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Brief Title: Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
Official Title: Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
Study ID: NCT04953130
Brief Summary: Add-Vacc is an unblinded cluster-randomised trial (CRT) with two arms: (i) the national HPV vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male HPV vaccination given to a multi-year cohort of boys (intervention arm). The CRT will be conducted in 26 communities/clusters (13 per arm) in northern Tanzania. Boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent HPV vaccine (Gardasil®) that protects against HPV 6, 11, 16, and 18. Population genital HPV prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. Blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.
Detailed Description:
Minimum Age: 14 Years
Eligible Ages: CHILD, ADULT
Sex: MALE
Healthy Volunteers: Yes
Mwanza Intervention Trials Unit, Mwanza, , Tanzania