null hypothesis: At Day 29, the immune response to meningitis serogroup X elicited by one dose of NmCV-5 is inferior to the lowest immune response (among meningitis serogroups A, C, W or Y) elicited by one dose of MenACWY-TT. Alternative hypothesis: At Day 29, the immune response to meningitis serogroup X elicited by one dose of NmCV-5 is non-inferior, by a pre-specified margin, to the lowest immune response (among meningitis serogroups A, C, W or Y) elicited by one dose of MenACWY-TT. Endpoints are the seroprotective response to serogroup X in the NmCV-5 arm and the minimum seroprotective response among serogroups A, C, W and Y in the MenACWY-TT arm at Day 29 with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months). Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) | Yes | 371 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) | Yes | 186 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) | No | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) | Yes | 366 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) | No | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) | No | 4 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) | Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) | Yes | 178 Participants |
Comparison: For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.95% CI: [0.3, 4.7]
Comparison: For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.95% CI: [0.004, 4.4]
Secondary
Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X
To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the Geometric Mean Fold Rise (GMFR) from baseline to Day 29 of rSBA titers to meningococcal serogroups A, C, W, Y and X is estimated, with 95% CI. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X from samples collected at Visit 1 (Day 1) and Visit 3 (Day 29). The point and interval estimates will be obtained from a back transformation of the estimated mean difference of the log-transformed rSBA titers.
Time frame: Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: Participants in the Baseline Immunogenicity Analysis Set include a subset of participants randomly selected for assessment of baseline rSBA titers from blood samples collected at Day 1 (pre-vaccination). This set includes up to 150 participants from Group 1 and 198 participants from Group 2 who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory for both the Day 1 and Day 29 visit samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 29 | 7111.4 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 1 | 2.2 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 29 | 633.0 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 1 | 2.2 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 29 | 6706.5 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 1 | 2.6 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 1 | 2.5 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 29 | 1908.2 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 29 | 2326.1 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 1 | 2.4 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 29 | 1602.2 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 1 | 2.5 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 1 | 3.3 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 29 | 8554.7 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 1 | 2.4 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 29 | 4801.2 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 1 | 2.4 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 29 | 3494.4 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 1 | 2.2 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 29 | 4.4 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 1 | 2.4 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 1 | 10.6 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 29 | 7770.2 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 29 | 647.6 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 1 | 5.7 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 29 | 3454.4 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 29 | 8687.6 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 1 | 6.2 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 1 | 2.2 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 29 | 13817.8 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 1 | 2.3 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 1 | 2.3 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 29 | 3083.1 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 1 | 8.3 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Day 29 | 1934.9 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Day 29 | 3226.5 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 1 | 8.2 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Day 1 | 5.4 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Day 29 | 7917.4 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean Fold Rise (GMFR) for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Day 29 | 16.2 rSBA titer |
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [1976.3, 3844.5]
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [1404, 4476.1]
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [709.8, 1958.6]
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [513.4, 2340.6]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [212.6, 392]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [385.5, 1111]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [213.9, 387.5]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [496.7, 1402.3]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [683.3, 1670.6]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [1224.7, 3051.1]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [2247.5, 4451.7]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [913.5, 2543]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [532.9, 1199.4]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [995.3, 2168.8]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [371.8, 811.8]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [309.2, 1335.9]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [2037.6, 3394.6]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [1.2, 3.4]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [905.2, 2262.9]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.95% CI: [0.9, 3.3]
Secondary
Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X
For each study age group (9 months and 15 months) and for each of the five serogroups (A, C, W, Y, and X), geometric means and 95% CIs of rSBA titers at Day 29 are calculated by study vaccination arm within each study age group, and the Geometric Mean Titer (GMT) Ratio of rSBA titers at Day 29 for NmCV-5 relative to MenACWY-TT will be estimated, along with 95% CIs. The point and interval estimates will be obtained from a back transformation of the estimated difference in means of the log-transformed rSBA titers. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup Y | 2086.4 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup C | 738.3 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup X | 7352.8 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup W | 2612.5 rSBA titer |
| Vaccination at 9 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup A | 8131.3 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup W | 2933.3 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup Y | 2798.2 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup X | 4.9 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup C | 1565.7 rSBA titer |
| Vaccination at 9 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup A | 7814.5 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup W | 7383.7 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup A | 13436.7 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup C | 807.1 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup Y | 3629.6 rSBA titer |
| Vaccination at 15 Months of Age With NmCV-5 | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup X | 9262.0 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup Y | 3598.5 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup C | 2103.3 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup A | 10942.0 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup W | 4733.8 rSBA titer |
| Vaccination at 15 Months of Age With MenACWY-TT | Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X | Serogroup X | 12.1 rSBA titer |
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.8, 1.3]
Comparison: For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [1, 1.6]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.4, 0.6]
Comparison: For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.3, 0.5]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.6, 1.3]
Comparison: For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [1.1, 2.1]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.6, 1]
Comparison: For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [0.8, 1.3]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [1169.5, 1952.4]
Comparison: For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.95% CI: [553.2, 1064.4]
Secondary
Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X
To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 128 at Day 29 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 128 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | No | 25 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | Yes | 348 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | No | 19 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | Yes | 356 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | Yes | 354 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | No | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | Yes | 372 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | No | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | Yes | 371 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | No | 17 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | Yes | 187 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | Yes | 191 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | No | 6 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | No | 4 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | Yes | 190 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | Yes | 29 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | No | 162 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | Yes | 185 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | No | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | No | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | No | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | Yes | 351 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | Yes | 364 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | No | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | Yes | 366 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | No | 16 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | Yes | 366 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | Yes | 362 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | Yes | 179 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | Yes | 178 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | Yes | 177 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup Y, Participants with rSBA titer ≥ 128 | No | 4 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | No | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | Yes | 51 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup A, Participants with rSBA titer ≥ 128 | Yes | 180 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup W, Participants with rSBA titer ≥ 128 | No | 5 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup X, Participants with rSBA titer ≥ 128 | No | 131 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With rSBA Titers ≥ 128 for Meningitis Serogroups A, C, W, Y and X | Serogroup C, Participants with rSBA titer ≥ 128 | No | 3 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAE)
To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all Serious Adverse Events (SAE) occurring during the first 6 months of the follow-up period after meningococcal vaccination are reported. Endpoints are the number of participants with unsolicited adverse events that are reported as Serious Adverse Events (SAEs) according to ICH/GCP guidelines or the study protocol collected from the time of Step 2 randomization and vaccination and with date of event onset up to and including Study Day 181.
Time frame: Measured from time of meningococcal vaccination to Study Day 181 or early study termination, whichever is earlier. Follow-up time to Study Day 181 visit was a mean (s.d.) of 180.8 (3.0) days.
Population: All participants included in the modified intent-to-treat (mITT) Analysis Set which includes all participants who were randomized at Step 1 and Step 2 and who received a study meningitis vaccine (NmCV-5 or MenACWY-TT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | Yes | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | No | 399 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | No | 400 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | Yes | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | No | 400 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | No | 399 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | No | 398 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | Yes | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | No | 399 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | Yes | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | No | 399 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | Yes | 2 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Gastroenteritis | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Malnutrition | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Participants experiencing SAE | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Serious Adverse Events (SAE) | Thermal burn | No | 199 Participants |
Secondary
Number of Participants With Seropositive Response to Measles Vaccine
Null hypothesis: The immune response to measles at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to measles at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seropositive responses to measles vaccine at Day 29 post vaccination, defined as anti-measles IgG concentration \>200 mIU/mL. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Measles Vaccine | Yes | 364 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Measles Vaccine | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Measles Vaccine | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Measles Vaccine | Yes | 187 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Measles Vaccine | Yes | 364 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Measles Vaccine | No | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Measles Vaccine | Yes | 176 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Measles Vaccine | No | 0 Participants |
Comparison: For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.95% CI: [-1, 2]
Comparison: For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.95% CI: [-1, 2.1]
Secondary
Number of Participants With Seropositive Response to Rubella Vaccine
Null hypothesis: The immune response to rubella at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to rubella at Day 29 elicited by the MR vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the MR vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seropositive responses to rubella vaccine at Day 29 post vaccination, defined as anti-rubella IgG concentration \>20 IU/mL. Non-inferiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Rubella Vaccine | Yes | 294 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Rubella Vaccine | No | 70 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Rubella Vaccine | No | 28 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Rubella Vaccine | Yes | 159 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Rubella Vaccine | Yes | 364 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seropositive Response to Rubella Vaccine | No | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Rubella Vaccine | Yes | 176 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seropositive Response to Rubella Vaccine | No | 0 Participants |
Comparison: For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.95% CI: [-10.5, 2.6]
Comparison: For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.95% CI: [-1, 2.1]
Secondary
Number of Participants With Seroprotection for Meningitis Serogroup X
Null hypothesis: The immune response to meningitis serogroup X at Day 29 elicited by one dose of NmCV-5 is not superior to the immune response elicited by one dose of MenACWY-TT, Alternative hypothesis: The immune response to meningitis serogroup X at Day 29 elicited by one dose of NmCV-5 is superior, by a pre-specified margin, to the immune response elicited by one dose of MenACWY-TT. Endpoints are the seroprotective response to serogroup X in the NmCV-5 arm at Day 29 and the seroprotective response defined to serogroup X in the MenACWY-TT arm at Day 29 with seroprotective response defined as serogroup specific rSBA antibody titers ≥ 8. Superiority comparisons are made between study vaccination arms within each study age group (9 months or 15 months of age). Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X | Yes | 371 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X | No | 158 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X | Yes | 33 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X | Yes | 366 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Seroprotection for Meningitis Serogroup X | No | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X | Yes | 57 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Seroprotection for Meningitis Serogroup X | No | 125 Participants |
Comparison: For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [76.4, 87.2]
Comparison: For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.95% CI: [61.3, 74.7]
Secondary
Number of Participants With Seroprotective Response to Yellow Fever Vaccine
Null hypothesis: The immune response to yellow fever at Day 29 elicited by the yellow fever vaccine when co-administered with one dose of NmCV-5 is inferior to the immune response elicited by the yellow fever vaccine when co-administered with one dose of MenACWY-TT. Alternative hypothesis: The immune response to yellow fever at Day 29 elicited by the yellow fever vaccine when co-administered with one dose of NmCV-5 is non inferior, by a pre-specified margin, to the immune response elicited by the yellow fever vaccine when co-administered with one dose of MenACWY-TT. Endpoints are the seroprotective responses to yellow fever vaccine at Day 29 post vaccination, defined as yellow fever neutralizing antibody titers ≥10. Non-inferiority comparisons are made between study vaccination arms within the 9 months study age group only. Proportions and difference in proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All Group 1 participants included in the Per Protocol (PP) Analysis Set which includes eligible participants receiving step 1 and 2 randomizations, the randomized meningococcal vaccination in the appropriate age group window with the scheduled EPI vaccinations, and who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotective Response to Yellow Fever Vaccine | Yes | 355 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Seroprotective Response to Yellow Fever Vaccine | No | 9 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotective Response to Yellow Fever Vaccine | Yes | 186 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Seroprotective Response to Yellow Fever Vaccine | No | 1 Participants |
Comparison: For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.95% CI: [-4.2, 0.6]
Secondary
Number of Participants With Solicited Adverse Events (Reactogenicity)
To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all solicited AEs occurring during a 7-day follow-up period after meningococcal vaccination are reported. Solicited AEs include injection site (local) events (erythema/redness, induration/swelling, pain and/or tenderness) and systemic events (irritability, drowsiness/lethargy, decrease eating/anorexia, vomiting, fever (axillary), and feverish). Endpoints are the number of participants with solicited adverse events collected from about 30 minutes after meningococcal vaccination to Study Day 8 (7 days after vaccination). NOTE: Capture of data for symptom Feverish began on June 15, 2022, so some participants were not assessed for this symptom. Also, Fever (Axillary) is objectively measured by oral temperature and Feverish is a subjective observation from a parent who feels their infant has a raised temperature but not verified by thermometer.
Time frame: Measured from about 30 minutes after meningococcal vaccination to Study Day 8 (7 days) for all participants.
Population: All participants included in the modified intent-to-treat (mITT) Analysis Set which includes all participants who were randomized at Step 1 and Step 2 and who received a study meningitis vaccine (NmCV-5 or MenACWY-TT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | No | 398 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Yes | 2 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | No | 352 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Yes | 250 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Yes | 60 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | No | 396 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | No | 340 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Not Evaluated | 212 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Yes | 17 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | No | 394 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | No | 147 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | No | 383 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Yes | 224 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Yes | 6 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | No | 162 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | No | 150 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Yes | 238 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Yes | 41 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Yes | 4 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | No | 176 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Yes | 48 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Yes | 4 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | No | 396 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | No | 399 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Yes | 31 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | No | 195 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Yes | 5 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | No | 169 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Yes | 3 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Yes | 3 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | No | 197 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | No | 63 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Yes | 120 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | No | 80 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Yes | 137 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | No | 197 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Yes | 32 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Not Evaluated | 107 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | No | 168 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Yes | 129 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | No | 73 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Yes | 5 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | No | 195 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | No | 71 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Yes | 20 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Yes | 2 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Not Evaluated | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | No | 198 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | No | 294 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Yes | 2 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | No | 398 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Yes | 106 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | No | 294 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Yes | 16 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | No | 384 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Yes | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | No | 397 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Yes | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | No | 397 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Yes | 4 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | No | 396 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Yes | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | No | 395 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Yes | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | No | 397 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Yes | 7 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | No | 393 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Yes | 115 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | No | 285 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Yes | 106 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | No | 198 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Yes | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Irritability | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | No | 198 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | No | 197 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a systemic solicited AE | Yes | 3 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | No | 156 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Feverish | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | No | 156 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Yes | 44 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | Yes | 45 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Pain and/or tenderness | Yes | 44 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Erythema/redness | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a solicited AE | No | 155 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Vomiting | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Induration/swelling | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Fever (axillary) | Yes | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Decrease eating/anorexia | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Drowsiness/lethargy | Not Evaluated | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Solicited Adverse Events (Reactogenicity) | Participants experiencing a local solicited AE | Not Evaluated | 0 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events
To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all unsolicited AEs occurring through 28 days after meningococcal vaccination are reported. Unsolicited AEs include AEs reported in scheduled or interim (unscheduled) visits after receipt of meningitis vaccination and with date of onset up to and including Study Day 29. Endpoints are the number of participants reporting at least one unsolicited adverse event (overall and by MedDRA preferred term).
Time frame: Measured from time of meningococcal vaccination to Study Day 29 (28 days) for all participants.
Population: All participants included in the modified intent-to-treat (mITT) Analysis Set which includes all participants who were randomized at Step 1 and Step 2 and who received a study meningitis vaccine (NmCV-5 or MenACWY-TT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | Yes | 64 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Rhinitis | Yes | 5 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Malaria | No | 399 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Bronchitis | Yes | 10 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otorrhoea | Yes | 2 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | Yes | 2 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | No | 398 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Malaria | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otitis media acute | No | 399 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otitis media acute | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Bronchitis | No | 390 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pyoderma | No | 391 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | Yes | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Rhinitis | No | 395 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | No | 400 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Allergic cough | Yes | 1 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pyoderma | Yes | 9 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Diarrhoea | Yes | 19 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Diarrhoea | No | 381 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pharyngitis | No | 391 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | Yes | 5 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | No | 395 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Allergic cough | No | 399 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pharyngitis | Yes | 9 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Impetigo | Yes | 4 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Impetigo | No | 396 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | No | 336 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otorrhoea | No | 398 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Rhinitis | Yes | 2 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Malaria | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otorrhoea | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pharyngitis | Yes | 5 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Malaria | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Impetigo | Yes | 4 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | No | 197 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Diarrhoea | Yes | 7 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | Yes | 2 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Bronchitis | Yes | 13 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otitis media acute | No | 199 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Allergic cough | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | No | 198 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pharyngitis | No | 195 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Allergic cough | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Diarrhoea | No | 193 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otitis media acute | Yes | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | No | 163 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pyoderma | No | 197 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Rhinitis | No | 198 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Bronchitis | No | 187 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | Yes | 37 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otorrhoea | No | 200 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Impetigo | No | 196 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | Yes | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | Yes | 3 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pyoderma | Yes | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | Yes | 16 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | No | 384 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Allergic cough | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Allergic cough | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Bronchitis | Yes | 4 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Bronchitis | No | 396 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | Yes | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | No | 399 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Diarrhoea | Yes | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Diarrhoea | No | 399 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | Yes | 4 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | No | 396 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Impetigo | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Impetigo | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Malaria | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Malaria | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otitis media acute | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otitis media acute | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otorrhoea | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Otorrhoea | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pharyngitis | Yes | 5 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pharyngitis | No | 395 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pyoderma | Yes | 0 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Pyoderma | No | 400 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Rhinitis | Yes | 2 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Number of Participants With Unsolicited Adverse Events | Rhinitis | No | 398 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Impetigo | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Impetigo | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Allergic cough | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otorrhoea | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Gastroenteritis | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Rhinitis | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pharyngitis | Yes | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Diarrhoea | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Diarrhoea | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Rhinitis | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pharyngitis | No | 198 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | No | 199 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Conjunctivitis | Yes | 1 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | No | 192 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pyoderma | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Bronchitis | No | 197 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Bronchitis | Yes | 3 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Participants experiencing an unsolicited AE | Yes | 8 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otitis media acute | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Pyoderma | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otitis media acute | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Malaria | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Malaria | Yes | 0 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Allergic cough | No | 200 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Number of Participants With Unsolicited Adverse Events | Otorrhoea | Yes | 0 Participants |
Secondary
Seroresponse for Meningitis Serogroups A, C, W, Y and X
To assess clinically significant immune response indicators elicited by a single dose of meningococcal vaccine, the number and proportion of participants with seroresponse in rSBA titers at Day 29 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and percentage of participants with seroresponse in rSBA titers to meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 3 (Study Day 29), where seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the participant's pre-immunization (Baseline) rSBA titer was \< 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the participant's pre-immunization rSBA titer was ≥ 8. Seroresponse is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.
Population: All participants included in the Baseline Immunogenicity Analysis Set which includes a subset of participants randomly selected for assessment of baseline rSBA titers from blood samples collected at Day 1 (pre-vaccination). This set includes up to 150 participants from Group 1 and 198 participants from Group 2 who had a blood specimen collected in the appropriate window around the Day 29 visit and a successful rSBA value provided by the laboratory for both the Day 1 and Day 29 visit samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | No | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | No | 4 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | No | 6 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | No | 0 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | Yes | 94 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | Yes | 98 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | Yes | 96 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | Yes | 97 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | No | 2 Participants |
| Vaccination at 9 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | Yes | 92 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | No | 41 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | Yes | 47 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | Yes | 47 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | No | 0 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | Yes | 48 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | Yes | 48 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | No | 1 Participants |
| Vaccination at 9 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | Yes | 7 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | Yes | 117 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | Yes | 116 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | No | 2 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | Yes | 112 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | No | 6 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | No | 3 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | No | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | Yes | 117 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | No | 1 Participants |
| Vaccination at 15 Months of Age With NmCV-5 | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | Yes | 115 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | Yes | 59 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | No | 3 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | Yes | 57 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | No | 4 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup C Seroresponse | Yes | 58 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup A Seroresponse | No | 4 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | No | 52 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup W Seroresponse | No | 2 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup X Seroresponse | Yes | 9 Participants |
| Vaccination at 15 Months of Age With MenACWY-TT | Seroresponse for Meningitis Serogroups A, C, W, Y and X | Participants with Serogroup Y Seroresponse | Yes | 57 Participants |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) at Study Day 181 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the Geometric Mean Fold Rise (GMFR) from baseline to Day 181 of rSBA titers to meningococcal serogroups A, C, W, Y and X is estimated, with 95% CI. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X from samples collected at Visit 1 (Day 1) and Visit 4 (Day 181). The point and interval estimates will be obtained from a back transformation of the estimated mean difference of the log-transformed rSBA titers.
Time frame: Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 181 visit. Follow-up time to Day 181 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Geometric Mean Fold Rise (GMFR) at Study Day 730 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the Geometric Mean Fold Rise (GMFR) from baseline to Day 730 of rSBA titers to meningococcal serogroups A, C, W, Y and X is estimated, with 95% CI. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X from samples collected at Visit 1 (Day 1) and Visit 5 (Day 730). The point and interval estimates will be obtained from a back transformation of the estimated mean difference of the log-transformed rSBA titers.
Time frame: Measured from time of blood sample collection just prior to meningococcal vaccination at Day 1 visit to blood sample collection at Day 730 visit. Follow-up time to Day 730 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Geometric Mean of rSBA Titers at Study Day 181 for Meningitis Serogroups A, C, W, Y and X
For each study age group (9 months and 15 months) and for each of the five serogroups (A, C, W, Y, and X), geometric means and 95% CIs of rSBA titers at Day 181 are calculated by study vaccination arm within each study age group. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 4 (Study Day 181).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 181 visit. Follow-up time to Day 181 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Geometric Mean of rSBA Titers at Study Day 730 for Meningitis Serogroups A, C, W, Y and X
For each study age group (9 months and 15 months) and for each of the five serogroups (A, C, W, Y, and X), geometric means and 95% CIs of rSBA titers at Day 730 are calculated by study vaccination arm within each study age group. Endpoints are the rSBA titer values for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 5 (Study Day 730).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 730 visit. Follow-up time to Day 730 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Number of Participants With rSBA Titers ≥ 128 at Study Day 181 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 128 at Day 181 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 128 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 4 (Study Day 181). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 181 visit. Follow-up time to Day 181 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Number of Participants With rSBA Titers ≥ 128 at Study Day 730 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 128 at Day 730 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 128 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 5 (Study Day 730). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 730 visit. Follow-up time to Day 730 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Number of Participants With rSBA Titers ≥ 8 at Study Day 181 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 8 at Day 181 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 8 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 4 (Study Day 181). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 181 visit. Follow-up time to Day 181 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Number of Participants With rSBA Titers ≥ 8 at Study Day 730 for Meningitis Serogroups A, C, W, Y and X
To assess the persistence of immune response elicited by a single dose of meningococcal vaccine, the number and proportion of participants with rSBA titers ≥ 8 at Day 730 is calculated for meningococcal serogroups A, C, W, Y and X. Endpoints are the number and proportion of participants with rSBA titers ≥ 8 for meningococcal serogroups A, C, W, Y and X, from samples collected at Visit 5 (Study Day 730). This is calculated for each study vaccination arm within each study age group (9 months or 15 months of age). Proportions are reported as percentages (number of infants per 100).
Time frame: Measured from time of meningococcal vaccination to blood sample collection at Day 730 visit. Follow-up time to Day 730 visit blood specimen collection was a mean (s.d.) of xx.x (x.x) days.
Other Pre-specified
Number of Participants With Serious Adverse Events (SAE) Through 2 Years of Follow-Up
To assess the safety and tolerability of a single dose of NmCV-5 or MenACWY-TT, when given concomitantly with routine vaccines, all Serious Adverse Events (SAE) occurring during 2 years of follow-up after meningococcal vaccination are reported. Endpoints are the number of participants with unsolicited adverse events that are reported as Serious Adverse Events (SAEs) according to ICH/GCP guidelines or the study protocol collected from the time of Step 2 randomization and vaccination and with date of event onset up to and including Study Day 730.
Time frame: Measured from time of meningococcal vaccination to Study Day 730 or early study termination, whichever is earlier. Follow-up time to Study Day 730 visit was a mean (s.d.) of xxx.x (x.x) days.