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Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese

Primary Purpose

Vaccine

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

experimental vaccine

Positive control vaccine 1

Positive control vaccine 2

About this trial

This is an interventional prevention trial for Vaccine

Eligibility Criteria

3 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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 )

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Experimental 1

Positive control 1

Experimental 2

Experimental 3

Positive control 2

Experimental 4

Positive Control 3

Experimental 5

Positive Control 4

Arm Description

Experimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0.

Positive control vaccine 1 of 0.5ml in 300 children aged 2-5 years at day 0.

Experimental vaccine of 0.5ml in 150 children aged 12-23 months at day 0 and 28.

Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0.

Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0 and 28.

Experimental vaccine of 0.5ml in 150 children aged 2-5 years at day 0 and 28, and boost at 18 months.

Positive control vaccine 2 of 0.5ml in 150 children aged 6-11 months at day 0 and 28.

Experimental vaccine of 0.5ml in 300 children aged 3-5 months at day 0, 28, 56, and boost at 18 months.

Positive control vaccine 1 of 0.5ml in 300 children aged 3-5 months day 0, 28, 56.

Outcomes

Primary Outcome Measures

seroconversion rates of antibodies after vaccination

seroconversion rates of antibodies against meningococcal serogroups A and C

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

Secondary Outcome Measures

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.

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.

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 3-5 months.

Proportion of subjects reporting unsolicited adverse events

Proportion of subjects with Serious Adverse Events occurring throughout the trial

Full Information

NCT ID

NCT03714737

First Posted

October 17, 2018

Last Updated

October 18, 2018

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03714737

Brief Title

Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 12, 2016 (Actual)

Primary Completion Date

September 11, 2017 (Actual)

Study Completion Date

September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1950 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental 1

Arm Type

Experimental

Arm Description

Experimental vaccine of 0.5ml in 300 children aged 2-5 years at day 0.

Arm Title

Positive control 1

Arm Type

Active Comparator

Arm Description

Positive control vaccine 1 of 0.5ml in 300 children aged 2-5 years at day 0.

Arm Title

Experimental 2

Arm Type

Experimental

Arm Description

Experimental vaccine of 0.5ml in 150 children aged 12-23 months at day 0 and 28.

Arm Title

Experimental 3

Arm Type

Experimental

Arm Description

Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0.

Arm Title

Positive control 2

Arm Type

Active Comparator

Arm Description

Positive control vaccine 2 of 0.5ml in 150 children aged 12-23 months at day 0 and 28.

Arm Title

Experimental 4

Arm Type

Experimental

Arm Description

Experimental vaccine of 0.5ml in 150 children aged 2-5 years at day 0 and 28, and boost at 18 months.

Arm Title

Positive Control 3

Arm Type

Active Comparator

Arm Description

Positive control vaccine 2 of 0.5ml in 150 children aged 6-11 months at day 0 and 28.

Arm Title

Experimental 5

Arm Type

Experimental

Arm Description

Experimental vaccine of 0.5ml in 300 children aged 3-5 months at day 0, 28, 56, and boost at 18 months.

Arm Title

Positive Control 4

Arm Type

Active Comparator

Arm Description

Positive control vaccine 1 of 0.5ml in 300 children aged 3-5 months day 0, 28, 56.

Intervention Type

Biological

Intervention Name(s)

experimental vaccine

Intervention Description

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)

Intervention Type

Biological

Intervention Name(s)

Positive control vaccine 1

Intervention Description

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)

Intervention Type

Biological

Intervention Name(s)

Positive control vaccine 2

Intervention Description

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)

Primary Outcome Measure Information:

Title

seroconversion rates of antibodies after vaccination

Description

seroconversion rates of antibodies against meningococcal serogroups A and C

Time Frame

28 days after vaccination

Title

Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions

Description

Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions within 7 days post-each dose

Time Frame

Day 7 post-each dose

Secondary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

28 days after vaccination

Title

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.

Description

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.

Time Frame

28 days after vaccination

Title

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.

Description

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

Title

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.

Description

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

Title

Proportion of subjects reporting unsolicited adverse events

Description

Proportion of subjects reporting unsolicited adverse events

Time Frame

28 days after vaccination

Title

Proportion of subjects with Serious Adverse Events occurring throughout the trial

Description

Proportion of subjects with Serious Adverse Events occurring throughout the trial

Time Frame

28 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 )

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31348731

Citation

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.

Results Reference

derived

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Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese

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