- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03714737
Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese
October 18, 2018 updated by: Jiangsu Province Centers for Disease Control and Prevention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1950
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 5 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Exclusion Criteria for the second and third dose:
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 )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental 1
Experimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
|
ACTIVE_COMPARATOR: Positive control 1
Positive control vaccine 1 of 0.5ml in 300 children aged 2-5 years at day 0.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)
|
EXPERIMENTAL: Experimental 2
Experimental vaccine of 0.5ml in 150 children aged 12-23 months at day 0 and 28.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
|
EXPERIMENTAL: Experimental 3
Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
|
ACTIVE_COMPARATOR: Positive control 2
Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0 and 28.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)
|
EXPERIMENTAL: Experimental 4
Experimental vaccine of 0.5ml in 150 children aged 2-5 years at day 0 and 28, and boost at 18 months.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
|
ACTIVE_COMPARATOR: Positive Control 3
Positive control vaccine 2 of 0.5ml in 150 children aged 6-11 months at day 0 and 28.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)
|
EXPERIMENTAL: Experimental 5
Experimental vaccine of 0.5ml in 300 children aged 3-5 months at day 0, 28, 56, and boost at 18 months.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
|
ACTIVE_COMPARATOR: Positive Control 4
Positive control vaccine 1 of 0.5ml in 300 children aged 3-5 months day 0, 28, 56.
|
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
seroconversion rates of antibodies after vaccination
Time Frame: 28 days after vaccination
|
seroconversion rates of antibodies against meningococcal serogroups A and C
|
28 days after vaccination
|
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
|
Day 7 post-each dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 at day 28 post vaccination in children aged 2-5 years.
|
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 12-23 months with two vaccination schedules.
|
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 6-11 months.
|
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
|
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.
|
28 days after vaccination
|
Proportion of subjects reporting unsolicited adverse events
Time Frame: 28 days after vaccination
|
Proportion of subjects reporting unsolicited adverse events
|
28 days after vaccination
|
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time Frame: 28 days after vaccination
|
Proportion of subjects with Serious Adverse Events occurring throughout the trial
|
28 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 12, 2016
Primary Completion (ACTUAL)
September 11, 2017
Study Completion (ACTUAL)
September 6, 2018
Study Registration Dates
First Submitted
October 17, 2018
First Submitted That Met QC Criteria
October 18, 2018
First Posted (ACTUAL)
October 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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