> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/clinical-trial-of-pcv24-in-adults-a81ded8a-d588-48df-9084-16ad4fce341b
> Record changed: 2026-10-13

# Clinical Trial of PCV24 in Adults

NCT06474377

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Participants

170

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Lead sponsor

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Start date

2024-06-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Title and summary

**Summary**

A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in adults aged 18 years and older. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24\. The trial is a randomized, double-blind, controlled Phase I clinical trial.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Short title**

Clinical Trial of PCV24 in Adults

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Official title**

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Dates

**Completion date**

2025-02-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**First posted**

2024-06-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Registry last updated**

2025-04-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Primary completion date**

2024-08-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Start date**

2024-06-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Size and sites

**Actual participants**

170

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Participants**

170

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Randomisation ratio**

2:2:2:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Lead sponsor**

Sinovac Life Sciences Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Identifiers

**Registry ID**

NCT06474377

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**ClinicalTrials.gov ID**

NCT06474377

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Outcomes

### Primary outcomes

1. Incidence of adverse reactions  
Timeframe: 0-30 days after vaccination  
Incidence of adverse reactions within 30 days after vaccination

### Secondary outcomes

1. Incidence of adverse reactions  
Timeframe: 0-7 days after vaccination  
Incidence of adverse reactions within 7 days after vaccination
2. Incidence of serious adverse events (SAE)  
Timeframe: 0-6 months after vaccination  
Incidence of SAE during the period of safety monitoring
3. Incidence of clinically significant abnormality in laboratory examination tests  
Timeframe: 0-3 days after vaccination  
Incidence of clinically significant abnormality in blood routine, blood biochemistry and urine routine test results within 3 days after vaccination
4. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)  
Timeframe: 30 days after vaccination  
IgG GMC 30 days after vaccination
5. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)  
Timeframe: 30 days after vaccination  
IgG GMI 30 days after vaccination
6. Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4  
Timeframe: 30 days after vaccination  
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
7. Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)  
Timeframe: 30 days after vaccination  
OPA GMT 30 days after vaccination
8. Pneumococcal serotype-specific OPA GMI  
Timeframe: 30 days after vaccination  
OPA GMI 30 days after vaccination
9. Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4  
Timeframe: 30 days after vaccination  
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

Yes

### Inclusion criteria

1. Healthy volunteers who are aged 18 years and older, and provide legal proof of identity;
2. Participants understand and voluntarily sign the informed consent form;
3. Participants can follow all study procedures and stay in contact during the study.

### Exclusion criteria

1. Received any pneumococcal vaccine prior to enrollment;
2. History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
4. Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
5. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as hypertension uncontrolled by drugs (measurement on site: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) and coronary heart disease, metabolic diseases (such as uncontrolled diabetes), hematological diseases (e.g. severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
6. Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
7. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
9. Long-term alcohol or drug abuse.
10. Have received > 14 days of immunosuppressive or other immunomodulatory therapy (such as prednisone ≥20 mg/ day, or its equivalent) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
11. Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period;
12. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
13. Received live attenuated vaccine within 14 days prior to enrollment;
14. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
15. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
16. Women who are breastfeeding;
17. Fertile women aged 18-59 years who plan to become pregnant or cannot use effective contraception or have egg donation plans from enrollment to 3 months after the study intervention;
18. Women who are pregnant (as judged by the participant's blood pregnancy test);
19. Had fever (axillary temperature> 37.0℃) before vaccination;
20. Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
21. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Sites

- Jiangsu Provincial Center for Disease Control and PreventionNanjing, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06474377)

## Related records

### Drugs (1)

- [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.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

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