Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months

NCT06314659 | Active Not Recruiting Phase 3

• 1 other identifier: 2020020C
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old.

Conditions

Healthy Population

Keywords

Group A and C Meningococcal Polysaccharide Conjugate Vaccine

Outcome Measures

Primary Outcomes (2)

• Analysis of antibody positivity conversion rate of serogroup A

  The proportion of people with pre-immunization antibody titer against serogroup A meningococcus \<1:8 who achieve an antibody titer ≥1:8 after immunization.

  30 day after primary immunization

• Analysis of antibody positivity conversion rate of serogroup C

  The proportion of people with pre-immunization antibody titer against serogroup C meningococcus \<1:8 who achieve an antibody titer ≥1:8 after immunization.

  30 day after primary immunization

Study Arms (2)

Basic immunization

EXPERIMENTAL

Perform basic immunization with a program of 0, 1, and 2 months, booster vaccination with 1 dose at 18 months of age.

Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu); Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax)

Booster immunization

ACTIVE COMPARATOR

Perform booster vaccination with 1 dose at 18 months of age.

Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu); Biological: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax)

Interventions

Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu) BIOLOGICAL

Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months and booster immunization at 18 months of age.

Basic immunization; Booster immunization

Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax) BIOLOGICAL

Performed primary immunization following a 0-1-2-month schedule at the aged from 3 to 5 months.

Basic immunization

Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax) BIOLOGICAL

Performed booster immunization at 18 months of age.

Booster immunization

Eligibility Criteria

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

You may qualify if:

• For primary immunization stage
• Subjects aged 3-5 months;
• Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
• Axillary body temperature ≤ 37.0 ℃;
• The guardian signs the informed consent form;
• The guardian and his family agree to comply with the requirements of the clinical trial protocol;
• Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine;
• Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
• For booster immunization and immune persistence stage
• Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
• Infants and young children who have completed primary or booster immunization in this clinical trial;
• According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

You may not qualify if:

• For primary immunization stage
• Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
• History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
• A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
• History of severe abnormal labor and delivery, asphyxia rescue, congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
• Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), serious liver and kidney diseases, and diabetes with complications;
• Has been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
• History or family history of encephalopathy, epilepsy, convulsions or seizures, and other progressive neurological diseases;
• Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before vaccination;
• Long term treatment with immunosuppressants, such as long-term (continuous for more than 2 weeks) use of glucocorticoids (such as prednisone or inhaled steroids (budesonide, fluticasone) and similar drugs);
• History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
• Plan to participate or be participating in any other drug clinical research;
• Plan to move out of the local area before the end of the study or leave for a long time during the scheduled study visit period;
• According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
• For booster immunization and immune persistence stage

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530028, China

Location

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: September 17, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

CN (1)