Meningitis, MeningococcalPhase 2NCT03295318
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
A Phase 2 study testing Non-adjuvanted study formulation NmCV-5, Adjuvanted study formulation NmCV-5 and Menactra in people with Meningitis, Meningococcal, run by Serum Institute of India Pvt. Ltd. at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Non-adjuvanted study formulation NmCV-5, Adjuvanted study formulation NmCV-5 and Menactra
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteMali
- Study dates
- 15 Nov 2017to 31 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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).
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mali1 site
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, BP251
About this study
Official title: A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age
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).
Read more
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
- Meningitis, Meningococcal
- Being tested
- Non-adjuvanted study formulation NmCV-5, Adjuvanted study formulation NmCV-5, Menactra
- Keywords
- Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adjuvanted study formulation NmCV-5Biological
Also called MenACYWX
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.
Adjuvanted study formulation NmCV-5Biological
Also called Adj 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
MenactraBiological
Also called MenACYW-D
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvanted study formulation NmCV-5 | Experimental | 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. Receives: Biological: Adjuvanted study formulation NmCV-5 |
| Non-adjuvanted study formulation NmCV-5 | Experimental | 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. Receives: Biological: Non-adjuvanted study formulation NmCV-5 |
| Menactra | Active comparator | 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. Receives: Biological: Menactra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days post each vaccination
Secondary outcomes (8)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 112 Days
Solicited Reactions
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
Measured: 7 days post each vaccination
Adverse Events
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
Measured: 112 Days
Other Adverse Events
AEs leading to premature withdrawal during the entire study period;
Measured: 168 Days
Serious Adverse Events
SAEs reported during the entire study period
Measured: 168 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start15 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295318
- Sponsor's protocol ID
- ACYWX-002
- Other IDs
- CVIA-058
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2017
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age
- ClinicalTrials.gov ID
- NCT03295318
- Acronym / sponsor ID
- ACYWX-002
- Conditions
- Meningitis, Meningococcal
- Keywords
- Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjuvanted study formulation NmCV-5 | Experimental | Biological: Adjuvanted study formulation NmCV-5Subjects 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. |
| Non-adjuvanted study formulation NmCV-5 | Experimental | Biological: Non-adjuvanted study formulation NmCV-5Subjects 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. |
| Menactra | Active comparator | Biological: MenactraSubjects 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. |
Who may qualify
- Ages
- 12 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-adjuvanted study formulation NmCV-5Also: MenACYWXNon-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. | Biological | Non-adjuvanted study formulation NmCV-5 |
| Adjuvanted study formulation NmCV-5Also: Adj MenACYWXAdjuvanted 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 | Biological | Adjuvanted study formulation NmCV-5 |
| MenactraAlso: MenACYW-DMenactra 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. | Biological | Menactra |
Primary outcome
Severe Solicited Adverse Event
Time frame: 7 days post each vaccination
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)
8 secondary outcomes
Seroprotective rSBA Titres
Time frame: 112 days
Long Term Protective rSBA Titres
Time frame: 112 days
Rise in rSBA Titres
Time frame: 112 days
Geometric Mean of rSBA Titres
Time frame: 112 Days
Solicited Reactions
Time frame: 7 days post each vaccination
Adverse Events
Time frame: 112 Days
Other Adverse Events
Time frame: 168 Days
Serious Adverse Events
Time frame: 168 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34077644Tapia 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.
- Individual participant dataSharing planned: Undecided
Related trials for Meningitis, Meningococcal
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non-adjuvanted study formulation NmCV-5, Adjuvanted study formulation NmCV-5 and Menactra in people with Meningitis, Meningococcal, run by Serum Institute of India Pvt. Ltd. at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Solicited Adverse Event (time frame: 7 days post each vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.