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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1950

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental 1
Experimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0.
Biological: experimental vaccine
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.
Biological: Positive control vaccine 1
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.
Biological: experimental vaccine
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.
Biological: experimental vaccine
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.
Biological: Positive control vaccine 2
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.
Biological: experimental vaccine
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.
Biological: Positive control vaccine 2
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.
Biological: experimental vaccine
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.
Biological: Positive control vaccine 1
bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province Centers for Disease Control and Prevention

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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