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Showing 1-20 of 312 trials
NCT07054099
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
NCT07525245
This is an interventional study targeting parents of junior high school girls. The primary objective of the study is to evaluate the effectiveness of a vaccine chatbot in improving HPV vaccination rates among parents' junior high school girls. The secondary objectives are to evaluate the effectiveness in improving vaccine awareness and vaccination intention among parents. All participants will be enrolled and randomly assigned to four groups: (1) vaccine chatbot plus scientific videos, (2) vaccine chatbot only, (3) scientific videos only, and (4) a control group (no intervention). The chatbot will provide immediate, validated answers to participants' HPV vaccine-related questions. The scientific videos will cover content related to HPV vaccine safety, efficacy, and other relevant information. The study will compare changes in HPV vaccine awareness, vaccination intention, and vaccination behavior between the intervention groups and the control group after the intervention to evaluate whether the three intervention strategies enhance HPV vaccine awareness, vaccination intention, and vaccination uptake.
NCT04128189
The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection. The main questions it aims to answer are: How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant? Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose? How long does protection from the vaccine last before and after transplant? How safe is the vaccine in this group, including whether it affects transplant-related immune markers? Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection. Participants will: Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.
NCT06639386
Achieving optimal vaccination rates is vital for protecting the health and well-being of all individuals. This specific study focuses on the MMR and RSV vaccines in pregnancy and early childhood, which have been shown to reduce RSV and MMR-related illnesses, hospitalizations, and deaths. Efforts to improve vaccination rates have not been equally effective across the entire population; this has resulted in poorer outcomes from interventions for certain populations who are vaccine-hesitant. This study seeks to understand how to best increase vaccine confidence in marginalized populations. To do this, the investigators will interview parents of children who receive care at Boston Medical Center (BMC), Community Health Workers and other Clinical providers at BMC, leading experts in the fields of vaccine confidence and implementation science, and key public health stakeholders/officials.
NCT07505823
The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine following the primary series? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide durable immune persistence up to 18 months of age? What is the immunogenicity of a booster dose administered at 18 months of age? Researchers will compare the investigational vaccine group with the active comparator group (licensed group ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO) during the primary immunization phase. Only the investigational group will receive a booster dose at 18 months of age to evaluate booster immunogenicity and safety. Participants will: Be randomly assigned in a 1:1 ratio to receive either two doses of the investigational vaccine or two doses of the control vaccine according to a 0,1-month schedule during the primary immunization phase; In the investigational group only, receive a booster dose at 18 months of age; Provide blood samples at three time points: before primary vaccination, 30 days after primary vaccination, and at 18 months of age to assess primary immunogenicity and immune persistence; In the investigational group only, provide an additional blood sample 30 days after the booster dose to assess booster immunogenicity; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 1040 participants will be enrolled.
NCT07505836
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
NCT07365826
This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
NCT06703203
The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.
NCT04579588
The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
NCT06505993
The purpose of this community-engaged study is to test the ability of county-level strategies to increase uptake of COVID-19 vaccination. In this study the key objective is to test whether health communication strategies or health communication + county-specific structural/environmental support increases COVID-19 vaccine uptake and changes perceptions and beliefs about the vaccination at the county-level.
NCT07421037
The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.
NCT07421050
The objective of this study was to evaluate the safety of subunit influenza vaccine (adjuvant) in people aged 65 years and older.
NCT07418229
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years
NCT07416461
The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.
NCT01644721
Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival. Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention. Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated. Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored. Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
NCT07381088
This study aims to evaluate the effect of a structured education program delivered in primary health care settings on parents of children aged 0-2 years. The education focuses on childhood vaccination and related health perceptions. Parents will receive education covering childhood vaccines, vaccine hesitancy, evaluation of vaccine-related information obtained from digital sources, eco-anxiety, and perceived vulnerability to diseases. The study examines whether this education influences parents' levels of vaccine hesitancy, digital vaccine literacy, eco-anxiety, and perceived vulnerability to diseases. The findings are expected to contribute to the development of effective educational interventions in primary health care services to support informed parental decision-making regarding childhood vaccination.
NCT07377656
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
NCT06065176
The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine. If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine. If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities. STUDY ACTIVITIES: * An online enrollment survey * An in-person enrollment visit * Weekly online surveys for 20 weeks * Weekly COVID-19 tests for 20 weeks * Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19. * Additional COVID-19 tests if you have COVID-19 symptoms or tested positive. * Online survey questions in the middle and at the end of the study
NCT06036134
COVID-19 vaccines are available to children over six months, and these vaccines are powerful tools against this catastrophic pandemic. However, Hispanic/Latino children have lower COVID-19 vaccination rates than White non-Hispanic children .Our team of health communication and public health experts proposes a community-based theory-driven intervention that utilizes culturally-grounded narratives from digital storytelling to reduce Hispanic parents' COVID-19 vaccine hesitancy and increase their children's vaccine uptake.
NCT06700447
Adolescent girls and young women (AGYW) between the ages of 15-29 years continue to bear the brunt of Human Immunodeficiency Virus (HIV) infections in South Africa despite progress recorded in prevention and treatment programmes. The ongoing susceptibility of young women to HIV infection and the sub-optimal uptake of prevention options such as Pre-Exposure Prophylaxis (PrEP) that are highly effective creates a need for an HIV vaccine to benefit populations at substantial risk of HIV infection. However, lessons from previous vaccine studies and the recent COVID-19 vaccine have highlighted significant barriers to vaccine uptake, such as widespread misinformation and vaccine hesitancy. These challenges threaten the successful implementation of a future HIV vaccine. Building on these insights, this study will utilise psychological inoculation theory to develop and evaluate HIV vaccine messages among adolescent girls and young women. Primary objective: To compare changes in intentions to receive HIV vaccine following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost. Secondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioural economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a two-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about the HIV vaccine in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.