None listed
Conditions
Interventions
Intervention1: Quadrivalent HPV Vaccine (Gardasil, Merck): 2 doses, 0.5 ml i.m., 0 and 6 months
Control Intervention1: Quadrivalent HPV Vaccine (Gardasil, Merck): 3 doses, 0.5 ml i.m., at 0,2 and 6 mo
Sponsors
WHO
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion exclusion criteria:Healthy, ambulant, unmarried girls aged 10-18 years with intact uterus, residing in the selected villagesEligible girl as well as either or both the parents/legal guardian willing to sign a written informed consentExclusion criteria:·
Exclusion criteria
Exclusion criteria: Inclusion exclusion criteria:Healthy, ambulant, unmarried girls aged 10-18 years with intact uterus, residing in the selected villagesEligible girl as well as either or both the parents/legal guardian willing to sign a written informed consentExclusion criteria:· Participant having any allergies to medications, food, or any vaccine· Participant who has experienced a serious reaction after receiving any vaccination· Participant having any health problem with asthma, heart disease, lung disease, kidney disease, metabolic disease (e.g., diabetes), epilepsy or any neurological illness, mental or physical disability or blood dyscrasia· Participant who has/had cancer, leukemia, AIDS, or any other immune system problem· Participant who has taken cortisone, prednisone, other steroids, or anticancer drugs, or had radiation treatments in the past 3 months· Participant having any prior history of genital warts or treatment for genital warts· Participant who has received a blood transfusion, any blood products, or been given a medicine called immune (gamma) globulin in the past year· Participant has undergone any surgical procedure for the removal of the uterus· Participant married or engaged to be married in the next 6 months· Participant not willing to use any effective contraception through month 7 of the study if she gets married · Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled?.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generate scientific evidence on the efficacy of two-dose HPV vaccination regimen as compared to the current standard three-dose regimen; 2) Generate information on the feasibility, safety and acceptability of the two-dose HPV vaccination regimens; Timepoint: 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 3) Provide decision makers in India and other developing countries with operational, efficacy and safety data to empower them to make an appropriate, evidence-based HPV vaccination policy and to invest in its wide-scale implementation and disseminate the information on the lessons learned to inform India and other developing countries about the feasibility, effectiveness, safety and acceptability of the vaccination approaches. Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactNeerja Bhatla
All India Institute of Medical Sciences
Outcome results
None listed