Phase I Clinical Trial of a Candidate PCV13 in Healthy People

NCT ID: NCT05602480

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-31

Brief Summary

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.

This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1A

Subjects received one dose of PCV13 at 18 years of age and above.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

2A

Subjects received one dose of PCV13 at 6\~17 years of age.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

3A

Subjects received one dose of PCV13 at 2\~5 years of age.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

4A

Subjects received two doses of PCV13 at 12\~23 months of age.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

5A

Subjects received three doses of PCV13 at 7\~11 months of age.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

6A

Subjects received four doses of PCV13 at 3 months of age.

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

6B

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

6C

Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).

Group Type: ACTIVE_COMPARATOR

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

7A

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old).

Group Type: EXPERIMENTAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

7B

Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old).

Group Type: ACTIVE_COMPARATOR

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL, Intramuscular

Interventions

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL, Intramuscular

Intervention Type: BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

PCV13; Prevnar 13

Eligibility Criteria

Inclusion Criteria

• Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
• Subjects or guardians must provide informed consent forms with personal signature and date;
• Male and female of childbearing age should agree to take effective contraception measures;
• Subjects or guardians can obey the requirements of the clinical study;
• Axillary temperature below 37.3 °C.

Exclusion Criteria

• Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
• Received any pneumococcal vaccine;
• Allergic history to any drugs, vaccine or vaccine-related component;
• Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
• Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;
• Breast-feeding or pregnant women, or positive U-HCG;
• High blood pressure uncontrolled by medication;
• Known or suspected immune deficiency or immune suppression;
• Serious congenital malformation, history of organ resection or serious chronic illness;
• Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
• History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
• History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
• A vaccination-related contraindications that other investigator believes;
• Plans to participate in or is participating in any other clinical study;
• Any other factors judged by investigator that may interfere subject's compliance with the protocol.

• Minimum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Liaoning Chengda Biotechnology CO., LTD

INDUSTRY

Sponsor Role: collaborator

Wuhan BravoVax Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangtan Maternal and Child Health Hospital

Xiangtan, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Long Xu, Ph.D.

Role: CONTACT

ct@bravovax.com

+86 27 8798 8585 ext. 8251

Other Identifiers

CLI-09-I-2020001

Identifier Type: -

Identifier Source: org_study_id