VaccinePhase 3NCT03714737
Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese
A Phase 3 study testing experimental vaccine in people with Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention.
Trial summary
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA) and MenC in Asia, such as China. Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine
- What is being tested?
- experimental vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,950 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2016to 6 Sep 2018
- 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 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 months old group
- Healthy infants aged 3-5months old as established by medical history and clinical examination
- Subjects who was never administered meningococcal vaccine.
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature ≤37.0°C on axillary setting 6-23 months old group
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- Healthy infants aged 6-23 months old as established by medical history and clinical examination
- Subjects who was never administered meningococcal conjugate vaccine, or administered meningococcal polysaccharide vaccine over 3 months.
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature ≤37.0°C on axillary setting 2-5 years old group
- Healthy infants aged 2-5 years as established by medical history and clinical examination
- Subjects who was never administered meningococcal conjugate vaccine, or administered meningococcal polysaccharide vaccine over 12 months.
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature ≤37.0°C on axillary setting
Who cannot join
- Subjects who has a medical history of invasive meningococcal disease and meningococcal meningitis.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Severe malnutrition or dysgenopathy
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with injections or blood draws
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- Any acute infections in last 3 days
- Any prior administration of immunodepressant or corticosteroids in last 14 days
- Any prior administration of attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- If Subjects who have one condition as followed, prohibiting to continue the vaccination, and they will be continue observed in the opinion of the investigator. All participants with adverse events as followed, must be settled in follow-up to the end of events.
- Any serious adverse events caused by vaccination.
- Any confirmed or suspected autoimmune diseases or immune deficiency disorders, including human immunodeficiency virus (HIV) infection
- Have acute or new chronic disease during vaccination
- Other reactions that in the opinion of the investigator ( include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions )
About this study
Official title: Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese Healthy Children Aged 3 Months to 5 Years.: A Randomized, Blinded, Positive Controlled Phase III Clinical Trial
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA) and MenC in Asia, such as China. The specific vaccine use in each country depends on the predominant serogroups, cost, and availability. conjugate vaccines are preferred to polysaccharide vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and their overall increased immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.
Read the detailed description
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA), MenB, MenC, MenW and MenY. Their prevalence varies geographically, MenA and MenC being more prominent in Asia. Neisseria meningitidis is one of the leading causes of bacterial meningitis globally. The annual number of cases related to invasive meningococcal disease (IMD) is estimated to be at least 1.2 million with 135 000 deaths.1 To combat IMD, an increasing number of countries have included vaccines against N. meningitidis in their routine immunization programs. The specific vaccine use in each country depends on the predominant serogroups, cost, and availability. Polysaccharide vaccines were used in high risk people in Saudi Arabia and Syria and in routine immunization in China and Egypt. In general, conjugate vaccines are preferred to polysaccharide vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and their overall increased immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.
- Conditions
- Vaccine
- Being tested
- experimental vaccine, Positive control vaccine 1, Positive control vaccine 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental vaccineBiological
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
Positive control vaccine 1Biological
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)
Positive control vaccine 2Biological
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Experimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0. Receives: Biological: experimental vaccine |
| Positive control 1 | Active comparator | Positive control vaccine 1 of 0.5ml in 300 children aged 2-5 years at day 0. Receives: Biological: Positive control vaccine 1 |
| Experimental 2 | Experimental | Experimental vaccine of 0.5ml in 150 children aged 12-23 months at day 0 and 28. Receives: Biological: experimental vaccine |
| Experimental 3 | Experimental | Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0. Receives: Biological: experimental vaccine |
| Positive control 2 | Active comparator | Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0 and 28. Receives: Biological: Positive control vaccine 2 |
| Experimental 4 | Experimental | Experimental vaccine of 0.5ml in 150 children aged 2-5 years at day 0 and 28, and boost at 18 months. Receives: Biological: experimental vaccine |
| Positive Control 3 | Active comparator | Positive control vaccine 2 of 0.5ml in 150 children aged 6-11 months at day 0 and 28. Receives: Biological: Positive control vaccine 2 |
| Experimental 5 | Experimental | Experimental vaccine of 0.5ml in 300 children aged 3-5 months at day 0, 28, 56, and boost at 18 months. Receives: Biological: experimental vaccine |
| Positive Control 4 | Active comparator | Positive control vaccine 1 of 0.5ml in 300 children aged 3-5 months day 0, 28, 56. Receives: Biological: Positive control vaccine 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rates of antibodies after vaccination
seroconversion rates of antibodies against meningococcal serogroups A and C
Measured: 28 days after vaccination
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions within 7 days post-each dose
Measured: Day 7 post-each dose
Secondary outcomes (6)
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 2-5 years.
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C at day 28 post vaccination in children aged 2-5 years.
Measured: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 12-23 months.
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 12-23 months with two vaccination schedules.
Measured: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 6-11 months.
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 6-11 months.
Measured: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 3-5 months.
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 3-5 months.
Measured: 28 days after vaccination
Proportion of subjects reporting unsolicited adverse events
Proportion of subjects reporting unsolicited adverse events
Measured: 28 days after vaccination
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start12 May 2016
- Primary completion11 Sep 2017
- Study completion6 Sep 2018
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 VaccineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714737
- Sponsor's protocol ID
- JSVCT028
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu J, Li H, Chu K, Liang Q, Li J, Luo L, Hu Y, Meng F, Zhu F. Immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT): two immune schedules in toddles aged 12-23 months in China. Hum Vaccin Immunother. 2019;15(12):2952-2959. doi: 10.1080/21645515.2019.1627816. Epub 2019 Jul 26.
PubMed 31348731
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese Healthy Children Aged 3 Months to 5 Years.: A Randomized, Blinded, Positive Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT03714737
- Acronym / sponsor ID
- JSVCT028
- Conditions
- Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,950 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 12 May 2016 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 22 Oct 2018 (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.
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA) and MenC in Asia, such as China. The specific vaccine use in each country depends on the predominant serogroups, cost, and availability. conjugate vaccines are preferred to polysaccharide vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and their overall increased immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.
Detailed description
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA), MenB, MenC, MenW and MenY. Their prevalence varies geographically, MenA and MenC being more prominent in Asia. Neisseria meningitidis is one of the leading causes of bacterial meningitis globally. The annual number of cases related to invasive meningococcal disease (IMD) is estimated to be at least 1.2 million with 135 000 deaths.1 To combat IMD, an increasing number of countries have included vaccines against N. meningitidis in their routine immunization programs. The specific vaccine use in each country depends on the predominant serogroups, cost, and availability. Polysaccharide vaccines were used in high risk people in Saudi Arabia and Syria and in routine immunization in China and Egypt. In general, conjugate vaccines are preferred to polysaccharide vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and their overall increased immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Biological: experimental vaccineExperimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0. |
| Positive control 1 | Active comparator | Biological: Positive control vaccine 1Positive control vaccine 1 of 0.5ml in 300 children aged 2-5 years at day 0. |
| Experimental 2 | Experimental | Biological: experimental vaccineExperimental vaccine of 0.5ml in 150 children aged 12-23 months at day 0 and 28. |
| Experimental 3 | Experimental | Biological: experimental vaccinePositive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0. |
| Positive control 2 | Active comparator | Biological: Positive control vaccine 2Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0 and 28. |
| Experimental 4 | Experimental | Biological: experimental vaccineExperimental vaccine of 0.5ml in 150 children aged 2-5 years at day 0 and 28, and boost at 18 months. |
| Positive Control 3 | Active comparator | Biological: Positive control vaccine 2Positive control vaccine 2 of 0.5ml in 150 children aged 6-11 months at day 0 and 28. |
| Experimental 5 | Experimental | Biological: experimental vaccineExperimental vaccine of 0.5ml in 300 children aged 3-5 months at day 0, 28, 56, and boost at 18 months. |
| Positive Control 4 | Active comparator | Biological: Positive control vaccine 1Positive control vaccine 1 of 0.5ml in 300 children aged 3-5 months day 0, 28, 56. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 3-5 months old group
- Healthy infants aged 3-5months old as established by medical history and clinical examination
- Subjects who was never administered meningococcal vaccine.
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
Key exclusion criteria (17 listed)
- Subjects who has a medical history of invasive meningococcal disease and meningococcal meningitis.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Severe malnutrition or dysgenopathy
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
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 |
|---|---|---|
| experimental vaccinebivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD) | Biological | Experimental 1, Experimental 2, Experimental 3, Experimental 4, Experimental 5 |
| Positive control vaccine 1bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD) | Biological | Positive Control 4, Positive control 1 |
| Positive control vaccine 2bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD) | Biological | Positive Control 3, Positive control 2 |
Primary outcome
seroconversion rates of antibodies after vaccination
Time frame: 28 days after vaccination
seroconversion rates of antibodies against meningococcal serogroups A and C
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions
Time frame: Day 7 post-each dose
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions within 7 days post-each dose
6 secondary outcomes
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 2-5 years.
Time frame: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 12-23 months.
Time frame: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 6-11 months.
Time frame: 28 days after vaccination
Percentage of rSBA titers ≥1:128 and ≥1:8, and GMT for meningococcal serogroups A and C after vaccination in children aged 3-5 months.
Time frame: 28 days after vaccination
Proportion of subjects reporting unsolicited adverse events
Time frame: 28 days after vaccination
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time frame: 28 days after 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 22 Oct 2018.
- Derived from this study: PubMed 31348731Hu J, Li H, Chu K, Liang Q, Li J, Luo L, Hu Y, Meng F, Zhu F. Immunogenicity and safety of a meningococcal serogroups A and C tetanus toxoid conjugate vaccine (MenAC-TT): two immune schedules in toddles aged 12-23 months in China. Hum Vaccin Immunother. 2019;15(12):2952-2959. doi: 10.1080/21645515.2019.1627816. Epub 2019 Jul 26.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing experimental vaccine in people with Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention.
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 16 inclusion and 17 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
seroconversion rates of antibodies after vaccination (time frame: 28 days 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 NCT03714737, 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 22 Oct 2018.