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

September 27, 2024 updated by: Fosun Adgenvax Biopharmaceutical Co.,Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi Zhuang Autonomous Region
      • Hechi City, Guangxi Zhuang Autonomous Region, China, 547000
        • Yizhou District Disease Prevention Control Center
      • Hezhou City, Guangxi Zhuang Autonomous Region, China, 542800
        • Zhongshan County Center for Disease Control and Prevention
      • Liuzhou City, Guangxi Zhuang Autonomous Region, China, 545000
        • Luzhai County Disease Prevention Control Center
      • Nanning City, Guangxi Zhuang Autonomous Region, China, 530000
        • Binyang County Center for Disease Control and Prevention
      • Nanning City, Guangxi Zhuang Autonomous Region, China, 530000
        • Wuming District Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2-month-old experimental group
Vaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose)
Biological: 13-valent pneumococcal conjugate vaccine (multivalent conjugate)
the 2-month-old experimental group and the 3-month-old group received the experimental vaccine
Active Comparator: 2-month-old control group
Vaccination of 4 doses of control vaccine(0,2,4,1 booster dose)
Biological: Prevenar 13
the 2-month-old control group received the active control vaccine
Experimental: 3-month-old group
Vaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose)
Biological: 13-valent pneumococcal conjugate vaccine (multivalent conjugate)
the 2-month-old experimental group and the 3-month-old group received the experimental vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Time Frame: 30 days after primary immunization
Immunogenicity
30 days after primary immunization
13 vaccine serotype-specific pneumococcal IgG antibodies GMC
Time Frame: 30 days after primary immunization
Immunogenicity
30 days after primary immunization
incidence of adverse events (AE)
Time Frame: 30 minutes/0~7 days/0~30 days after each dose of vaccination
Safety
30 minutes/0~7 days/0~30 days after each dose of vaccination
incidence of all serious adverse events (SAEs)
Time Frame: from the first dose to 6 months after primary immunization
Safety
from the first dose to 6 months after primary immunization
incidence of all serious adverse events (SAEs)
Time Frame: from the first dose of vaccination to 12 months after the booster immunization
Safety
from the first dose of vaccination to 12 months after the booster immunization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml
Time Frame: 30 days after primary immunization
Primary stage
30 days after primary immunization
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Time Frame: 30 days after primary immunization
Primary stage
30 days after primary immunization
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Time Frame: 30 days after primary immunization
Primary stage
30 days after primary immunization
the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Time Frame: 30 days after primary immunization
Primary stage
30 days after primary immunization
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
Time Frame: 30 days after booster immunization
Booster stage
30 days after booster immunization
percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL
Time Frame: 30 days after booster immunization
Booster stage
30 days after booster immunization
GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies
Time Frame: 30 days after booster immunization
Booster stage
30 days after booster immunization
the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes
Time Frame: 30 days after booster immunization
Booster stage
30 days after booster immunization
the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes
Time Frame: 30 days after booster immunization
Booster stage
30 days after booster immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fosun Adgenvax Biopharmaceutical Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATG-PCV13-Ⅲ-2020001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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