ClinicalTrials.gg
CompletedNCT03964012Updated Jul 27, 2021

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

A Phase 3 interventional study of NmCV-5 and Menactra in Meningococcal Meningitis, sponsored by Serum Institute of India Pvt. Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 2 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Serum Institute of India Pvt. Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,800
Allocation
Randomized
Ages
2 Years to 29 Years
Sex
All
01

Study summary

This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra.

A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years \& 2-10 years (400 NmCV-5 recipients \& 200 Menactra recipients in each age strata).

Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).

02

Conditions studied

  • Meningococcal Meningitis

Keywords

  • Neisseria meningitidis
  • conjugate meningococcal vaccine
  • Meningococcal serogroup X
03

In context

Meningitis, Meningococcal

125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.

This study's enrollment of 1,800 is above the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.

Browse Meningitis, Meningococcal studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
2 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
  2. Written obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia).
  3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
  4. Female subjects of must have practiced adequate for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
  5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration

Exclusion criteria

Exclusion Criteria:

  1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
  2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
  3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
  4. Current or previous, confirmed disease caused by Neisseria meningitidis.
  5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
  6. Known to any component of the study IPs (i.e., NmCV-5 or Menactra®).
  7. History of significant hypersensitivity reactions to any previous vaccine.
  8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit.
  9. Administration of any drug within 30 days prior to study IP administration or planned administration during the study period.
  10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.
  11. Administration of immunoglobulin or any blood product within 90 days prior to study IP administration or planned administration during the study period.
  12. Administration of or other immune modifying agents within 90 days prior to study IP administration
  13. Administration of systemic antibiotic treatment within 3 days prior to study IP administration.
  14. Any history of or evidence for chronic (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
  15. Any history of , chronic or chronic infections.
  16. History of meningitis, seizures, Guillain-Barré syndrome (GBS), or other neurological disorders.
  17. History of or family history of congenital or hereditary immunodeficiency.
  18. Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
  19. Pregnancy
  20. Previous inclusion in the study of five immediate family members (i.e., biological father, mother, subject, and brothers and sisters may be included up to a maximum of five members from the same immediate family).
Terms in these criteria, in plain language(10)

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,800 participants (actual)

Study arms

  • Experimental
    NmCV-5

    Subjects in this arm will receive polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W \& X. A single dose of 0.5 mL will be administered intramuscularly.

    Biological: NmCV-5

  • Active comparator
    Menactra

    Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, \& W viz. Menactra. A single dose of 0.5 mL will be administered intramuscularly.

    Biological: Menactra

Interventions

  • BiologicalNmCV-5

    Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.

    Also known as: MenACYWX

  • BiologicalMenactra

    Menactra is available as ready to use solution containing polysaccharide 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

06

What researchers measure

Primary outcomes

  1. Seroresponse

    Percentage of subjects with seroresponse, measured by rabbit complement serum bactericidal activity (rSBA) against serogroups A, C, Y, W and X. \[Seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the subject's pre-immunization (Day 1) rSBA titer was \< 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the subject's pre-immunization (Day 1) rSBA titer was ≥ 8\].

    Time frame: 28 Days post vaccination

  2. Geometric mean titres

    Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29

    Time frame: 28 Days post vaccination

Secondary outcomes

  1. Solicited adverse events

    Solicited AEs for 7 days following vaccination

    Time frame: 7 days post vaccination

  2. Unsolicited adverse events

    Unsolicited AEs for 28 days following vaccination

    Time frame: 28 days post vaccination

  3. Serious adverse events (SAEs)

    SAEs for 6 months following vaccination

    Time frame: 6 months post vaccination

  4. Seroprotective rSBA titres

    Percentage of subjects with rSBA titer of ≥ 8 against serogroups A, C, Y, W, and X at Day 1 and Day 29

    Time frame: 28 days post vaccination

  5. Long term protective rSBA titres

    Percentage of subjects with rSBA titer of ≥ 128 against serogroups A, C, Y, W, and X at Day 1 and Day 29

    Time frame: 28 days post vaccination

07

Study locations

2 sites
  • Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
    Fajara, Gambia
  • Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
    Bamako, BP251, Mali
08

References and documents

Publications

  • Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14. PubMed 30120069 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03964012
Collaborators
PATH
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Aug 20, 2019
Primary completion
Feb 23, 2020
Completion
Mar 4, 2021
Last update
Jul 27, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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