Treatment Trials

16 Clinical Trials for Various Conditions

Focus your search

RECRUITING
An Adaptive Prenatal Intervention to Increase Childhood Vaccinations
Description

This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.

COMPLETED
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
Description

The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.

Conditions
COMPLETED
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
Description

In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).

COMPLETED
Text Message Reminder-Recalls For Early Childhood Vaccination
Description

Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.

Conditions
COMPLETED
Tailoring of Vaccine-Focused Messages: Moral Foundations
Description

This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.

COMPLETED
Age-Specific Strategies for Immunization Reminders and Recalls
Description

The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.

COMPLETED
Vaccine Hesitancy Intervention--Provider (VHIP)
Description

The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.

COMPLETED
Tailoring of Vaccine-Focused Messages: Disease Salience
Description

This study is the second phase of a trial examining decision making about vaccines. For this phase of this study, the researchers will conduct a 3-arm randomized trial to compare the current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message, a new cervical cancer focused message developed by the study team, and a non-vaccine related control passage among parents of adolescent females. The goal of the trial will be to determine if the new cervical cancer framed message has an increased impact on intent to have daughters receive the HPV vaccine over the trial period as compared to the current CDC message used in the field. Additionally, the researchers will examine the impact both the CDC message and the new message individually have on intent to vaccinate when compared to the non-vaccine related control message. The participant's vaccine beliefs and intent to vaccinate will be assessed through an online survey at baseline. Two weeks later, participants will be randomized to view one of the three messages: the current CDC message, the cervical cancer framed message, or a non-vaccine related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will be assessed to determine the impact of the message.

COMPLETED
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado
Description

This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission. Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) on improving influenza vaccination rates. The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

COMPLETED
From Innovation to Solutions: Childhood Influenza Vaccination Planning
Description

The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.

Conditions
COMPLETED
Evaluation of the School Kids Influenza Prevention Project
Description

Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.

COMPLETED
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
Description

Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)

COMPLETED
Human Papillomavirus (HPV) Vaccination Among Survivors of Childhood Cancer
Description

This study will focus on the primary objectives: * To estimate the prevalence of HPV vaccination among a large cohort of childhood cancer survivors and an acquaintance control group. * To describe the difference in HPV vaccination rate and HPV vaccination intent among preadolescent/adolescent females surviving childhood cancer and an acquaintance control group. This study will also focus on the secondary objectives: * To examine sociodemographic, medical, and psychological differences between those who have/have not initiated HPV vaccination and between those who do/do not intend to get vaccinated in the future. * To assess the general predictive influence of sociodemographic, medical, and psychological variables on HPV vaccination and intent among mothers with preadolescent/adolescent daughters.

RECRUITING
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
Description

This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).

COMPLETED
Development of Childhood Anti-Influenza Immunity
Description

This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.

COMPLETED
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Description

A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North Carolina, and Cincinnati Children's Hospital Medical Center. Eligible infants will be randomized 1:1 to receive either 2-month US licensed childhood vaccines (PCV13, DTaP, HBV, IPV an Hib) or no vaccines. After their participation in the study, healthcare providers of the infants in the unvaccinated group will make decision abut receipt of their 2-month childhood vaccines. The study will collect data from the continuous cardiorespiratory and pulse oximetry monitors from randomization to 48 hours after randomization for infants in the unvaccinated group, and from randomization to 48 hours after vaccination for infants in the vaccinated group. Infants in both groups will be monitored for up to 60 hours for the occurrence of apnea, bradycardia, and oxygen desaturation. For infants in the "vaccinated" group, the study will also collect adverse events of clinical interest and serious adverse events occurring between the end of the 48-hour monitoring period and 14 days after vaccination. This information will be collected through parental report and review of medical records.