A Phase 2 interventional study of Non-adjuvanted study formulation NmCV-5 and Adjuvanted study formulation NmCV-5 in Meningitis, Meningococcal, sponsored by Serum Institute of India Pvt. Ltd.. Completed at 1 site in Mali. Open to participants aged 12 Months to 16 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Serum Institute of India Pvt. Ltd. · Phase 2, Interventional, and Prevention
Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.
Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5).
The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues.
This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).
Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose.
The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 375 is below the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Adjuvanted study formulation NmCV-5
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Non-adjuvanted study formulation NmCV-5
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Menactra
Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
Also known as: MenACYWX
Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
Also known as: Adj MenACYWX
Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
Also known as: MenACYW-D
Severe Solicited Adverse Event
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
Time frame: 7 days post each vaccination
Seroprotective rSBA Titres
Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)
Time frame: 112 days
Long Term Protective rSBA Titres
Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Time frame: 112 days
Rise in rSBA Titres
Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112. * For subjects with a pre-vaccination rSBA titer \< 8, a post-vaccination titer of ≥ 32; * For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer
Time frame: 112 days
Geometric Mean of rSBA Titres
rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Time frame: 112 Days
Solicited Reactions
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
Time frame: 7 days post each vaccination
Adverse Events
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
Time frame: 112 Days
Other Adverse Events
AEs leading to premature withdrawal during the entire study period;
Time frame: 168 Days
Serious Adverse Events
SAEs reported during the entire study period
Time frame: 168 Days
| Milestone | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Started | 150 | 150 | 76 |
| Received first vaccination | 149 | 150 | 76 |
| Received second vaccination | 144 | 145 | 73 |
| Completed | 144 | 145 | 71 |
| Not completed | 6 | 5 | 5 |
| Withdrew: Withdrawal by subject prior to initial vaccination | 1 | 0 | 0 |
| Withdrew: Death | 1 | 1 | 1 |
| Withdrew: Protocol violation | 4 | 3 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Subject discontinued due to travel | 0 | 1 | 0 |
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
| participants | Adjuvanted Study Formulation NmCV-5 | Non-adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose | 0 (0.00 to 2.45) | 0 (0.00 to 2.43) | 0 (0.00 to 4.74) |
| Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose | 0 (0.00 to 2.53) | 0 (0.00 to 2.51) | 0 (0.00 to 4.93) |
Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)
| Participants | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Serogroup A Day 0 | 16 | 19 | 10 |
| Serogroup A Day 28 | 144 | 144 | 71 |
| Serogroup A Day 84 | 144 | 144 | 71 |
| Serogroup A Day 112 | 144 | 144 | 72 |
| Serogroup C Day 0 | 3 | 0 | 0 |
| Serogroup C Day 28 | 143 | 143 | 56 |
| Serogroup C Day 84 | 141 | 139 | 51 |
| Serogroup C Day 112 | 144 | 144 | 72 |
| Serogroup W Day 0 | 9 | 6 | 2 |
| Serogroup W Day 28 | 142 | 141 | 65 |
| Serogroup W Day 84 | 140 | 142 | 59 |
| Serogroup W Day 112 | 144 | 144 | 72 |
| Serogroup X Day 0 | 15 | 12 | 6 |
| Serogroup X Day 28 | 144 | 143 | 15 |
| Serogroup X Day 84 | 144 | 143 | 14 |
| Serogroup X Day 112 | 143 | 144 | 25 |
| Serogroup Y Day 0 | 17 | 21 | 10 |
| Serogroup Y Day 28 | 141 | 143 | 64 |
| Serogroup Y Day 84 | 141 | 143 | 65 |
| Serogroup Y Day 112 | 144 | 144 | 71 |
Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
| Participants | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Serogroup A Day 0 | 16 | 18 | 10 |
| Serogroup A Day 28 | 144 | 144 | 71 |
| Serogroup A Day 84 | 144 | 143 | 71 |
| Serogroup A Day 112 | 144 | 144 | 72 |
| Serogroup C Day 0 | 2 | 0 | 0 |
| Serogroup C Day 28 | 142 | 140 | 39 |
| Serogroup C Day 84 | 133 | 131 | 26 |
| Serogroup C Day 112 | 144 | 144 | 68 |
| Serogroup W Day 0 | 8 | 5 | 2 |
| Serogroup W Day 28 | 142 | 141 | 65 |
| Serogroup W Day 84 | 137 | 139 | 57 |
| Serogroup W Day 112 | 144 | 144 | 69 |
| Serogroup X Day 0 | 15 | 12 | 6 |
| Serogroup X Day 28 | 144 | 143 | 15 |
| Serogroup X Day 84 | 144 | 143 | 14 |
| Serogroup X Day 112 | 143 | 144 | 22 |
| Serogroup Y Day 0 | 16 | 21 | 10 |
| Serogroup Y Day 28 | 140 | 143 | 64 |
| Serogroup Y Day 84 | 138 | 141 | 60 |
| Serogroup Y Day 112 | 144 | 144 | 66 |
Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112. * For subjects with a pre-vaccination rSBA titer \< 8, a post-vaccination titer of ≥ 32; * For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer
| Participants | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Serogroup A: Day 28 | 143 | 144 | 70 |
| Serogroup A: Day 112 | 143 | 144 | 71 |
| Serogroup C: Day 28 | 141 | 141 | 50 |
| Serogroup C: Day 112 | 142 | 144 | 72 |
| Serogroup W: Day 28 | 140 | 140 | 65 |
| Serogroup W: Day 112 | 142 | 143 | 71 |
| Serogroup X: Day 28 | 144 | 142 | 12 |
| Serogroup X: Day 112 | 143 | 143 | 19 |
| Serogroup Y: Day 28 | 140 | 142 | 63 |
| Serogroup Y: Day 112 | 144 | 142 | 71 |
rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
| Geometric Mean rSBA Titer | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Serogroup A Day 0 | 3.8 (2.81 to 5.18) | 4.3 (3.08 to 5.89) | 4.4 (2.74 to 6.95) |
| Serogroup A Day 28 | 7732.2 (6462.42 to 9251.52) | 7368.8 (6210.80 to 8742.81) | 3866.1 (2841.91 to 5259.43) |
| Serogroup A Day 84 | 4687.0 (3919.72 to 5604.44) | 4488.3 (3600.74 to 5594.57) | 2786.9 (2003.18 to 3877.24) |
| Serogroup A Day 112 | 6226.3 (5435.42 to 7132.33) | 6166.7 (5375.47 to 7047.35) | 4871.0 (3833.59 to 6189.12) |
| Serogroup C Day 0 | 2.2 (1.97 to 2.37) | 2.0 (NA to NA) | 2.0 (NA to NA) |
| Serogroup C Day 28 | 1143.9 (929.32 to 1407.98) | 1095.4 (877.66 to 1367.12) | 67.8 (39.69 to 115.84) |
| Serogroup C Day 84 | 436.8 (342.33 to 557.34) | 348.4 (272.51 to 445.33) | 29.6 (18.73 to 46.87) |
| Serogroup C Day 112 | 1366.9 (1173.58 to 1592.01) | 1393.4 (1200.54 to 1617.35) | 410.3 (324.93 to 518.11) |
| Serogroup W Day 0 | 2.8 (2.22 to 3.52) | 2.5 (2.09 to 2.91) | 2.2 (1.91 to 2.64) |
| Serogroup W Day 28 | 6533.4 (4868.00 to 8768.46) | 5363.2 (3927.83 to 7323.21) | 1127.5 (614.73 to 2067.93) |
| Serogroup W Day 84 | 2555.6 (1839.63 to 3550.22) | 2222.6 (1673.59 to 2951.80) | 483.3 (242.96 to 961.24) |
| Serogroup W Day 112 | 8035.8 (6255.62 to 10322.51) | 7056.4 (5622.17 to 8856.57) | 2482.8 (1567.27 to 3933.27) |
| Serogroup X Day 0 | 3.5 (2.70 to 4.61) | 3.2 (2.50 to 4.19) | 3.2 (2.21 to 4.66) |
| Serogroup X Day 28 | 7548.3 (6442.99 to 8843.32) | 8152.7 (6717.91 to 9893.84) | 6.9 (3.82 to 12.56) |
| Serogroup X Day 84 | 3511.3 (2934.73 to 4201.08) | 3113.2 (2552.53 to 3796.93) | 6.7 (3.73 to 11.91) |
| Serogroup X Day 112 | 5363.2 (4523.30 to 6359.15) | 6286.6 (5515.16 to 7165.86) | 11.6 (6.35 to 21.34) |
| Serogroup Y Day 0 | 3.6 (2.74 to 4.64) | 4.1 (3.08 to 5.55) | 3.9 (2.63 to 5.86) |
| Serogroup Y Day 28 | 2366.2 (1837.37 to 3047.14) | 3010.0 (2490.61 to 3637.74) | 676.9 (392.43 to 1167.54) |
| Serogroup Y Day 84 | 1171.7 (891.95 to 1539.31) | 1386.8 (1129.10 to 1703.21) | 426.4 (252.21 to 720.93) |
| Serogroup Y Day 112 | 3189.0 (2700.52 to 3765.84) | 3266.7 (2800.84 to 3810.01) | 1194.5 (809.00 to 1763.78) |
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
| Participants | Non-adjuvanted NmCV-5 (Days 0-6) | Adjuvanted NmCV-5 (Days 0-6) | Menactra (Days 0-6) | Non-adjuvanted NmCV-5 (Days 84-90) | Adjuvanted NmCV-5 (Days 84-90) | Menactra (Days 84-90) |
|---|---|---|---|---|---|---|
| Number of subjects with any Solicited AE | 9 | 8 | 5 | 1 | 2 | 2 |
| Any Solicited Local AE | 1 | 2 | 3 | 0 | 0 | 0 |
| Tenderness | 1 | 1 | 3 | 0 | 0 | 0 |
| Swelling/Induration | 0 | 1 | 0 | 0 | 0 | 0 |
| Any Solicited Systemic AE | 8 | 6 | 3 | 1 | 2 | 2 |
| Irritability | 1 | 0 | 1 | 0 | 0 | 0 |
| Drowsiness | 1 | 0 | 0 | 0 | 0 | 0 |
| Decrease eating | 4 | 2 | 2 | 0 | 0 | 0 |
| Vomiting | 3 | 4 | 0 | 1 | 1 | 1 |
| Fever | 4 | 2 | 3 | 0 | 1 | 2 |
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
| Participants | Non-adjuvanted NmCV-5 (Days 0-27) | Adjuvanted NmCV-5 (Days 0-27) | Menactra (Days 0-27) | Non-adjuvanted NmCV-5 (Days 84-111) | Adjuvanted NmCV-5 (Days 84-111) | Menactra (Days 84-111) |
|---|---|---|---|---|---|---|
| At least one Unsolicited AE | 37 | 39 | 23 | 23 | 17 | 16 |
| At least one related Unsolicited AE | 2 | 0 | 0 | 0 | 0 | 0 |
| At least one serious unsolicited AE | 0 | 0 | 0 | 0 | 0 | 0 |
| At least one serious related unsolicited AE | 0 | 0 | 0 | 0 | 0 | 0 |
| Unsolicited AEs leading to withdrawal from Study | 0 | 0 | 0 | 0 | 0 | 0 |
| Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study | 0 | 0 | 0 | 0 | 0 | 0 |
| unsolicited AEs leading to hospitalization | 0 | 0 | 0 | 0 | 0 | 0 |
| Unsolicited AEs leading to Death | 0 | 0 | 0 | 0 | 0 | 0 |
AEs leading to premature withdrawal during the entire study period;
| Number of events | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Other Adverse Events | 1 | 1 | 1 |
SAEs reported during the entire study period
| Number of events | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra |
|---|---|---|---|
| Serious Adverse Events | 1 | 1 | 1 |
Collected over Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-adjuvanted NmCV-5 Dose 1 | 1/149 (0.7%) | 1/149 (0.7%) | 41/149 (27.5%) |
| Adjuvanted NmCV-5 Dose 1 | 1/150 (0.7%) | 1/150 (0.7%) | 44/150 (29.3%) |
| Menactra Dose 1 | 0/76 (0%) | 0/76 (0%) | 25/76 (32.9%) |
| Non-adjuvanted NmCV-5 Dose 2 | 0/144 (0%) | 0/144 (0%) | 24/144 (16.7%) |
| Adjuvanted NmCV-5 Dose 2 | 0/145 (0%) | 0/145 (0%) | 17/145 (11.7%) |
| Menactra Dose 2 | 1/73 (1.4%) | 1/73 (1.4%) | 16/73 (21.9%) |
| Event | Non-adjuvanted NmCV-5 Dose 1 | Adjuvanted NmCV-5 Dose 1 | Menactra Dose 1 | Non-adjuvanted NmCV-5 Dose 2 | Adjuvanted NmCV-5 Dose 2 | Menactra Dose 2 |
|---|---|---|---|---|---|---|
| Burns second degreeInjury, poisoning and procedural complications | 0/149 | 0/150 | 0/76 | 0/144 | 0/145 | 1/73 |
| PneumoniaInfections and infestations | 1/149 | 0/150 | 0/76 | 0/144 | 0/145 | 0/73 |
| Escheria SepsisInfections and infestations | 0/149 | 1/150 | 0/76 | 0/144 | 0/145 | 0/73 |
| Event | Non-adjuvanted NmCV-5 Dose 1 | Adjuvanted NmCV-5 Dose 1 | Menactra Dose 1 | Non-adjuvanted NmCV-5 Dose 2 | Adjuvanted NmCV-5 Dose 2 | Menactra Dose 2 |
|---|---|---|---|---|---|---|
| BronchitisInfections and infestations | 9/149 | 5/150 | 7/76 | 7/144 | 4/145 | 2/73 |
| RhinitisInfections and infestations | 8/149 | 11/150 | 7/76 | 1/144 | 2/145 | 3/73 |
| PharyngitisInfections and infestations | 10/149 | 11/150 | 1/76 | 4/144 | 5/145 | 1/73 |
| NasopharyngitisInfections and infestations | 6/149 | 10/150 | 5/76 | 7/144 | 1/145 | 5/73 |
| GastroenteritisInfections and infestations | 5/149 | 2/150 | 1/76 | 3/144 | 3/145 | 3/73 |
| Injection Site TendernessGeneral disorders | 1/149 | 1/150 | 3/76 | 0/144 | 0/145 | 0/73 |
| FeverGeneral disorders | 4/149 | 2/150 | 3/76 | 0/144 | 1/145 | 2/73 |
| Decrease EatingGeneral disorders | 4/149 | 2/150 | 2/76 | 0/144 | 0/145 | 0/73 |
| DiarrhoeaGastrointestinal disorders | 4/149 | 2/150 | 1/76 | 0/144 | 0/145 | 1/73 |
| VomitingGeneral disorders | 3/149 | 4/150 | 0/76 | 1/144 | 1/145 | 1/73 |
| Age, Continuous(Months) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Mean | 12.1 ± 0.60 | 12.1 ± 0.53 | 12.1 ± 0.44 | 12.1 ± 0.54 |
| Sex: Female, Male(Participants) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Female | 73 | 68 | 36 | 177 |
| Male | 76 | 82 | 40 | 198 |
| Ethnicity (NIH/OMB)(Participants) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 149 | 150 | 76 | 375 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 149 | 150 | 76 | 375 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Length (cm)(centimeters) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Mean | 72.94 ± 2.533 | 73.03 ± 2.858 | 72.59 ± 2.460 | 72.91 ± 2.652 |
| Weight (kg)(kilograms) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Mean | 8.81 ± 1.002 | 8.89 ± 1.140 | 8.77 ± 1.007 | 8.83 ± 1.059 |
| Temperature (°C)(Celsius) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Mean | 36.25 ± 0.266 | 36.24 ± 0.299 | 36.24 ± 0.270 | 36.25 ± 0.279 |
| Heart Rate (beats/min)(Beats/minute) | Non-adjuvanted Study Formulation NmCV-5 | Adjuvanted Study Formulation NmCV-5 | Menactra | Total |
|---|---|---|---|---|
| Mean | 110.8 ± 5.80 | 111.3 ± 5.74 | 110.8 ± 6.09 | 111.0 ± 5.83 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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