> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-immunogenicity-study-of-a-13-valent-pneumococcal-1961bc09-a613-410f-942c-92525a33eae1
> Record changed: 2026-10-13

# Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT05092386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Participants

310

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Lead sponsor

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Start date

2023-01-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Title and summary

**Summary**

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \\& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Short title**

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Official title**

An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Dates

**Completion date**

2024-05-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**First posted**

2021-10-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Registry last updated**

2026-01-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Primary completion date**

2024-05-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Start date**

2023-01-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Size and sites

**Actual participants**

310

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Participants**

310

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Lead sponsor**

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Identifiers

**Registry ID**

NCT05092386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**ClinicalTrials.gov ID**

NCT05092386

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Double masking

**Masking description**

Open label design will be adopted for children and adolescents aged 6-17 years and infants aged 3 months, and randomized, blind and positive control design was adopted for other populations

**Masked roles**

Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Outcomes

### Primary outcomes

1. Safety index-incidence of adverse reactions  
Timeframe: Day 0-30 after each dose of experimental vaccine  
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine

### Secondary outcomes

1. Safety index-incidence of adverse reactions  
Timeframe: Day 0-7 after each dose of experimental vaccine  
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
2. Safety index-incidence of abnormal indicators  
Timeframe: Day 3 after vaccination after each dose of experimental vaccine  
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
3. Safety index-Incidence of serious adverse events during the safety observation period  
Timeframe: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization  
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
4. Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype  
Timeframe: Day 30 after vaccination  
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
5. Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype  
Timeframe: Day 30 after vaccination  
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
6. Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody  
Timeframe: Day 30 after vaccination  
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
7. Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)  
Timeframe: Day 30 after vaccination  
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
8. Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)  
Timeframe: Day 30 before and after booster immunization  
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 \\\~ 11 months at 30 days before and after booster immunization
9. Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)  
Timeframe: Day 30 before and after booster immunization  
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7\\\~ 11 months at 30 days before and after booster immunization

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults

**Minimum age**

6 Weeks

**Maximum age**

49 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 \~ 11 months, healthy infants aged 12\~ 23 months, healthy children aged 2\~ 5 years, healthy adolescent and children aged 6\~ 17 years, healthy adults aged 18\~ 49 years；
- Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
- The subject and/or guardian can understand and voluntarily sign the informed consent form.

### Exclusion criteria

- Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
- Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
- History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Sites

- Henan Center for Diseases Control and PreventionZhengzhou, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05092386)

## Related records

### Drugs (1)

- [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md)

### Lead sponsors (1)

- [Sinovac Life Sciences Co., Ltd.](https://trialight.com/data/company/sinovac-life-sciences-co-ltd-d3dbe3ae-1264-4328-a691-a71dbc1efbbc.md)

### Conditions (1)

- [Pneumococcal infection](https://trialight.com/data/condition/pneumococcal-infection-b3a7fc66-25ac-57f8-8fb4-073403fe8b1b.md) Primary condition

### Targets (1)

- [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md)

---

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