Vaccine for Meningococcal DiseasePhase 2/3ACYWX-04NCT04358731
Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
A Phase 2/3 study testing NmCV-5 and Menactra in people with Vaccine for Meningococcal Disease, run by Serum Institute of India Pvt. Ltd. at 11 sites in India.
Trial summary
This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine for Meningococcal Disease
- What is being tested?
- NmCV-5 and Menactra
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- 11 sitesIndia
- Study dates
- 27 Dec 2019to 24 Mar 2021
- Phase
- Phase 2/3
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female 18 through 85 years of age, both inclusive, at the time of study vaccine administration.
- Provide written informed consent.
- The subject is resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
- Healthy, as determined by medical history and clinical assessment of the investigator.
- Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
Who cannot join
- Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject will be re-revaluated for eligibility).
- 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 90 days prior to vaccination.
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
Bangalore, Karnataka, 560004
M S Ramaiah Medical College and Hospitals, Bangalore
Bangalore, Karnataka, 560054
Institute of Medical Sciences and SUM Hospital Bhubaneshwar
Bhubaneswar, Odisha, 751003
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012
Sri Ramachandra Institute of Higher Education and Research
Chennai, Tamil Nadu, 600116
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, 400008
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, 400012
Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH) Jamia Hamdard, Hamdard Nagar, New Delhi - 110062
New Delhi, National Capital Territory of Delhi, 110062
Jahangir Clinical Development Centre Pvt. Ltd., Pune
Pune, Maharashtra, 411001
KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune
Pune, Maharashtra, 412216
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, 442102
About this study
Official title: A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra).
A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.
All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.
- Conditions
- Vaccine for Meningococcal Disease
- Being tested
- NmCV-5, Menactra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NmCV-5Biological
The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration.
The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine.
The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule.
MenactraBiological
The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.
| Study group | Role | What they receive |
|---|---|---|
| NmCV-5 | Experimental | A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years.
Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra.
The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.
Total 1230 subjects will be enrolled in NmCV-5 arm. Receives: Biological: NmCV-5 |
| Menactra | Active comparator | Subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra.
In Menactra arm, total 410 subjects will be enrolled. Receives: Biological: Menactra |
What is being measured
The primary outcome is the main question the study is designed to answer.
rSBA assay Geometric Mean Titers (GMTs) at Day 29 against serogroups A, C, W, Y and X in subjects 18 to 29 years of age.
Measured: 1 month after vaccination
Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
Measured: 28 days after immunization
Secondary outcomes (1)
rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.
Measured: Days 1 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start27 Dec 2019
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine for Meningococcal DiseaseStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Prasad Kulkarni, MD, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358731
- Sponsor's protocol ID
- ACYWX-04
- Acronym
- ACYWX-04
- Status last verified
- Mar 2021
- First submitted
- 20 Apr 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kulkarni PS, Kawade A, Kohli S, Munshi R, Maliye C, Gogtay NJ, S RH, Singh K, Vengadakrishnan K, Panigrahi SK, Sahoo J, Bavdekar A, Garg BS, Raut A, Raj JP, Saxena U, Chaudhari VL, Patil R, Venkatarao E, Kumari N, Surendran J, Parulekar V, Gagnon L, Gensale T, Dharmadhikari A, Gairola S, Kale S, Pisal SS, Dhere RM, Mallya A, Poonawalla CS, Kapse D. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study. Lancet Infect Dis. 2025 Apr;25(4):399-410. doi: 10.1016/S1473-3099(24)00576-0. Epub 2024 Nov 6.
PubMed 39521012
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
- ClinicalTrials.gov ID
- NCT04358731
- Acronym / sponsor ID
- ACYWX-04 / ACYWX-04
- Conditions
- Vaccine for Meningococcal Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,640 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 24 Apr 2020 (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 is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra).
A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.
All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.
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-5A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5. Total 1230 subjects will be enrolled in NmCV-5 arm. |
| Menactra | Active comparator | Biological: MenactraSubjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. In Menactra arm, total 410 subjects will be enrolled. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female 18 through 85 years of age, both inclusive, at the time of study vaccine administration.
- Provide written informed consent.
- The subject is resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
- Healthy, as determined by medical history and clinical assessment of the investigator.
- Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
Key exclusion criteria (5 listed)
- Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject will be re-revaluated for eligibility).
- 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 90 days prior to vaccination.
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
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-5The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration. The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine. The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule. | Biological | NmCV-5 |
| MenactraThe control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture. | Biological | Menactra |
Primary outcome
rSBA assay Geometric Mean Titers (GMTs) at Day 29 against serogroups A, C, W, Y and X in subjects 18 to 29 years of age.
Time frame: 1 month after vaccination
Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
Time frame: 28 days after immunization
1 secondary outcome
rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.
Time frame: Days 1 and 29
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 8 Sep 2021.
- Derived from this study: PubMed 39521012Kulkarni PS, Kawade A, Kohli S, Munshi R, Maliye C, Gogtay NJ, S RH, Singh K, Vengadakrishnan K, Panigrahi SK, Sahoo J, Bavdekar A, Garg BS, Raut A, Raj JP, Saxena U, Chaudhari VL, Patil R, Venkatarao E, Kumari N, Surendran J, Parulekar V, Gagnon L, Gensale T, Dharmadhikari A, Gairola S, Kale S, Pisal SS, Dhere RM, Mallya A, Poonawalla CS, Kapse D. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study. Lancet Infect Dis. 2025 Apr;25(4):399-410. doi: 10.1016/S1473-3099(24)00576-0. Epub 2024 Nov 6.
- Individual participant dataSharing planned: Yes
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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.
Dr Prasad Kulkarni, MD study director
Serum Institute of India Pvt. Ltd.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NmCV-5 and Menactra in people with Vaccine for Meningococcal Disease, run by Serum Institute of India Pvt. Ltd. at 11 sites in India.
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 5 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. 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 combined 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.
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?
rSBA assay Geometric Mean Titers (GMTs) at Day 29 against serogroups A, C, W, Y and X in subjects 18 to 29 years of age. (time frame: 1 month after 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 NCT04358731, 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 8 Sep 2021.