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Vaccines

Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months.

Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months.

Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months.

Cecolin

Hecolin

Zhenggang Jiang

The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)

Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.

Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin

Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine

Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B

Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B

detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C

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.

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

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

Zhejiang Provincial Center for Disease Control and Prevention

Xiamen Innovax Biotech Co., Ltd

Mouth and Tooth Diseases

Measles

Rubella

Mumps

Escherichia coli Infections

Paramyxoviridae Infections

Mononegavirales Infections

Togaviridae Infections

Parotitis

Parotid Diseases

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

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)

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+MMR（0d），HPV（6m）

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

HPV（0d），HPV（6m），MMR（7m）

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

MMR（0d），HPV（1m），HPV（7m）

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）

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.

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

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

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

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

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

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

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.

Participants will use the Instructions for Use to perform self-collection of cervicovaginal cells using the Teal Health Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A Pap smear will be performed by a clinician before or after self-collection.

Teal Health Self-Collection Device Group

Evaluation of a novel self-collection device for cervical cancer screening.

The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Development of a Self-collection Device for Cervical Cancer Screening

Pilot Study: Evaluation of a Novel Self-Collection Device for Cervical Cancer Screening

Evaluate SAEs to confirm that SAEs from self-collection are equivalent to the rate of SAEs from health care provider-collection

Detection of high risk HPV in self-collected as compared to clinician-collected sample results.

Sample inadequacy rate defined as percent of high risk HPV DNA concentrations below the detection thresholds as determined by the manufacturer.

Usability Survey data will be analyzed to determine device design issues (There is no scale - questions are assessed individually)

Satisfaction and Needs Survey data will be used to assess subjects' general willingness to use an HPV self-collection device, and concerns about HPV self-collection. (There is no scale - questions are assessed individually)

Samples will be assessed to determine if there is an adequate number of cells for liquid-based cytology analysis

Teal Health, Inc.

Skin and Connective Tissue Diseases

Ear, Nose, and Throat Diseases

Warts

Condylomata Acuminata

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

The clinical team will be left to identify the need for a follow-up HPV vaccine through existing mechanisms

A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.

Simple Reminder

Gregory D Zimet, PhD

Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.

The study team plans to conduct a randomized clinical trial with three arms: (1) usual care, (2) the simple reminder, and (3) the simple reminder plus the script. Randomization will be carried out at the physician level at each clinical site, to ensure that all three treatment arms are represented in each clinic. The primary outcome, HPV vaccine acceptance, will be assessed for each study participant.

This study will be implemented through the Child Health Improvement through Computer Automation system (CHICA). CHICA is a computer based clinical decision support system that has been operating in the Wishard/Eskenazi system since 2004. CHICA now operates in 5 clinics in the health system and has served well over 37,000 children. CHICA supports primary pediatric care, supporting screening, counseling, anticipatory guidance, vaccinations, and chronic disease diagnosis and management.

CHICA is unique in several respects. These include a unique tailored, scannable paper interface, a prioritization scheme that assures the highest priority reminders are given to physicians, and the ability to collect data directly from families in the waiting room. CHICA acts as a front end to the Regenstrief Medical Record System (RMRS), the electronic medical record for the Eskenazi health system. The RMRS and CHICA communicate using industry standard HL7 communication protocols.

When a patient checks into a CHICA clinic, CHICA receives an HL7 ADT (registration) message. In response CHICA requests a download of the patient's record from the RMRS. CHICA applies a set of Arden Syntax rules to the patient's data to select 20 yes/no questions that are printed. The family answers these questions by checking boxes. The nurse or medical assistant enters height, weight, etc. on the same form and the form is scanned. The data enter CHICA's database through optical mark recognition and optical character recognition. Recently we have begun converting from this scannable paper format to electronic tablets.

HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3

Individual provider data will not be made available.

To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine.

The study team will compare changes in vaccination rates with qualitative feedback from providers.

Merck Sharp & Dohme LLC

Indiana University

Regenstrief Institute, Inc.

THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). Two programs have been developed. Parents/guardians of children who have not received the first HPV vaccine, will first assess whether the family has already decided in favor of the HPV vaccine or if they would like more information. The parent/guardian will be shown a video specific to where they are in the decision-making process. After completion, the THEO system will then ask the parent/guardian a series of Post Video questions. Parents/guardians of children who have received the first or second vaccine in the series, will emphasize the need to make the first vaccine "count". Pre and post video questions have been developed.

THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.

THEO

This primary goal of this study is to assess whether patient whose parents watch a standardized digital video using the integrated digital approach during a routine office visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to those not completing the program. The study team anticipates eligible patients in the intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses) than patients in the usual care comparison clinics.

Additionally, the study team is interested in determining the impact of the integrated system on clinical workflow by measuring the number of minutes of each patient office visit when using the system compared to the number of minutes of each visit in offices where the system is not used.

Although this is a descriptive/exploratory aim, our expectation is that the THEO system will have minimal impact on patient flow.

Brief Summary of Design: This is a 2-arm randomized study, with randomization occurring at the level of clinic. Five clinics will be included (2 implementing the THEO video; 3 providing usual care). All five clinics have been using the Child Health Improvement through Computer Automation System (CHICA) for several years. The evaluation phase of the study will last for approximately 6-7 months.

The CHICA System

The Child Health Improvement through Computer Automation system (CHICA) is a computer based decision support system that operates as a front end to the electronic medical record system (EMR). When a child is registered in the clinic, the registration system sends an HL7 ADT (registration) message to CHICA. In response, CHICA requests a download of the patient's record from the EMR. CHICA applies a rule base consisting of hundreds of Arden Syntax rules to the data in the record to select 20 yes/no questions that are displayed on an electronic tablet. The family answers the questions and returns the tablet to the medical assistant who enters the child's height, weight and other measurements onto another page on the tablet.

At the same time that CHICA produces the questions for family, it sends an HL7 request to CHIRP, the Indiana immunization registry. In response, CHICA receives a download of the child's immunization record. The download includes CHIRP's "forecast" of the immunizations for which the patient is due.

At the end of these processes, CHICA produces several paper documents. The first is the physician worksheet (PWS). The PWS includes up to six alerts and reminders for the physician. The reminders are selected by CHICA, using its Arden Syntax rule set based on the patient's EMR and answers provided on the tablet. Each alert has up to six check boxes with which the physician can document how s/he responded to the alert. The PWS, when completed, is scanned, the coded data corresponding to the check boxes are stored, and text is written into the physician's note in the medical record. CHICA may also produce any of a large number of handouts for helping the physician with assessment or patient education. CHICA also produces a summary of the patient's immunization history as well and advice on what shots the child is due to receive.

In an ongoing study of the Regenstrief-Merck collaboration, the investigators are studying the effect of providing physicians with a suggested "script" for recommending HPV vaccination to eligible patients' families. The study randomizes by physician whether the script is provided or whether the physician receives a simple reminder.

Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine

Individual provider data will not be shared.

Difference between average HPV vaccine series initiation and completion rates (as recorded in the CHIRP immunization registry) between sites using THEO integrated technology product compared to HPV Vaccination rates at Eskenazi sites not using THEO integrated technology product. Note that CHICA operates in 5 clinics in the Eskenazi Health Network. These clinics have been matched into two groups, each with 2 clinics, based on race and ethnicity of their patients. We will randomly assign one of these two groups to use THEO. The other group plus an additional CHICA clinic will continue to use CHICA without THEO.

Relative differences in overall time of appointment for patient visits in which any dose of the HPV vaccine was given after using the integrated digital intervention, compared to overall time of appointment for patient visits in which any dose of the HPV vaccine was given after not using the integrated digital intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin	NCT05415345	Human Papilloma... Human Papilloma... Hepatitis E Vir...	Cecolin Hecolin	18 Years - 25 Years	Xiamen Innovax Biotech Co., Ltd
The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine	NCT05279248	Human Papilloma... Human Papilloma... Measles Rubella Mumps	HPV+MMR（0d），HPV... HPV（0d），HPV（6m）... MMR（0d），HPV（1m）...	13 Years - 14 Years	Zhejiang Provincial Center for Disease Control and Prevention
Development of a Self-collection Device for Cervical Cancer Screening	NCT05669911	Human Papilloma... Human Papilloma... Human Papilloma...	Teal Health Sel...	25 Years - 65 Years	Teal Health, Inc.
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3	NCT02558803	Human Papilloma... Human Papilloma... Human Papilloma... Human Papilloma... Cervical Cancer Genital Warts Oropharyngeal C...	Simple Reminder	11 Years - 17 Years	Regenstrief Institute, Inc.
Development of a Self-collection Device for Cervical Cancer Screening	NCT05669911	Human Papilloma... Human Papilloma... Human Papilloma...	Teal Health Sel...	25 Years - 65 Years	Teal Health, Inc.
Use of a Patient Education/Messaging Platform to Increase Uptake and Series Completion of the HPV Vaccine	NCT02546752	Human Papilloma... Human Papilloma... Human Papilloma... Human Papilloma... Cervical Cancer	THEO	11 Years - 17 Years	Regenstrief Institute, Inc.
HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3	NCT02558803	Human Papilloma... Human Papilloma... Human Papilloma... Human Papilloma... Cervical Cancer Genital Warts Oropharyngeal C...	Simple Reminder	11 Years - 17 Years	Regenstrief Institute, Inc.
The Immunogenicity and Safety of the Vaccination of Human Papillomavirus Vaccine and Measles-Mumps-Rubella Vaccine	NCT05279248	Human Papilloma... Human Papilloma... Measles Rubella Mumps	HPV+MMR（0d），HPV... HPV（0d），HPV（6m）... MMR（0d），HPV（1m）...	13 Years - 14 Years	Zhejiang Provincial Center for Disease Control and Prevention

Spots Global Cancer Trial Database for human papilloma virus infection type 16