Chickenpox (Varicella)
Explore ongoing varicella research studies. Find chickenpox trials following HIPAA and IRB compliance standards.
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Found 17 Actively Recruiting clinical trials
RECRUITING
Healthy Volunteer
In this study: 1. The participation is voluntary. 2. Before the trial, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this trial. 3. The trial vaccine is LZ901 (100μg/0.5 mL). The placebo, which is aluminum hydroxide adjuvant, has no active drug. Participants will receive one of two as above mentioned. 4. This trial included a protective efficacy test and a batch-to-batch consistency test (immunization subgroup). Approximately 26000 subjects aged 40 years and older will be enrolled. Subjects will be randomized to receive either LZ901 or placebo in which about 3000 subjects will be enrolled into immunization subgroup and randomly receive three different batches LZ901 and one batch placebo at a ratio of 1:1:1:3. The immunization subgroup was designed to evaluate the batch-batch immunogenicity consistency among three different batches of LZ901, as well as the immunogenicity and immunogenicity persistence of the LZ901 at 12, 24, and 36 months after full immunization. 5. All subjects will receive the LZ901 or Placebo on day 0 and day 29. Subject will have 16 visits, including 5 on-site visits and 11 in-person visits except for subjects in the immunization subgroup who have 24 visits, including 8 on-site visits and 16 in-line visits. 6. The primary objective was to evaluate the Vaccine Efficacy (VE) of LZ901 against herpes zoster, as compared with placebo, after 30 days of full immunization in people 40 years of age and older. 7. The secondary objective was to evaluate the protective efficacy of LZ901, as compared with placebo, against laboratory-confirmed cases of HZ after 30 days of full vaccination in people 40 years of age and older. To evaluate the safety of LZ901. The immunogenicity of LZ901was evaluated (immunization subgroup). To evaluate the batch-to-batch consistency of immunogenicity of three batches of LZ901 in subject aged ≥40 years (immunization subgroup). 8. An exploratory objective was to evaluate the effect of LZ901 on reducing the severity of PHN in HZ subjects ≥40 years old." To evaluate the efficacy of LZ901 compared with placebo in preventing PHN in subjects ≥40 years old with HZ efficacy endpoint. The immunogenicity of LZ901 was evaluated at 12, 24 and 36 months after full immunization in subject ≥40 years old (immunization subgroup).
RECRUITING
Healthy Volunteer
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
RECRUITING
Healthy Volunteer
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
RECRUITING
Healthy Volunteer
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
RECRUITING
Healthy Volunteer
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.
RECRUITING
Healthy Volunteer
A sample of vaccine-naive (unvaccinated or under-vaccinated) adult community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region, will be recruited to participate in a human papillomavirus (HPV) multi-media intervention. Hypothesis: Vaccine-eligible adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccine uptake rates when compared to vaccine-eligible adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.
RECRUITING
Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples. Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions. Method: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples. These samples will be stored in a dedicated biological sampling department ("Platform of biological resources"). Conclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.
RECRUITING
Healthy Volunteer
1. Safety * Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration * Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration * Solicited local/systemic AEs occurred within 7 days after the IP administration * Unsolicited adverse events that occurred within 42 days after the IP administration * Serious adverse events that occurred within 1 year after the IP administration * Vital signs and physical examinations 2. Efficacy (Immunogenicity) -GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration 3. Exploratory assessment * GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration * GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years * Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
RECRUITING
Healthy Volunteer
Hepatitis A virus (HAV) infection remains a common cause of viral hepatitis among children and adolescents in developing countries, including Thailand. Currently, two types of HAV vaccines are available in Thailand; (1) inactivated HAV vaccine (I-HAV) which is recommended as a 2-dose series administered 6 months apart, approved for use in children aged 1 year and older, and (2) live-attenuated HAV vaccine (L-HAV) which is recommended as a single dose, approved for children aged 18 months and older. However, as neither vaccine is included in Thailand's Expanded Programme on Immunization (EPI), the national vaccination coverage remains suboptimal. In 2024, the investigators conducted a randomized, active-controlled, open-label, non-inferiority trial to compare the immunogenicity and safety of the currently marketed I-HAV and L-HAV in healthy Thai children and adolescents aged 18 months to 18 years. Preliminary results showed that a proportion of participants remained seronegative following a single dose of L-HAV (anti-HAV IgG \<1 S/CO). Based on these findings, the investigators hypothesize that an additional dose of I-HAV may be necessary to achieve adequate seroprotection in this population. Therefore, the aim of this study is to evaluate the immunogenicity and safety of an additional dose of I-HAV in healthy Thai children and adolescents who did not develop protective antibody levels after a single dose of L-HAV.
RECRUITING
Healthy Volunteer
OBJECTIVES The investigators aim to study the effects of providing measles vaccine (MV) or Bacille Calmette-Guérin vaccine (BCG) to women of fertile age, prior to pregnancy, and to study the added effect of providing MV earlier to their children, for measles-specific and non-specific immunity in the child and for overall health in mother and child. Specific objectives To study the interaction of maternal MV and BCG and early infant MV with respect to: * the magnitude of the measles-specific antibody response in women and children * the proportion of children with maternal measles antibodies at the time of measles immunization * the viral load following YF vaccination in children * overall health in women and children HYPOTHESES * Providing MV to women in the fertile age will increase the proportion of children, who are vaccinated in the presence of maternal measles antibody, both at 20 weeks and 9 months of age * Providing MV or BCG to women in the fertile age will reduce the child's viral load after a YF vaccine provided at 9 months of age * Providing MV or BCG to women in the fertile age will reduce maternal and child infectious disease morbidity by 20% METHODS The study will take place at the Bandim Health Project (BHP), Bissau, Guinea-Bissau. The investigators plan a 3-by-2 factorial trial with randomization of non-pregnant women of fertile age to MV, BCG or placebo, and randomization of their offspring (who will all get BCG at birth according to recommendations) to early MV or no early MV at 20 weeks of age. All children will get the recommended MV by 9 months of age. The study will enroll 2400 non-pregnant HIV-negative women, who will be randomized 1:1:1 to one of three injections: BCG, MV, or placebo (saline). The first 100 children born to mothers from each of the three groups and surviving until 20 weeks of age will be selected for follow-up. Within strata of maternal vaccination (BCG, MV, placebo) they will be randomized 1:1 to early MV at 20 weeks, or placebo (saline). Thus, a total of 6 groups (A-F) will be formed. By 9 months of age, 20 children in each randomization group will receive a yellow fever (YF) vaccine and then MV 5 days later. All other children will receive an MV and a YF vaccine when they reach 9 months of age. Setting: BHP's Health and Demographic Surveillance System (HDSS) covers six districts in the capital of Guinea-Bissau with around 100,000 individuals. The BHP follows all women of fertile age with monthly visits to register new pregnancies. All children are followed with 4-monthly home visits for infections, hospitalizations, and vaccinations. All vaccinations administered at the three health centers in the study area are documented by BHP. Furthermore, BHP monitors all consultations and admissions at the health centers and all pediatric consultations and admissions at the national hospital. Enrolment and randomization of women: Eligible women will be identified through the BHP HDSS. They will receive a home visit by a project assistant, who will explain the study. If they are interested in participating, they will be asked to come to a nearby health center. Here, following informed oral and written consent, a blood sample will be drawn and tested for HIV. If the HIV-test is positive, immediate counseling will be given by a trained project nurse and the woman will be referred to the HIV clinic, per current standard of care. A urine pregnancy test will be carried out. Provided negative HIV and pregnancy tests, an interview regarding background factors, including previous vaccinations, will be carried out. Finally, the woman will be randomized and treated according to the allocation. Follow-up for pregnancies and morbidity: Women will be followed for pregnancy. All participating women will also be followed with respect to morbidity (consultations, hospitalizations) at 2-monthly interviews and continuous documentation of hospitalizations and consultations. Maternal blood samples: All blood will be collected into Na-Heparin tubes. Baseline blood sample: All women enrolled will have a blood sample obtained by venipuncture at baseline, in conjunction with the HIV screening, just before randomization. Baseline+4weeks blood sample: A blood sample will be obtained after 4 weeks from 30 women from each group. These samples with be paired with the baseline sample to assess measles-specific antibodies level. Children: All children will be followed closely through monthly home visits, during which the mother will be encouraged to bring her child for the scheduled vaccines. At 20 weeks of age, the children will be invited for further randomization. Inclusion criteria: The first 100 children surviving until 20 weeks of age from each group of enrolled mothers, and having received all recommended vaccines, the 3rd pentavalent vaccine at least 6 weeks before, are eligible for further study randomization. Exclusion criteria: Exclusion criteria are lack of receipt of all scheduled vaccines, pentavalent vaccine less than 6 weeks ago (in which case children are asked to come back once 6 weeks are reached), and overt illness (in which case they will be referred for treatment and invited to come back when the child is well again). Randomization of children: Eligible children are identified at the monthly home visits and asked to come to a nearby health center in the afternoon. Here, provided maternal consent, they will be randomly allocated to early MV or placebo (saline). Child blood samples: All blood will be collected into Na-Heparin tubes. Measles specific arm: N=30 from each of Groups A-F: A 2 ml blood sample will be obtained at baseline (either 20 weeks of age or 9 months of age) and a second sample of 2 ml will be obtained at either 9 months of age (those bled first at 20 weeks of age) or 18 weeks after 9-month-vaccination (those bled first at 9 months of age) for assessment of measles-specific antibodies levels. Non-specific effect arm: N=20 from each of Groups A-F: Children will receive YF vaccine at 9 months of age, a blood sample will be obtained just before and a second sample will be obtained 5 days later for assessment of YF viraemia. Follow up for child morbidity and mortality: The 300 children enrolled in the child-vaccination part of the study as well as other children born to the 2400 women enrolled in the maternal vaccination study will be followed for morbidity and mortality. The data collection with be based on the HDSS regular home visits, the registration of consultations in the study area, and the registration of admissions to the pediatric ward of the national hospital. Vaccination and blinding: Women vaccination: Women will be vaccinated in right upper arm. The vaccine administrator will know what is given, but the women will not be told before the trial has come to an end. Child vaccination: MV and YF vaccine will be given subcutaneously according to the national recommendations. Placebo for MV at 20 weeks will be saline, provided subcutaneously in the same volume as MV. Analysis of blood samples: The blood samples will be analyzed in collaboration with our international colleagues. Measles antibodies: Total and measles-specific immunoglobulin G (IgG) levels will be analyzed. YF vaccine response: Children will receive a single dose of YF vaccine. A blood sample will be obtained 5 days after and tested for yellow fever viral load. Statistical analysis and sample size: Maternal and child morbidity data will be analyzed in standard survival analysis for time-to-event data to compare potential differential effects by vaccination allocation. The analysis will take into account other possible interventions or events, campaigns or epidemics, occurring during the period of follow-up. The study sample size of 2400 women is based on the anticipated delivery rates in the area. Based on census data from BHP, the annual incidence of new deliveries in women with one child of 12 months will be around 15%. Hence, with a cohort of 2,400 enrolled women, it is expected to register \>300 deliveries in the 5th -10th trimester after enrolment starts.
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