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

Primary Purpose

Streptococcus Pneumoniae Infection

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine (multivalent conjugate)
Prevenar 13
Sponsored by
Fosun Adgenvax Biopharmaceutical Co.,Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcus Pneumoniae Infection

Eligibility Criteria

6 Weeks - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Primary immunization phase: The subject's legal guardian voluntarily agreed to allow his child to participate in the study and signed an informed consent form. The subject's legal guardian has the ability to understand the study procedures and to participate in all planned follow-up visits. Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g. 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; Not having received a non-live vaccine within 7 days prior to enrollment and not having received a live vaccine within 14 days; The body temperature <37.5°C (axillary body temperature) on the day of enrollment. Booster immunization phase: Infants and children who have completed the full process of basic immunization in this clinical trial and are 12 to 15 months of age; 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: 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; 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); 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); 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); Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable); Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.; Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus; Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy; Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis; Asplenia, functional asplenia, and asplenia or splenectomy for any reason; 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: Subject received any other pneumonia vaccine after primary immunization and before booster immunization; Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization; 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; According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.

Sites / Locations

  • Yizhou District Disease Prevention Control CenterRecruiting
  • Zhongshan County Center for Disease Control and PreventionRecruiting
  • Luzhai County Disease Prevention Control CenterRecruiting
  • Binyang County Center for Disease Control and Prevention
  • Wuming District Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

2-month-old experimental group

2-month-old control group

3-month-old group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Immunogenicity
13 vaccine serotype-specific pneumococcal IgG antibodies GMC
Immunogenicity
incidence of adverse events (AE)
Safety
incidence of all serious adverse events (SAEs)
Safety
incidence of all serious adverse events (SAEs)
Safety

Secondary Outcome Measures

percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml
Primary stage
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Primary stage
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Booster stage
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL
Booster stage
GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies
Booster stage
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Booster stage
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Booster stage

Full Information

First Posted
February 26, 2023
Last Updated
February 26, 2023
Sponsor
Fosun Adgenvax Biopharmaceutical Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05759520
Brief Title
Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fosun Adgenvax Biopharmaceutical Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-month-old experimental group
Arm Type
Experimental
Arm Description
Vaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose)
Arm Title
2-month-old control group
Arm Type
Active Comparator
Arm Description
Vaccination of 4 doses of control vaccine(0,2,4,1 booster dose)
Arm Title
3-month-old group
Arm Type
Experimental
Arm Description
Vaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose)
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (multivalent conjugate)
Intervention Description
the 2-month-old experimental group and the 3-month-old group received the experimental vaccine
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Intervention Description
the 2-month-old control group received the active control vaccine
Primary Outcome Measure Information:
Title
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Description
Immunogenicity
Time Frame
30 days after primary immunization
Title
13 vaccine serotype-specific pneumococcal IgG antibodies GMC
Description
Immunogenicity
Time Frame
30 days after primary immunization
Title
incidence of adverse events (AE)
Description
Safety
Time Frame
30 minutes/0~7 days/0~30 days after each dose of vaccination
Title
incidence of all serious adverse events (SAEs)
Description
Safety
Time Frame
from the first dose to 6 months after primary immunization
Title
incidence of all serious adverse events (SAEs)
Description
Safety
Time Frame
from the first dose of vaccination to 12 months after the booster immunization
Secondary Outcome Measure Information:
Title
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml
Description
Primary stage
Time Frame
30 days after primary immunization
Title
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Description
Primary stage
Time Frame
30 days after primary immunization
Title
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Description
Primary stage
Time Frame
30 days after primary immunization
Title
the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Description
Primary stage
Time Frame
30 days after primary immunization
Title
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Description
Booster stage
Time Frame
30 days after booster immunization
Title
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL
Description
Booster stage
Time Frame
30 days after booster immunization
Title
GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies
Description
Booster stage
Time Frame
30 days after booster immunization
Title
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Description
Booster stage
Time Frame
30 days after booster immunization
Title
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Description
Booster stage
Time Frame
30 days after booster immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary immunization phase: The subject's legal guardian voluntarily agreed to allow his child to participate in the study and signed an informed consent form. The subject's legal guardian has the ability to understand the study procedures and to participate in all planned follow-up visits. Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g. 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; Not having received a non-live vaccine within 7 days prior to enrollment and not having received a live vaccine within 14 days; The body temperature <37.5°C (axillary body temperature) on the day of enrollment. Booster immunization phase: Infants and children who have completed the full process of basic immunization in this clinical trial and are 12 to 15 months of age; 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: 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; 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); 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); 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); Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable); Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.; Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus; Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy; Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis; Asplenia, functional asplenia, and asplenia or splenectomy for any reason; 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: Subject received any other pneumonia vaccine after primary immunization and before booster immunization; Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization; 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; According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianjing Wang
Phone
+86 02885155331
Email
wangtianjing@fosunpharma.com
Facility Information:
Facility Name
Yizhou District Disease Prevention Control Center
City
Hechi City
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
547000
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan County Center for Disease Control and Prevention
City
Hezhou City
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
542800
Country
China
Individual Site Status
Recruiting
Facility Name
Luzhai County Disease Prevention Control Center
City
Liuzhou City
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Name
Binyang County Center for Disease Control and Prevention
City
Nanning City
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530000
Country
China
Individual Site Status
Completed
Facility Name
Wuming District Center for Disease Control and Prevention
City
Nanning City
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530000
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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