CompletedNCT03295318Updated May 25, 2025Results posted

Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

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

Phase: Phase 2
Study type: Interventional
Enrollment: 375
Allocation: Randomized
Ages: 12 Months to 16 Months
Sex: All

Study summary

Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.

Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5).

The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues.

This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).

Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose.

The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).

Conditions studied

Meningitis, Meningococcal

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Keywords

Neisseria meningitidis
conjugate meningococcal vaccine
meningococcal serogroup X

Who can participate

Ages eligible: 12 Months to 16 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age);
For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;
Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits);
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)

Exclusion criteria

Exclusion Criteria:

History of any meningococcal vaccine administration.
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment.
History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination.
Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
Severe acute malnutrition.
A family history of congenital or hereditary immunodeficiency.
History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection.
Major congenital defects.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed).
Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination.
Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
Malaria infection as confirmed by a Rapid Diagnostic Test.
Individuals who are close family members of individuals conducting this study.
Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment.
Have received systemic antibiotic treatment within 3 days prior to enrolment.
Non-residence in the study area or intent to move out within six months.
Any condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 375 participants (actual)

Study arms

Experimental
Adjuvanted study formulation NmCV-5
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Adjuvanted study formulation NmCV-5
Experimental
Non-adjuvanted study formulation NmCV-5
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Non-adjuvanted study formulation NmCV-5
Active comparator
Menactra
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
Biological: Menactra

Interventions

BiologicalNon-adjuvanted study formulation NmCV-5
Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
Also known as: MenACYWX
BiologicalAdjuvanted study formulation NmCV-5
Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
Also known as: Adj MenACYWX
BiologicalMenactra
Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
Also known as: MenACYW-D

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Sep 5, 2021

Participant flow

Participant flow — Overall Study
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

Outcome measures

PrimarySevere 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
Reported as:: Number · participants

Severe Solicited Adverse Event
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)

SecondarySeroprotective 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
Reported as:: Count of participants · Participants

Seroprotective rSBA Titres
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

SecondaryLong 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
Reported as:: Count of participants · Participants

Long Term Protective rSBA Titres
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

SecondaryRise 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
Reported as:: Count of participants · Participants

Rise in rSBA Titres
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

SecondaryGeometric 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
Reported as:: Geometric mean · Geometric Mean rSBA Titer

Geometric Mean of rSBA Titres
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)

SecondarySolicited 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
Reported as:: Count of participants · Participants

Solicited Reactions
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

SecondaryAdverse Events

Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);

Time frame:: 112 Days
Reported as:: Count of participants · Participants

Adverse Events
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

SecondaryOther Adverse Events

AEs leading to premature withdrawal during the entire study period;

Time frame:: 168 Days
Reported as:: Number · Number of events

Other Adverse Events
Number of events	Non-adjuvanted Study Formulation NmCV-5	Adjuvanted Study Formulation NmCV-5	Menactra
Other Adverse Events	1	1	1

SecondarySerious Adverse Events

SAEs reported during the entire study period

Time frame:: 168 Days
Reported as:: Number · Number of events

Serious Adverse Events
Number of events	Non-adjuvanted Study Formulation NmCV-5	Adjuvanted Study Formulation NmCV-5	Menactra
Serious Adverse Events	1	1	1

Adverse events

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.

Adverse event summary by group
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%)

Most frequent serious events

Most frequent serious events
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

Most frequent other events

Showing 10 of 22

Most frequent other events
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

Baseline characteristics

Age, Continuous
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
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)
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)
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)
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)
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)
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)
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.

Study locations

1 site

Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, BP251, Mali

References and documents

Publications

Tapia MD, Sow SO, Naficy A, Diallo F, Haidara FC, Chaudhari A, Martellet L, Traore A, Townsend-Payne K, Borrow R, Hosken N, Smolenov I, Pisal SS, LaForce FM, Dhere RM, Kapse D, Tang Y, Alderson MR, Kulkarni PS. Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. N Engl J Med. 2021 Jun 3;384(22):2115-2123. doi: 10.1056/NEJMoa2013615. PubMed 34077644 ↗

Study documents

Study protocol · Aug 11, 2017
Statistical analysis plan · Apr 29, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03295318
Lead sponsor: Serum Institute of India Pvt. Ltd.
Collaborators: PATH
Responsible party: Sponsor
First posted: Sep 27, 2017
Start date: Nov 15, 2017
Primary completion: Aug 31, 2018
Completion: Aug 31, 2018
Results posted: Sep 5, 2021
Last update: May 25, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Meningitis, Meningococcal→

Other studies from this sponsor

Serum Institute of India Pvt. Ltd.

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