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Immunization clinical trials

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NCT ID: NCT05794113 Completed - Immunization Clinical Trials

Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Methods Study Procedures A two-centred randomized control trial (RCT) was conducted to evaluate the use of safety reporting via a mobile app compared to safety reporting via web-based CANVAS notifications amongst individuals receiving the influenza vaccine from October 6 to November 29, 2020 during the seasonal influenza vaccine campaign in Ottawa and Vancouver, Canada. Individuals were recruited at the time of receiving their influenza vaccine. Eligibility criteria included the ability to speak English or French, having an active email address and telephone number, and being immunized with the seasonal influenza vaccine. Randomization After study enrollment, participants were randomized to receive the online safety survey either through the mobile app or emailed a link to the online survey using a four-block randomization design. Web-based notification arm All participants randomized to the web-based notification arm received the following web-based CANVAS notifications. Briefly, participants received an email notifying them of their registration in the study. Eight days following their influenza vaccine, participants received an email with the survey link asking them to complete their online influenza vaccine safety survey. Participants received a reminder email on day 11 if they did not complete their survey. Further details on CANVAS surveillance and description of the questionnaire can be found here. Mobile app arm Participants randomized to the mobile app arm, received an email asking them to download the app and activate their account. Users who did not activate their account after 48 hours received a reminder email. Participants who activated their accounts, could spontaneously report an adverse event through the app, and were also notified of the day 8 survey through the app. Eight days following their vaccination mobile app participants who activated their account received a push notification on their phone to complete their survey. A reminder push notice was sent out on day 11 to participants that had not yet competed the day 8 survey. On November 16, 2020 (mid-way through the recruitment period), additional email reminders in the mobile app arm were implemented on days 2, 4 and 6 to remind participants to register for the app. All participants received a day 8 email directing them to use their CANImmunize account to complete their influenza vaccine survey. Access to the survey link also was available in the email reminder.

NCT ID: NCT05672927 Recruiting - HPV Infection Clinical Trials

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

Start date: January 18, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

NCT ID: NCT05213000 Recruiting - Immunization Clinical Trials

Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the extent to which a single session of light to moderate intensity exercise performed within 30 minutes after receiving either the initial dose of COVID-19 mRNA vaccine may modify the immune response to vaccination, and identify potential underlying mechanisms using gene expression and metabolite analysis. A secondary goal is to establish whether psychosocial factors are associated with immune response to vaccination. Participants will be randomized to either a 90-minute light to moderate intensity exercise session or daily routine as usual (no exercise) after receiving their initial COVID-19 mRNA vaccine. If assigned to exercise, the exercise will begin within 30 minutes after receiving the vaccine and will consist of a brisk walk and/or jog supervised by study personnel. Blood will be collected from participants prior the initial dose, two weeks after the initial dose, one week after the second dose if the individual receive the two-dose vaccine regiment or one month after the initial dose if the individual receives a one-dose vaccine regimen, and three, six, and 12 months following the initial dose. . Side effects will be measured for three days post-vaccination. Antibody and cell-mediated immune response to the vaccine will be measured in blood samples. Gene expression profiles will be analyzed by single cell RNA sequencing. Serum metabolites will be assessed to align with immune measures. Participants will be asked to complete surveys to measure physical activity history, psychosocial stress, resilience, and depression. The hypotheses of this study are: 1) a single session of exercise which take place shortly after receiving either the initial dose or the booster dose of COVID-19 will increase antibody and T cell response to the vaccine and will be associated with differentially expressed genes and an altered metabolite profile, and 2) higher levels of reported stress, and lower levels of resilience will be associated with a reduced antibody and T cell response to the vaccine.

NCT ID: NCT04936776 Enrolling by invitation - Pediatric ALL Clinical Trials

Pediatric Vaccinations

Start date: February 9, 2021
Phase:
Study type: Observational

As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.

NCT ID: NCT04295694 Completed - Immunization Clinical Trials

Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study

Start date: August 2014
Phase:
Study type: Observational

Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. PCT is being increasingly recognized as an inflammatory marker suggestive of serious bacterial infection, and is being used in clinical practice in the workup for acute febrile illness. Based on an elevated PCT level, further testing may be done, antibiotics may be started, and the patient may get admitted to the hospital for observation before identifying the cause of the elevated PCT level. The investigators believe that immunizations can cause an increase in PCT levels in the absence of an acute infection. Thus, a finding of elevated procalcitonin in a recently immunized child may not have the same clinical implication as it does in other clinical scenarios. To investigate this, the investigators designed this pilot prospective study to compare PCT levels immediately before and forty-eight hours after the administration of routine infant immunizations. The investigators will enroll healthy infants presenting for their two, four, and six-month well child visits at FamilyCare - Children's Medicine Center and receiving routine immunizations as recommended by the Centers for Disease Control.

NCT ID: NCT04274153 Completed - Clinical trials for Human Papilloma Virus

HPV Vaccination Study in Postpartum Women

PPV
Start date: August 3, 2020
Phase: Phase 4
Study type: Interventional

The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.

NCT ID: NCT04222595 Completed - Immunization Clinical Trials

FluPRINT Study: Characterisation of the Immune and Transcriptional Response to LAIV

Start date: October 16, 2019
Phase: N/A
Study type: Interventional

In 2013 the UK government introduced the nasal flu spray vaccine (Fluenz Tetra®) for use in children from 24 months to less than 18 years of age. This is a licensed vaccine that is safe, effective and like the injectable vaccine, needs to be given yearly. There is evidence that the nasal spray flu vaccine can offer better protection for children than the injectable flu vaccine but it is not yet fully understood why this is so. When the immune system responds to an infection or a vaccine, specific 'immune response' genes are activated or 'switched on'. This process is called gene expression and different types of immune responses cause the activation of different genes.This study is looking at how specific parts of the immune system like B and T cells respond to the nasal spray vaccine and how and what genes are activated by the vaccine. B cells make antibodies, a part of our immune system that helps to protect against invaders such as viruses or bacteria. The next time our bodies are exposed to the same invader, our B cells make antibodies that can recognise and stop the invader going on to cause an infection. Our T cells can help B cells to make antibodies and also help to direct the body to attack the invader instead of causing harm to healthy cells.

NCT ID: NCT03943875 Active, not recruiting - Clinical trials for Human Papilloma Virus

GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose

Start date: June 17, 2019
Phase: Phase 4
Study type: Interventional

We are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.

NCT ID: NCT03796585 Completed - Immunization Clinical Trials

Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies

Start date: January 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to identify barriers to utilization of immunization registries within a pharmacy context and tailor the information into a novel immunization registry training program.

NCT ID: NCT03705455 Not yet recruiting - Immunization Clinical Trials

Immunization Schedule Alert Platform

ISAP
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.