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

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

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

NCT05759520•Fosun Adgenvax Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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;
+7 more criteria

Locations (5)

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

Liuchow, Guangxi, China

Binyang County Center for Disease Control and Prevention

Nanning, Guangxi, China

Wuming District Center for Disease Control and Prevention

Nanning, Guangxi, China

Key Dates

Start Date

November 4, 2022

Primary Completion Date

June 30, 2025

Completion Date

June 30, 2025

Last Updated

October 1, 2024

Enrollment

1,800

ESTIMATED participants

Conditions

Streptococcus Pneumoniae Infection

Interventions

13-valent pneumococcal conjugate vaccine (multivalent conjugate)

BIOLOGICAL

Prevenar 13

BIOLOGICAL

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Streptococcus Pneumoniae InfectionLegionella Pneumophila Serogroup 1 Infection

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COMPLETED

Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

NCT03696303

Community-acquired PneumoniaStreptococcus Pneumoniae Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

Pneumococcal Nasopharyngeal Colonization as Predictor of Community-Acquired Pneumonia (CAP) in Adults With Chronic Diseases.

Nasopharyngeal Streptococcus Pneumoniae Carriage