Clinical Trial of PCV24 in Infants Aged 2-23 Months

Official title

A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months

Overview

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.

Detailed description

A phase 1b clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese pediatric population aged 2 months (minimum 42 days)-23 months. The trial is a randomized, double-blind, positive controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13® manufactured by Pfizer.

A total of at least 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.

Interventions

• Biological Sinovac PCV24
  Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
• Biological Prevnar®
  Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Primary outcome measures

• Incidence of adverse reactions [Time frame: 0-30 days after vaccination]

Secondary outcome measures (6)

• Incidence of adverse reactions [Time frame: 0-7 days after vaccination]
• Incidence of serious adverse events (SAE) [Time frame: from vaccination to 6 months after final dose]
• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) [Time frame: 30 days after primary vaccination]
• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) [Time frame: 30 days after primary vaccination]
• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL [Time frame: 30 days after primary vaccination]
• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate) [Time frame: 30 days after primary vaccination]

Eligibility criteria

Inclusion criteria

• Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
• Participants' guardian provides legal identity document and participants' vaccination record;
• Participants' guardian understands and voluntarily signs the informed consent form;
• Follow all study procedures and stay in contact during the study.

Exclusion criteria

• Received any pneumococcal vaccine prior to enrollment;
• History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
• History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
• Low birth weight (<2.5kg), or premature infant (gestation weeks < 37 weeks) (applies to infants younger than 12 months);
• History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
• Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
• Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases.
• Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study.
• Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
• Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
• Received live attenuated vaccine within 14 days prior to enrollment;
• Received subunit or inactivated vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
• Axillary temperature≥ 37.3 Degree Celsius before vaccination;
• In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 2 centers

• Shandong Provincial Center for Disease Control and Prevention — Jinan
• Shanxian Center for Disease Control and Prevention — Shancheng

Identifiers

NCT: NCT06800261 · PRO-PCV24-1003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗