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

Primary Purpose

Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Measles

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HPV+MMR(0d),HPV(6m)
HPV(0d),HPV(6m),MMR(7m)
MMR(0d),HPV(1m),HPV(7m)
Sponsored by
Zhejiang Provincial Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus Infection Type 16 focused on measuring Immunogenicity, Safety, Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli), Measles Mumps and Rubella Combined Vaccine, Live

Eligibility Criteria

13 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Females aged between 13 and 14 years when they receive the first vaccination (13≤age<15);
  2. Participants aged 13-14 years whose legal guardian can provide identity certificate, or representative can provide authorization;
  3. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
  4. Participants aged 13-14 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
  5. Able to comply with the requests of the study;
  6. Axillary temperature not higher than 37.0°C; Nonpregnancy verified by a urine pregnancy test;

Exclusion Criteria:

  1. Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
  2. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
  3. Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
  4. Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
  5. Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
  6. Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;
  7. Concurrently participating another clinical trial;
  8. Participants who have received HPV vaccines;
  9. Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.;
  10. Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
  11. Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid;
  12. Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.;
  13. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician;
  14. Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years;
  15. Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years;
  16. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Sites / Locations

  • Yuecheng Center for Disease Control and Prevention
  • Wuyi Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Participants in this arm will be simultaneously administrated with one dose of HPV 16/18 bivalent vaccine and one dose of MMR vaccine. six month later, they are going to receive a second dose of HPV 16/18 bivalent vaccine.

Participants in this arm will be receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months) first. After finished HPV vaccination, they are going to receive MMR vaccine at the 7th month.

Participants in this arm will be receieve MMR vaccine first. One month later, they are going to receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months)

Outcomes

Primary Outcome Measures

Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody)
Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the second dose to determine whether group A is non-inferior to group B
Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination
Detect the level of anti-measles specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination
Detect the level of anti-rubella specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination
Detect the level of anti-mumps specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C

Secondary Outcome Measures

Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Serious adverse events occurred throughout the study
safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group.

Full Information

First Posted
March 4, 2022
Last Updated
March 14, 2022
Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05279248
Brief Title
The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Measles, Rubella, Mumps
Keywords
Immunogenicity, Safety, Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli), Measles Mumps and Rubella Combined Vaccine, Live

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants in this arm will be simultaneously administrated with one dose of HPV 16/18 bivalent vaccine and one dose of MMR vaccine. six month later, they are going to receive a second dose of HPV 16/18 bivalent vaccine.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Participants in this arm will be receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months) first. After finished HPV vaccination, they are going to receive MMR vaccine at the 7th month.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Participants in this arm will be receieve MMR vaccine first. One month later, they are going to receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months)
Intervention Type
Biological
Intervention Name(s)
HPV+MMR(0d),HPV(6m)
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
HPV(0d),HPV(6m),MMR(7m)
Intervention Description
Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine.
Intervention Type
Biological
Intervention Name(s)
MMR(0d),HPV(1m),HPV(7m)
Intervention Description
Administrated with MMR vaccine at first day. And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months).
Primary Outcome Measure Information:
Title
Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody)
Description
Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the second dose to determine whether group A is non-inferior to group B
Time Frame
Specific neutralizing antibodies at 7 months after first dose
Title
Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination
Description
Detect the level of anti-measles specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time Frame
1 months after vaccination
Title
Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination
Description
Detect the level of anti-rubella specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time Frame
1 months after vaccination
Title
Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination
Description
Detect the level of anti-mumps specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C
Time Frame
1 months after vaccination
Secondary Outcome Measure Information:
Title
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Description
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time Frame
During the 7-day (Day 0-6) period following each vaccination
Title
Adverse events/reactions occurred within 30 days after each vaccination
Description
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time Frame
Within 30 days (Day 0-30) after any vaccination
Title
Serious adverse events occurred throughout the study
Description
safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group.
Time Frame
Up to 7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females aged between 13 and 14 years when they receive the first vaccination (13≤age<15); Participants aged 13-14 years whose legal guardian can provide identity certificate, or representative can provide authorization; Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations; Participants aged 13-14 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent; Able to comply with the requests of the study; Axillary temperature not higher than 37.0°C; Nonpregnancy verified by a urine pregnancy test; Exclusion Criteria: Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months; Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period; Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray); Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period; Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment; Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days; Concurrently participating another clinical trial; Participants who have received HPV vaccines; Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.; Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain; Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid; Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.; Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician; Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years; Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years; According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
Facility Information:
Facility Name
Yuecheng Center for Disease Control and Prevention
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
3306
Country
China
Facility Name
Wuyi Center for Disease Control and Prevention
City
Wuyi
State/Province
Zhejiang
ZIP/Postal Code
3307
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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