NCT06817187

Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine

A Single Center, Randomized, Open Label, Controlled Clinical Study to Evaluate the Mutual Influence of Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,110 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 3 Months
• Healthy volunteers: Accepted

Summary

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population

Conditions

• Streptococcus Pneumoniae Infections

Interventions

Type	Name	Description
BIOLOGICAL	15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
BIOLOGICAL	15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
BIOLOGICAL	Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: China