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

NCT03714737 | Completed Phase 3

• 1 other identifier: JSVCT028
• Study Type: interventional
• Target: 1,950
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Vaccine

Outcome Measures

Primary Outcomes (2)

• seroconversion rates of antibodies 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

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

  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.

  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.

  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.

  28 days after vaccination

• Proportion of subjects reporting unsolicited adverse events

  28 days after vaccination

Study Arms (9)

Experimental 1

EXPERIMENTAL

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

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.

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.

Biological: experimental vaccine

Experimental 3

EXPERIMENTAL

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

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.

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.

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.

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.

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.

Biological: Positive control vaccine 1

Interventions

experimental vaccine BIOLOGICAL

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

Experimental 1; Experimental 2; Experimental 3; Experimental 4; Experimental 5

Positive control vaccine 1 BIOLOGICAL

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

Positive Control 4; Positive control 1

Positive control vaccine 2 BIOLOGICAL

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

Positive Control 3; Positive control 2

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Related Publications (1)

• 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.

  PMID: 31348731 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: May 12, 2016
• Primary Completion: September 11, 2017
• Study Completion: September 6, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share