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Streptococcus Pneumoniae InfectionPhase 3NCT05759520

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

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (multivalent conjugate) and Prevenar 13 in people with Streptococcus Pneumoniae Infection, run by Fosun Adgenvax Biopharmaceutical Co.,Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 6 weeks to 3 monthsHealthy volunteers can take part
Conditions the study is for
Streptococcus Pneumoniae Infection
What is being tested?
13-valent pneumococcal conjugate vaccine (multivalent conjugate) and Prevenar 13
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
5 sitesChina
Study dates
4 Nov 2022to 30 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks to 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Yizhou District Disease Prevention Control Center

    Hechi, Guangxi, 547000

  • Zhongshan County Center for Disease Control and Prevention

    Hezhou, Guangxi, 542800

  • Luzhai County Disease Prevention Control Center

    Liuzhou, Guangxi, 545000

  • Binyang County Center for Disease Control and Prevention

    Nanning, Guangxi, 530000

  • Wuming District Center for Disease Control and Prevention

    Nanning, Guangxi, 530000

Other trials in China

About this study

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

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.

Being tested
13-valent pneumococcal conjugate vaccine (multivalent conjugate), Prevenar 13
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13-valent pneumococcal conjugate vaccine (multivalent conjugate)Biological

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

  • Prevenar 13Biological

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

Study groups in NCT05759520
Study groupRoleWhat they receive
2-month-old experimental groupExperimentalVaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose)
Receives: Biological: 13-valent pneumococcal conjugate vaccine (multivalent conjugate)
2-month-old control groupActive comparatorVaccination of 4 doses of control vaccine(0,2,4,1 booster dose)
Receives: Biological: Prevenar 13
3-month-old groupExperimentalVaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose)
Receives: Biological: 13-valent pneumococcal conjugate vaccine (multivalent conjugate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies

    Immunogenicity

    Measured: 30 days after primary immunization

  2. 13 vaccine serotype-specific pneumococcal IgG antibodies GMC

    Immunogenicity

    Measured: 30 days after primary immunization

  3. incidence of adverse events (AE)

    Safety

    Measured: 30 minutes/0~7 days/0~30 days after each dose of vaccination

  4. incidence of all serious adverse events (SAEs)

    Safety

    Measured: from the first dose to 6 months after primary immunization

  5. incidence of all serious adverse events (SAEs)

    Safety

    Measured: from the first dose of vaccination to 12 months after the booster immunization

Secondary outcomes (9)

  1. percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml

    Primary stage

    Measured: 30 days after primary immunization

  2. the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes

    Primary stage

    Measured: 30 days after primary immunization

  3. the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes

    Primary stage

    Measured: 30 days after primary immunization

  4. the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes

    Primary stage

    Measured: 30 days after primary immunization

  5. seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies

    Booster stage

    Measured: 30 days after booster immunization

  6. percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL

    Booster stage

    Measured: 30 days after booster immunization

  7. GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies

    Booster stage

    Measured: 30 days after booster immunization

  8. the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes

    Booster stage

    Measured: 30 days after booster immunization

  9. the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes

    Booster stage

    Measured: 30 days after booster immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start4 Nov 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759520
Sponsor's protocol ID
ATG-PCV13-Ⅲ-2020001
Status last verified
Sep 2024
First submitted
26 Feb 2023
Last updated
1 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (multivalent conjugate) and Prevenar 13 in people with Streptococcus Pneumoniae Infection, run by Fosun Adgenvax Biopharmaceutical Co.,Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies (time frame: 30 days after primary immunization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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