NCT05279248

The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine

Immunogenicity and Safety of Concomitant Inoculation of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia Coli) and Measles Mumps and Rubella Combined Vaccine, Live

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention · Other Government
• Sex: Female
• Age: 13 Years – 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli) （HPV）and Measles Mumps and Rubella Combined Vaccine, Live（MMR）

Detailed description

Main subjects: To evaluate the immunogenicity of HPV vaccine and MMR vaccine at the same time but at different sites as not inferior to vaccination of HPV vaccine or MMR vaccine alone. Secondary subjects: To evaluate the safety of simultaneous administration of HPV vaccine and MMR vaccine.

Conditions

• Human Papilloma Virus Infection Type 16
• Human Papilloma Virus Infection Type 18
• Measles
• Rubella
• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	HPV+MMR（0d），HPV（6m）	Simultaneously administrated with MMR vaccine and HPV 16/18 bivalent vaccine at first. And six months later, administrated with the second dose of HPV 16/18 bivalent vaccine.
BIOLOGICAL	HPV（0d），HPV（6m），MMR（7m）	Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine.
BIOLOGICAL	MMR（0d），HPV（1m），HPV（7m）	Administrated with MMR vaccine at first day. And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months).

Timeline

• Start date: 2021-08-25
• Primary completion: 2022-12-31
• Completion: 2023-06-20
• First posted: 2022-03-15
• Last updated: 2022-03-29

Locations

2 sites across 1 country: China