- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279248
The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine
March 14, 2022 updated by: Zhejiang Provincial Center for Disease Control and Prevention
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
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)
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Shaoxing, Zhejiang, China, 3306
- Yuecheng Center for Disease Control and Prevention
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Wuyi, Zhejiang, China, 3307
- Wuyi Center for Disease Control and Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 14 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A
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.
|
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.
|
ACTIVE_COMPARATOR: Group B
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.
|
Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine.
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ACTIVE_COMPARATOR: Group C
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)
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Administrated with MMR vaccine at first day.
And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody)
Time Frame: Specific neutralizing antibodies at 7 months after first dose
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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
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Specific neutralizing antibodies at 7 months after first dose
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Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination
Time Frame: 1 months after vaccination
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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
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1 months after vaccination
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Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination
Time Frame: 1 months after vaccination
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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
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1 months after vaccination
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Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination
Time Frame: 1 months after vaccination
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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
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1 months after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Time Frame: During the 7-day (Day 0-6) period following each vaccination
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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.
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During the 7-day (Day 0-6) period following each vaccination
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Adverse events/reactions occurred within 30 days after each vaccination
Time Frame: Within 30 days (Day 0-30) after any vaccination
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To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
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Within 30 days (Day 0-30) after any vaccination
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Serious adverse events occurred throughout the study
Time Frame: Up to 7 months
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safety analysis.
To evaluate number of SAEs compared with the non-simultane vaccination group.
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Up to 7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 25, 2021
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
June 20, 2023
Study Registration Dates
First Submitted
March 4, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (ACTUAL)
March 15, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Stomatognathic Diseases
- Mouth Diseases
- DNA Virus Infections
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Tumor Virus Infections
- Neoplasms, Squamous Cell
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Infections
- Communicable Diseases
- Measles
- Virus Diseases
- Papillomavirus Infections
- Papilloma
- Rubella
- Mumps
Other Study ID Numbers
- ZJCDC202102801
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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