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

Streptococcus Pneumoniae Infection Clinical Trial

Official title:

Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants Aged 2 Months (at Least 6 Weeks) and 3 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759520
• Other study ID #: ATG-PCV13-?-2020001
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2023
• Source: Fosun Adgenvax Biopharmaceutical Co.,Ltd.
• Contact: Tianjing Wang
• Phone: +86 02885155331
• Email: wangtianjing[@]fosunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Infections
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae Infection

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine (multivalent conjugate)
the 2-month-old experimental group and the 3-month-old group received the experimental vaccine
• Prevenar 13
the 2-month-old control group received the active control vaccine

Locations

Country	Name	City	State
China	Yizhou District Disease Prevention Control Center	Hechi City	Guangxi Zhuang Autonomous Region
China	Zhongshan County Center for Disease Control and Prevention	Hezhou City	Guangxi Zhuang Autonomous Region
China	Luzhai County Disease Prevention Control Center	Liuzhou City	Guangxi Zhuang Autonomous Region
China	Binyang County Center for Disease Control and Prevention	Nanning City	Guangxi Zhuang Autonomous Region
China	Wuming District Center for Disease Control and Prevention	Nanning City	Guangxi Zhuang Autonomous Region

Sponsors (1)

Lead Sponsor	Collaborator
Fosun Adgenvax Biopharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies	Immunogenicity	30 days after primary immunization
Primary	13 vaccine serotype-specific pneumococcal IgG antibodies GMC	Immunogenicity	30 days after primary immunization
Primary	incidence of adverse events (AE)	Safety	30 minutes/0~7 days/0~30 days after each dose of vaccination
Primary	incidence of all serious adverse events (SAEs)	Safety	from the first dose to 6 months after primary immunization
Primary	incidence of all serious adverse events (SAEs)	Safety	from the first dose of vaccination to 12 months after the booster immunization
Secondary	percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations =1.0 µg/ml	Primary stage	30 days after primary immunization
Secondary	the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes	Primary stage	30 days after primary immunization
Secondary	the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes	Primary stage	30 days after primary immunization
Secondary	the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes	Primary stage	30 days after primary immunization
Secondary	seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies	Booster stage	30 days after booster immunization
Secondary	percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations = 1.0 µg/mL	Booster stage	30 days after booster immunization
Secondary	GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies	Booster stage	30 days after booster immunization
Secondary	the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes	Booster stage	30 days after booster immunization
Secondary	the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes	Booster stage	30 days after booster immunization