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Human Papilloma Virus Infection Type 16Phase 4NCT05279248

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

A Phase 4 study testing HPV+MMR（0d），HPV（6m）, HPV（0d），HPV（6m），MMR（7m） and MMR（0d），HPV（1m），HPV（7m） in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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） Read more about this study

Who is it for?
Ages 13 to 14 years, women onlyHealthy volunteers can take part
What is being tested?
HPV+MMR（0d），HPV（6m）, HPV（0d），HPV（6m），MMR（7m） and MMR（0d），HPV（1m），HPV（7m）
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesChina
Study dates
25 Aug 2021to 20 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 14 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Yuecheng Center for Disease Control and Prevention

    Shaoxing, Zhejiang, 3306

  • Wuyi Center for Disease Control and Prevention

    Wuyi, Zhejiang, 3307

Other trials in China

About this study

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

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）

Read the 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.

Being tested
HPV+MMR（0d），HPV（6m）, HPV（0d），HPV（6m），MMR（7m）, MMR（0d），HPV（1m），HPV（7m）
Keywords
Immunogenicity, Safety, Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli), Measles Mumps and Rubella Combined Vaccine, Live
Medical subject headings
Measles, Rubella, Mumps, Escherichia coli Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV+MMR（0d），HPV（6m）Biological

    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.

  • HPV（0d），HPV（6m），MMR（7m）Biological

    Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine.

  • MMR（0d），HPV（1m），HPV（7m）Biological

    Administrated with MMR vaccine at first day. And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months).

Study groups in NCT05279248
Study groupRoleWhat they receive
Group AExperimentalParticipants 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.
Receives: Biological: HPV+MMR（0d），HPV（6m）
Group BActive comparatorParticipants 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.
Receives: Biological: HPV（0d），HPV（6m），MMR（7m）
Group CActive comparatorParticipants 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)
Receives: Biological: MMR（0d），HPV（1m），HPV（7m）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Specific neutralizing antibodies at 7 months after first dose

  2. 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

    Measured: 1 months after vaccination

  3. 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

    Measured: 1 months after vaccination

  4. 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

    Measured: 1 months after vaccination

Secondary outcomes (3)

  1. 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.

    Measured: During the 7-day (Day 0-6) period following each vaccination

  2. Adverse events/reactions occurred within 30 days after each vaccination

    To evaluate number of adverse events/reactions compared with non-simultane vaccination group.

    Measured: Within 30 days (Day 0-30) after any vaccination

  3. Serious adverse events occurred throughout the study

    safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group.

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start25 Aug 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion20 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279248
Sponsor's protocol ID
ZJCDC202102801
Status last verified
Mar 2022
First submitted
4 Mar 2022
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PubMed 41276263

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HPV+MMR（0d），HPV（6m）, HPV（0d），HPV（6m），MMR（7m） and MMR（0d），HPV（1m），HPV（7m） in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05279248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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