Meningococcal MeningitisPhase 3NCT03964012
Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
A Phase 3 study testing NmCV-5 and Menactra in people with Meningococcal Meningitis, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- 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
- 1,800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Aug 2019to 4 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
- Written informed consent 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).
- Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
- Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
- Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration
Who cannot join
- 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).
- 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).
- Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
- Current or previous, confirmed disease caused by Neisseria meningitidis.
- Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
- Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®).
Show all 20Show fewer
- History of significant hypersensitivity reactions to any previous vaccine.
- 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.
- Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period.
- Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.
- Administration of immunoglobulin or any blood product within 90 days prior to study IP administration or planned administration during the study period.
- Administration of immunosuppressants or other immune modifying agents within 90 days prior to study IP administration
- Administration of systemic antibiotic treatment within 3 days prior to study IP administration.
- Any history of or evidence for chronic clinically significant (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).
- Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
- History of meningitis, seizures, Guillain-Barré syndrome (GBS), or other neurological disorders.
- History of or family history of congenital or hereditary immunodeficiency.
- 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.
- Pregnancy
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mali1 site
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, BP251
The Gambia1 site
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
Fajara
About this study
Official title: Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age
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).
- Conditions
- Meningococcal Meningitis
- Being tested
- 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.
NmCV-5Biological
Also called MenACYWX
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.
MenactraBiological
Also called MenACYW-D
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
| Study group | Role | What they receive |
|---|---|---|
| NmCV-5 | Experimental | 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. Receives: Biological: NmCV-5 |
| Menactra | Active comparator | 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. Receives: Biological: Menactra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 28 Days post vaccination
Geometric mean titres
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29
Measured: 28 Days post vaccination
Secondary outcomes (5)
Solicited adverse events
Solicited AEs for 7 days following vaccination
Measured: 7 days post vaccination
Unsolicited adverse events
Unsolicited AEs for 28 days following vaccination
Measured: 28 days post vaccination
Serious adverse events (SAEs)
SAEs for 6 months following vaccination
Measured: 6 months post vaccination
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
Measured: 28 days post vaccination
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
Measured: 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start20 Aug 2019
- Primary completion23 Feb 2020
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Meningococcal MeningitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 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
- NCT03964012
- Sponsor's protocol ID
- ACYWX-03
- Other IDs
- CVIA 071
- Status last verified
- May 2020
- First submitted
- 23 May 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 30120069Castilla J, Cenoz MG, Barricarte A. Meningococcal Group B Vaccine (4CMenB) in Children. Reply. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
PubMed 37256992Lopez-Lacort M, Munoz-Quiles C, Orrico-Sanchez A. Meningococcal Group B Vaccine (4CMenB) in Children. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
PubMed 37256991Haidara FC, Umesi A, Sow SO, Ochoge M, Diallo F, Imam A, Traore Y, Affleck L, Doumbia MF, Daffeh B, Kodio M, Wariri O, Traore A, Jallow E, Kampmann B, Kapse D, Kulkarni PS, Mallya A, Goel S, Sharma P, Sarma AD, Avalaskar N, LaForce FM, Alderson MR, Naficy A, Lamola S, Tang Y, Martellet L, Hosken N, Simeonidis E, Welsch JA, Tapia MD, Clarke E. Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. N Engl J Med. 2023 May 25;388(21):1942-1955. doi: 10.1056/NEJMoa2214924.
PubMed 37224196
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age
- ClinicalTrials.gov ID
- NCT03964012
- Acronym / sponsor ID
- ACYWX-03
- Conditions
- Meningococcal Meningitis
- Keywords
- Neisseria meningitidis, conjugate meningococcal vaccine, Meningococcal serogroup X
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 23 Feb 2020 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NmCV-5 | Experimental | Biological: NmCV-5Subjects 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. |
| Menactra | Active comparator | Biological: MenactraSubjects 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. |
Who may qualify
- Ages
- 2 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
- Written informed consent 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).
- Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
- Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
- Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration
Key exclusion criteria (20 listed)
- 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).
- 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).
- Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
- Current or previous, confirmed disease caused by Neisseria meningitidis.
- Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
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 |
|---|---|---|
| NmCV-5Also: MenACYWXPolyvalent 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. | Biological | NmCV-5 |
| MenactraAlso: MenACYW-DMenactra 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 | Biological | Menactra |
Primary outcome
Seroresponse
Time frame: 28 Days post vaccination
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].
Geometric mean titres
Time frame: 28 Days post vaccination
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29
5 secondary outcomes
Solicited adverse events
Time frame: 7 days post vaccination
Unsolicited adverse events
Time frame: 28 days post vaccination
Serious adverse events (SAEs)
Time frame: 6 months post vaccination
Seroprotective rSBA titres
Time frame: 28 days post vaccination
Long term protective rSBA titres
Time frame: 28 days post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Background: PubMed 30120069Chen 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.
- Derived from this study: PubMed 37256992Castilla J, Cenoz MG, Barricarte A. Meningococcal Group B Vaccine (4CMenB) in Children. Reply. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
- Derived from this study: PubMed 37256991Lopez-Lacort M, Munoz-Quiles C, Orrico-Sanchez A. Meningococcal Group B Vaccine (4CMenB) in Children. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
- Derived from this study: PubMed 37224196Haidara FC, Umesi A, Sow SO, Ochoge M, Diallo F, Imam A, Traore Y, Affleck L, Doumbia MF, Daffeh B, Kodio M, Wariri O, Traore A, Jallow E, Kampmann B, Kapse D, Kulkarni PS, Mallya A, Goel S, Sharma P, Sarma AD, Avalaskar N, LaForce FM, Alderson MR, Naficy A, Lamola S, Tang Y, Martellet L, Hosken N, Simeonidis E, Welsch JA, Tapia MD, Clarke E. Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. N Engl J Med. 2023 May 25;388(21):1942-1955. doi: 10.1056/NEJMoa2214924.
- Individual participant dataSharing planned: Undecided
Related trials for Meningococcal Meningitis
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NmCV-5 and Menactra in people with Meningococcal Meningitis, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
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 20 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali, The Gambia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seroresponse (time frame: 28 Days post vaccination). The study lists 2 primary outcomes in all. 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 NCT03964012, which also lists 4 linked publications.
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 27 Jul 2021.