Clinical trials

This is a multicenter, open-label, blank-controlled clinical trial to evaluate the impact of influenza vaccination and pneumococcal vaccination on disease progression and medical burden in COPD patients aged 45-80 years, as well as the safety and immunogenicity of vaccination. COPD patients aged 45-80 years are recruited. On the basis of informed consent and voluntary participation, influenza and pneumococcal vaccination are carried out. At each site, towns/subdistricts will be randomly assigned as clusters to one of four groups in a 2:2:2:1 ratio: influenza vaccine group, pneumonia vaccine group, combined vaccination group, and blank control group. Follow-up lasts 12 months from informed consent. For the immunogenicity subgroup, during the period from September 1, 2026 to October 31, 2026, the first 50 participants enrolled for influenza vaccination at each site (Dongtai City and Wujin District) are included in the influenza vaccine immunogenicity subgroup, and the first 50 participants enrolled for pneumococcal vaccination at each site are included in the pneumococcal vaccine immunogenicity subgroup, with the two subgroups serving as mutual controls. Blood samples (5ml each time) are collected before vaccination and at 1 month, 6 months, and 12 months after vaccination.

This is a multicenter retrospective cohort study to evaluate the long-term effectiveness of the live attenuated herpes zoster vaccine within 6 years after vaccination. We plan to select 24,740 participants who were non-herpes zoster cases in the modified Full Analysis Set for Efficacy (E-mFAS) from the Phase III Clinical Trial (NCT04334577) of the live attenuated herpes zoster vaccine manufactured by Changchun BCHT Biotechnology Co. conducted during 2020-2021. In the original Phase III Clinical Trial, the participants were randomly assigned to the vaccine group and the placebo group at a 1:1 ratio to receive one dose of the live attenuated herpes zoster vaccine (with varicella-zoster virus \>=4.3 lg PFU per 0.5 mL dose) or one dose of placebo (with no varicella-zoster virus component), respectively. This study uses a stage-based design. In Stage 1, participants originally assigned to the vaccine group and those originally assigned to the placebo group will be compared to assess the cumulative incidence of herpes zoster from the end of the original Phase III Clinical Trial in July 2021 to the marketing authorization of the vaccine in China in June 2023. In Stage 2, after marketing authorization of the vaccine in China in June 2023, a large proportion of the participants originally assigned to the placebo group received catch-up vaccination and thereby formed a catch-up vaccination group. These stage-specific groups will be compared to evaluate the relative waning of protection in participants who received catch-up vaccination compared with participants vaccinated in the original Phase III Clinical Trial. In addition, among participants originally assigned to the placebo group who received catch-up vaccination, the incidence of herpes zoster during the post-catch-up vaccination period will be compared with the incidence during their earlier placebo period before catch-up vaccination, in order to evaluate the relative risk of herpes zoster under vaccinated versus placebo exposure. For this study, telephone surveys will be conducted using a standardized questionnaire to collect data on herpes zoster occurrence from participants, with verbal informed consent obtained prior to the survey. Face-to-face interviews will also be conducted to verify reported herpes zoster cases. Moreover, their past medical history and lifestyle information will be collected.

This is a single-center, prospective, open-label, partially randomized, matched-controlled trial designed as a cohort study. The study plans to enroll 360 healthy female participants aged 18 to 45 years, divided into three groups: a three-dose sequential group, a two-dose sequential group, and a primary immunization group, with 120 participants in each group. All participants will be stratified by two age subgroups (18-26 years and 27-45 years) to ensure demographic balance across groups. As blinding is not feasible in this study, a prospective, open-label, partially randomized, controlled trial design is adopted. A combination of randomized and non-randomized (i.e., partially randomized) enrollment methods is used to balance study feasibility with intergroup comparability. Participants in the three-dose sequential group and the primary immunization group will receive one dose of the nine-valent HPV vaccine at months 0, 1, and 6, while those in the two-dose sequential group will receive the nine-valent HPV vaccine at months 0 and 6. Before the second and third doses, investigators must confirm that participants do not meet the criteria for early withdrawal or for postponement of the second and third doses. After each vaccination, a 30-minute safety observation will be conducted at the vaccination site to monitor for adverse events (AEs). Subsequently, the study visit procedures will be followed, including collection of solicited AEs within 7 days post-vaccination, unsolicited AEs within 30 days, and serious AEs (SAEs) throughout the study period. Participants will also complete other scheduled study visits, including safety observations and immunogenicity blood sampling at various time points before and after vaccination. The study aims to evaluate the immune response characteristics and safety of sequential vaccination with different doses of the nine-valent HPV vaccine (three doses at 0, 1, 6 months and two doses at 0, 6 months) in healthy female participants who have previously completed vaccination with the bivalent HPV vaccine.

The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV/Hib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.