Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants

NCT ID: NCT05759520

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2025-06-30

Brief Summary

This study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.

Conditions

Streptococcus Pneumoniae Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

2-month-old experimental group

Vaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose)

Group Type: EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (multivalent conjugate)

Intervention Type: BIOLOGICAL

the 2-month-old experimental group and the 3-month-old group received the experimental vaccine

2-month-old control group

Vaccination of 4 doses of control vaccine(0,2,4,1 booster dose)

Group Type: ACTIVE_COMPARATOR

Prevenar 13

Intervention Type: BIOLOGICAL

the 2-month-old control group received the active control vaccine

3-month-old group

Vaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose)

Group Type: EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (multivalent conjugate)

Intervention Type: BIOLOGICAL

the 2-month-old experimental group and the 3-month-old group received the experimental vaccine

Interventions

13-valent pneumococcal conjugate vaccine (multivalent conjugate)

the 2-month-old experimental group and the 3-month-old group received the experimental vaccine

Intervention Type: BIOLOGICAL

Prevenar 13

the 2-month-old control group received the active control vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Primary immunization phase:

1. The subject's legal guardian voluntarily agreed to allow his child to participate in the study and signed an informed consent form.

2. The subject's legal guardian has the ability to understand the study procedures and to participate in all planned follow-up visits.

3. Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g.

4. On the day of the first dose of vaccination, it meets the observation age of this clinical trial (2~3 months of age, with a minimum of 6 weeks) and be able to provide legal identification;

5. Not having received a non-live vaccine within 7 days prior to enrollment and not having received a live vaccine within 14 days;

6. The body temperature <37.5°C (axillary body temperature) on the day of enrollment.

Booster immunization phase:

1. Infants and children who have completed the full process of basic immunization in this clinical trial and are 12 to 15 months of age;

2. According to the opinion of the investigator, the subject's legal guardians and their families can comply with the requirements of the clinical trial protocol.

Exclusion Criteria

Primary immunization phase:

1. The baby is born in abnormal labor (dystocia, instrumental delivery) or has a history of asphyxia and nervous system damage, and is now suffering from pathologic jaundice, perianal abscess and severe eczema;

2. Have been vaccinated against pneumococcus in the past or have a history of invasive diseases caused by pneumococcus in the past (confirmed by either clinical, serological or microbiological methods);

3. Previous history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura and local allergic necrosis reaction (Arthus reaction);

4. Suffering from congenital or acquired immunodeficiency, or receiving immunosuppressant treatment, such as systemic glucocorticoid treatment for more than 2 weeks one month before vaccination, such as prednisone or similar drugs > 5mg/day (use of local and inhaled/atomized steroids is eligible for enrollment);

5. Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable);

6. Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.;

7. Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus;

8. Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;

9. Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis;

10. Asplenia, functional asplenia, and asplenia or splenectomy for any reason;

11. Subjects with other safety risks or conditions that, in the opinion of the investigator, may interfere with the assessment of the purpose of the study.

Booster immunization phase:

1. Subject received any other pneumonia vaccine after primary immunization and before booster immunization;

2. Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization;

3. The subjects have known or suspected immunological functional defects since they participated in this clinical trial, including receiving immunosuppressant treatment (such as systemic glucocorticoid treatment for more than 2 weeks in one month before vaccination, such as prednisone or similar drugs > 5mg/day) and their parents are HIV-infected;

4. According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fosun Adgenvax Biopharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yizhou District Disease Prevention Control Center

Hechi, Guangxi, China

Zhongshan County Center for Disease Control and Prevention

Hezhou, Guangxi, China

Luzhai County Disease Prevention Control Center

Liuzhou, Guangxi, China

Binyang County Center for Disease Control and Prevention

Nanning, Guangxi, China

Wuming District Center for Disease Control and Prevention

Nanning, Guangxi, China

Countries

China

Other Identifiers

ATG-PCV13-Ⅲ-2020001

Identifier Type: -

Identifier Source: org_study_id