A Phase 3 interventional study of NmCV-5 and MenACWY-TT in Meningitis, sponsored by Emory University. Completed at 1 site in Mali. Open to participants aged 9 Months to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Emory University · Phase 3, Interventional, and Prevention
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.
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.
268 studies on the registry are indexed under Meningitis; 28 are open to participants now.
This study's enrollment of 1,325 is above the median of 260 across 185 interventional studies indexed under Meningitis.
Browse Meningitis studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 9 months of age, while receiving the current Mali EPI schedule of vaccines.
Biological: NmCV-5
Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 9 months of age, while receiving the current Mali EPI schedule of vaccines.
Biological: MenACWY-TT
Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 15 months of age, while receiving the current Mali EPI schedule of vaccines.
Biological: NmCV-5
Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 15 months of age, while receiving the current Mali EPI schedule of vaccines.
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).
MenACWY-TT (the comparator meningococcal vaccine) is a WHO-PQ quadrivalent meningococcal (A, C, Y, W) polysaccharide-conjugate vaccine manufactured by Pfizer.
Also known as: Nimenrix
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Participants were recruited in Mali, enrollment began March 24, 2022, and all follow up at Day 29 was complete by March 10, 2023.
| Milestone | Vaccination at 9 Months of Age With NmCV-5 | Vaccination at 9 Months of Age With MenACWY-TT | Not Vaccinated But Randomized to Vaccination at 15 Months of Age | Vaccination at 15 Months of Age With NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|---|
| Started | 401 | 201 | 123 | 400 | 200 |
| Completed | 401 | 201 | 123 | 400 | 200 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Vaccination at 9 Months of Age With NmCV-5 | Vaccination at 9 Months of Age With MenACWY-TT | Not Vaccinated But Randomized to Vaccination at 15 Months of Age | Vaccination at 15 Months of Age With NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|---|
| Started | 401 | 201 | 123 | 400 | 200 |
| Completed | 401 | 201 | 0 | 400 | 200 |
| Not completed | 0 | 0 | 123 | 0 | 0 |
| Withdrew: Lost to follow-up, ineligibility, or group 2 target met | 0 | 0 | 123 | 0 | 0 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants with seroprotective response against meningococcal serogroup A — Yes | 373 | 191 | 366 | 180 |
| Participants with seroprotective response against meningococcal serogroup A — No | 0 | 0 | 1 | 2 |
| Participants with seroprotective response against meningococcal serogroup C — Yes | 369 | 190 | 358 | 179 |
| Participants with seroprotective response against meningococcal serogroup C — No | 4 | 1 | 9 | 3 |
| Participants with seroprotective response against meningococcal serogroup W — Yes | 352 | 186 | 362 | 179 |
| Participants with seroprotective response against meningococcal serogroup W — No | 21 | 5 | 5 | 3 |
| Participants with seroprotective response against meningococcal serogroup Y — Yes | 360 | 190 | 364 | 178 |
| Participants with seroprotective response against meningococcal serogroup Y — No | 13 | 1 | 3 | 4 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) — Yes | 371 | 186 | — | — |
| Participants with seroprotective response against serogroup X (NmCV-5) and serogroup W (MenACWY-TT) — No | 1 | 5 | — | — |
| Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) — Yes | — | — | 366 | 178 |
| Participants with seroprotective response against serogroup X (NmCV-5) and serogroup Y (MenACWY-TT) — No | — | — | 1 | 4 |
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.
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants experiencing SAE — Yes | 1 | 0 | 2 | 1 |
| Participants experiencing SAE — No | 399 | 200 | 398 | 199 |
| Gastroenteritis — Yes | 0 | 0 | 1 | 0 |
| Gastroenteritis — No | 400 | 200 | 399 | 200 |
| Thermal burn — Yes | 0 | 0 | 1 | 1 |
| Thermal burn — No | 400 | 200 | 399 | 199 |
| Malnutrition — Yes | 1 | 0 | 0 | 0 |
| Malnutrition — No | 399 | 200 | 400 | 200 |
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.
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants experiencing a solicited AE — Yes | 250 | 137 | 115 | 45 |
| Participants experiencing a solicited AE — No | 150 | 63 | 285 | 155 |
| Participants experiencing a solicited AE — Not Evaluated | 0 | 0 | 0 | 0 |
| Participants experiencing a local solicited AE — Yes | 238 | 129 | 106 | 44 |
| Participants experiencing a local solicited AE — No | 162 | 71 | 294 | 156 |
| Participants experiencing a local solicited AE — Not Evaluated | 0 | 0 | 0 | 0 |
| Erythema/redness — Yes | 1 | 3 | 0 | 0 |
| Erythema/redness — No | 399 | 197 | 400 | 200 |
| Erythema/redness — Not Evaluated | 0 | 0 | 0 | 0 |
| Induration/swelling — Yes | 48 | 31 | 2 | 0 |
| Induration/swelling — No | 352 | 169 | 398 | 200 |
| Induration/swelling — Not Evaluated | 0 | 0 | 0 | 0 |
| Pain and/or tenderness — Yes | 224 | 120 | 106 | 44 |
| Pain and/or tenderness — No | 176 | 80 | 294 | 156 |
| Pain and/or tenderness — Not Evaluated | 0 | 0 | 0 | 0 |
| Participants experiencing a systemic solicited AE — Yes | 60 | 32 | 16 | 3 |
| Participants experiencing a systemic solicited AE — No | 340 | 168 | 384 | 197 |
| Participants experiencing a systemic solicited AE — Not Evaluated | 0 | 0 | 0 | 0 |
| Irritability — Yes | 17 | 5 | 3 | 1 |
| Irritability — No | 383 | 195 | 397 | 199 |
| Irritability — Not Evaluated | 0 | 0 | 0 | 0 |
| Drowsiness/lethargy — Yes | 4 | 2 | 3 | 1 |
| Drowsiness/lethargy — No | 396 | 198 | 397 | 199 |
| Drowsiness/lethargy — Not Evaluated | 0 | 0 | 0 | 0 |
| Decrease eating/anorexia — Yes | 2 | 0 | 4 | 1 |
| Decrease eating/anorexia — No | 398 | 200 | 396 | 199 |
| Decrease eating/anorexia — Not Evaluated | 0 | 0 | 0 | 0 |
| Vomiting — Yes | 4 | 3 | 5 | 1 |
| Vomiting — No | 396 | 197 | 395 | 199 |
| Vomiting — Not Evaluated | 0 | 0 | 0 | 0 |
| Fever (axillary) — Yes | 6 | 5 | 3 | 2 |
| Fever (axillary) — No | 394 | 195 | 397 | 198 |
| Fever (axillary) — Not Evaluated | 0 | 0 | 0 | 0 |
| Feverish — Yes | 41 | 20 | 7 | 2 |
| Feverish — No | 147 | 73 | 393 | 198 |
| Feverish — Not Evaluated | 212 | 107 | 0 | 0 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants experiencing an unsolicited AE — Yes | 64 | 37 | 16 | 8 |
| Participants experiencing an unsolicited AE — No | 336 | 163 | 384 | 192 |
| Allergic cough — Yes | 1 | 0 | 0 | 0 |
| Allergic cough — No | 399 | 200 | 400 | 200 |
| Bronchitis — Yes | 10 | 13 | 4 | 3 |
| Bronchitis — No | 390 | 187 | 396 | 197 |
| Conjunctivitis — Yes | 0 | 0 | 1 | 1 |
| Conjunctivitis — No | 400 | 200 | 399 | 199 |
| Diarrhoea — Yes | 19 | 7 | 1 | 1 |
| Diarrhoea — No | 381 | 193 | 399 | 199 |
| Gastroenteritis — Yes | 5 | 3 | 4 | 0 |
| Gastroenteritis — No | 395 | 197 | 396 | 200 |
| Impetigo — Yes | 4 | 4 | 0 | 0 |
| Impetigo — No | 396 | 196 | 400 | 200 |
| Malaria — Yes | 1 | 0 | 0 | 0 |
| Malaria — No | 399 | 200 | 400 | 200 |
| Nasopharyngitis — Yes | 2 | 2 | 0 | 0 |
| Nasopharyngitis — No | 398 | 198 | 400 | 200 |
| Otitis media acute — Yes | 1 | 1 | 0 | 0 |
| Otitis media acute — No | 399 | 199 | 400 | 200 |
| Otorrhoea — Yes | 2 | 0 | 0 | 0 |
| Otorrhoea — No | 398 | 200 | 400 | 200 |
| Pharyngitis — Yes | 9 | 5 | 5 | 2 |
| Pharyngitis — No | 391 | 195 | 395 | 198 |
| Pyoderma — Yes | 9 | 3 | 0 | 0 |
| Pyoderma — No | 391 | 197 | 400 | 200 |
| Rhinitis — Yes | 5 | 2 | 2 | 1 |
| Rhinitis — No | 395 | 198 | 398 | 199 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Yes | 371 | 33 | 366 | 57 |
| No | 1 | 158 | 1 | 125 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Yes | 364 | 187 | 364 | 176 |
| No | 0 | 0 | 0 | 0 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Yes | 294 | 159 | 364 | 176 |
| No | 70 | 28 | 0 | 0 |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Yes | 355 | 186 | — | — |
| No | 9 | 1 | — | — |
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).
| rSBA titer | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Serogroup A | 8131.3 (7187.9 to 9198.6) | 7814.5 (6706.2 to 9105.9) | 13436.7 (11822.1 to 15271.9) | 10942.0 (8774.4 to 13644.9) |
| Serogroup C | 738.3 (636.1 to 857.0) | 1565.7 (1296.1 to 1891.4) | 807.1 (689.2 to 945.2) | 2103.3 (1705.4 to 2594.2) |
| Serogroup W | 2612.5 (2034.2 to 3355.1) | 2933.3 (2281.1 to 3772.0) | 7383.7 (6159.8 to 8850.9) | 4733.8 (3634.4 to 6165.8) |
| Serogroup Y | 2086.4 (1731.6 to 2514.0) | 2798.2 (2350.1 to 3331.7) | 3629.6 (3208.7 to 4105.9) | 3598.5 (2848.6 to 4545.8) |
| Serogroup X | 7352.8 (6640.7 to 8141.4) | 4.9 (3.6 to 6.6) | 9262.0 (8244.3 to 10405.3) | 12.1 (8.1 to 18.1) |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Participants with Serogroup A Seroresponse — Yes | 98 | 47 | 116 | 57 |
| Participants with Serogroup A Seroresponse — No | 0 | 1 | 2 | 4 |
| Participants with Serogroup C Seroresponse — Yes | 96 | 47 | 112 | 58 |
| Participants with Serogroup C Seroresponse — No | 2 | 1 | 6 | 3 |
| Participants with Serogroup W Seroresponse — Yes | 92 | 48 | 117 | 59 |
| Participants with Serogroup W Seroresponse — No | 6 | 0 | 1 | 2 |
| Participants with Serogroup Y Seroresponse — Yes | 94 | 48 | 117 | 57 |
| Participants with Serogroup Y Seroresponse — No | 4 | 0 | 1 | 4 |
| Participants with Serogroup X Seroresponse — Yes | 97 | 7 | 115 | 9 |
| Participants with Serogroup X Seroresponse — No | 0 | 41 | 3 | 52 |
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.
| rSBA titer | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Serogroup A, Day 1 | 2.6 (2.1 to 3.2) | 3.3 (2.0 to 5.5) | 10.6 (6.8 to 16.5) | 8.2 (4.5 to 14.7) |
| Serogroup A, Day 29 | 7111.4 (5538.4 to 9131.2) | 8554.7 (6613.9 to 11064.9) | 13817.8 (11112.3 to 17182.0) | 7917.4 (4920.2 to 12740.4) |
| Serogroup C, Day 1 | 2.2 (2.0 to 2.4) | 2.4 (1.9 to 3.1) | 2.2 (2.0 to 2.5) | 2.3 (1.9 to 2.7) |
| Serogroup C, Day 29 | 633.0 (474.3 to 844.9) | 1602.2 (1039.7 to 2469.0) | 647.6 (488.0 to 859.4) | 1934.9 (1202.6 to 3113.1) |
| Serogroup W, Day 1 | 2.2 (1.9 to 2.5) | 2.5 (1.8 to 3.3) | 2.4 (2.1 to 2.8) | 2.3 (1.9 to 2.8) |
| Serogroup W, Day 29 | 2326.1 (1504.8 to 3595.5) | 4801.2 (3587.7 to 6425.0) | 7770.2 (5686.2 to 10617.9) | 3226.5 (1934.9 to 5380.1) |
| Serogroup Y, Day 1 | 2.4 (2.0 to 2.8) | 2.4 (1.9 to 3.0) | 5.7 (4.0 to 8.2) | 5.4 (3.1 to 9.2) |
| Serogroup Y, Day 29 | 1908.2 (1326.1 to 2745.6) | 3494.4 (2505.3 to 4874.1) | 3454.4 (2783.3 to 4287.4) | 3083.1 (1848.0 to 5143.6) |
| Serogroup X, Day 1 | 2.5 (2.1 to 3.1) | 2.2 (1.9 to 2.6) | 6.2 (4.2 to 9.1) | 8.3 (4.5 to 15.1) |
| Serogroup X, Day 29 | 6706.5 (5625.7 to 7995.0) | 4.4 (2.5 to 7.7) | 8687.6 (7142.1 to 10567.6) | 16.2 (7.6 to 34.4) |
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).
| Participants | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|
| Serogroup A, Participants with rSBA titer ≥ 128 — Yes | 372 | 191 | 366 | 180 |
| Serogroup A, Participants with rSBA titer ≥ 128 — No | 1 | 0 | 1 | 2 |
| Serogroup C, Participants with rSBA titer ≥ 128 — Yes | 354 | 187 | 351 | 179 |
| Serogroup C, Participants with rSBA titer ≥ 128 — No | 19 | 4 | 16 | 3 |
| Serogroup W, Participants with rSBA titer ≥ 128 — Yes | 348 | 185 | 362 | 177 |
| Serogroup W, Participants with rSBA titer ≥ 128 — No | 25 | 6 | 5 | 5 |
| Serogroup Y, Participants with rSBA titer ≥ 128 — Yes | 356 | 190 | 364 | 178 |
| Serogroup Y, Participants with rSBA titer ≥ 128 — No | 17 | 1 | 3 | 4 |
| Serogroup X, Participants with rSBA titer ≥ 128 — Yes | 371 | 29 | 366 | 51 |
| Serogroup X, Participants with rSBA titer ≥ 128 — No | 1 | 162 | 1 | 131 |
Collected over Serious adverse events (SAEs) are recorded from the time of enrollment to Study Day 181. SAE follow-up time was approximately 6 months for participants receiving meningococcal vaccination at 9 months of age and for participants in Group 2 but not receiving meningococcal vaccination. SAE follow-up time was approximately 12 months for participants receiving vaccination at 15 months of age. Other non-serious AEs are reported from study vaccination through 28 days after vaccination(mITT population).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccination at 9 Months of Age With NmCV-5 | 0/401 (0%) | 1/401 (0.2%) | 64/400 (16%) |
| Vaccination at 9 Months of Age With MenACWY-TT | 0/201 (0%) | 0/201 (0%) | 37/200 (18.5%) |
| Not Vaccinated But Randomized to Vaccination at 15 Months of Age | 1/123 (0.8%) | 1/123 (0.8%) | — |
| Vaccination at 15 Months of Age With NmCV-5 | 0/400 (0%) | 2/400 (0.5%) | 16/400 (4%) |
| Vaccination at 15 Months of Age With MenACWY-TT | 0/200 (0%) | 1/200 (0.5%) | 8/200 (4%) |
| Event | Vaccination at 9 Months of Age With NmCV-5 | Vaccination at 9 Months of Age With MenACWY-TT | Not Vaccinated But Randomized to Vaccination at 15 Months of Age | Vaccination at 15 Months of Age With NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|---|
| MalariaInfections and infestations | 0/401 | 0/201 | 1/123 | 0/400 | 0/200 |
| Thermal burnInjury, poisoning and procedural complications | 0/401 | 0/201 | 0/123 | 1/400 | 1/200 |
| GastroenteritisInfections and infestations | 0/401 | 0/201 | 0/123 | 1/400 | 0/200 |
| MalnutritionMetabolism and nutrition disorders | 1/401 | 0/201 | 0/123 | 0/400 | 0/200 |
| Event | Vaccination at 9 Months of Age With NmCV-5 | Vaccination at 9 Months of Age With MenACWY-TT | Not Vaccinated But Randomized to Vaccination at 15 Months of Age | Vaccination at 15 Months of Age With NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT |
|---|---|---|---|---|---|
| BronchitisInfections and infestations | 10/400 | 13/200 | — | 4/400 | 3/200 |
| DiarrhoeaGastrointestinal disorders | 19/400 | 7/200 | — | 1/400 | 1/200 |
| PharyngitisInfections and infestations | 9/400 | 5/200 | — | 5/400 | 2/200 |
| PyodermaInfections and infestations | 9/400 | 3/200 | — | 0/400 | 0/200 |
| ImpetigoInfections and infestations | 4/400 | 4/200 | — | 0/400 | 0/200 |
| GastroenteritisInfections and infestations | 5/400 | 3/200 | — | 4/400 | 0/200 |
| RhinitisInfections and infestations | 5/400 | 2/200 | — | 2/400 | 1/200 |
| NasopharyngitisInfections and infestations | 2/400 | 2/200 | — | 0/400 | 0/200 |
| ConjunctivitisInfections and infestations | 0/400 | 0/200 | — | 1/400 | 1/200 |
| Otitis media acuteInfections and infestations | 1/400 | 1/200 | — | 0/400 | 0/200 |
Two participants refused the meningococcal vaccination (1 participant in each vaccine study arm in Group 1, meningococcal vaccination at 9 months of age) and were excluded from the mITT analysis set.
| Age, Continuous(months) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mean | 9.3 ± 0.5 | 9.3 ± 0.5 | 9.3 ± 0.5 | 9.2 ± 0.5 | 9.3 ± 0.5 |
| Sex: Female, Male(Participants) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Female | 203 | 101 | 201 | 108 | 613 |
| Male | 197 | 99 | 199 | 92 | 587 |
| Race/Ethnicity, Customized(Participants) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| African | 400 | 200 | 400 | 200 | 1200 |
| Region of Enrollment(participants) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mali | 400 | 200 | 400 | 200 | 1200 |
| Participant Height/Length(cm) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mean | 70.1 ± 2.4 | 70.2 ± 2.9 | 70.0 ± 2.6 | 69.9 ± 2.5 | 70.0 ± 2.6 |
| Participant weight(kg) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mean | 8.1 ± 1.0 | 8.0 ± 1.1 | 8.1 ± 1.0 | 8.0 ± 0.9 | 8.0 ± 1.0 |
| Participant Length-for-weight z-score(z-score) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mean | -0.4 ± 1.1 | -0.5 ± 1.1 | -0.4 ± 1.1 | -0.5 ± 1.0 | -0.4 ± 1.1 |
| Participant Body Temperature(Celcius) | 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 NmCV-5 | Vaccination at 15 Months of Age With MenACWY-TT | Total |
|---|---|---|---|---|---|
| Mean | 36.0 ± 0.4 | 36.0 ± 0.4 | 36.1 ± 0.4 | 36.1 ± 0.4 | 36.0 ± 0.4 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2022 to primary completion in Mar 2023, 11 months.
Results were first posted in May 2024, 1 year 1 month after primary completion.
Of 19 phase 3 interventional studies under Meningitis, half reached primary completion within 15 months of starting (the median); a quarter within 7 and three quarters within 28. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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