Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: SIIPL qHPV vaccine: SIIPL qHPV vaccine [Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16,
and 18]
Control Intervention1: Gardasil: Gardasil [Quadrivalent Human Papillomavirus (HP
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy ambulant male and female subjects aged 9-26 years. 2) Females with intact uterus and not pregnant. Subject who are married/sexually active must agree to use effective contraception through Month 7 of the study. 3) Subjects who have not yet had sexual intercourse must either agree to remain abstinent through the 7 month study period, or if they become sexually active during the vaccination phase of the study, to use effective contraception for the 7 month study period. 4) Subject’s willingness and ability to comply with the requirements of the protocol as judged by the investigator. 5) Subject willing to sign a written informed consent (for subjects 18 years and above). 6) Either of the parent is willing to sign written informed consent form and subject is willing to sign written assent form (for subject 7) Married females must agree to refrain from sexual activity for 48 hours prior to any scheduled visit that includes a cervical sample.
Exclusion criteria
Exclusion criteria: 1) Subject has a known history of prior vaccination with HPV vaccine. 2) Subject concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens. 3) Subject with a current diagnosis or prior history of genital warts or treatment of genital warts. 4) Female subject with current diagnosis or history of treatment for cervical pre-malignancies or malignancy. 5) Female subject attempting to be pregnant for the study period 7 month. 6) Married female subject has clinical evidence of gross purulent cervicitis 7) Male subject with a current diagnosis or prior history of penile or anal cancers. 8) Subject has a history of any allergic diseases or severe allergic reaction to any agent 9) Subject has had an acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination. 10) Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired Human Immunodeficiency Virus infection. 11) coagulation disorder that would contraindicate IM injections. 12) Subject has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives. 13) Subject has history of any cancer, organ transplant or any other immune system disease. 14) Subject has had chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study. 15) Subject has received any oral or injectable antibiotics and/or antiviral from five days before screening through to enrolment. 16) Subject has history of receiving a blood transfusion or other blood products in three months prior to screening. 17) Subject has history of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned during the course of 7 month study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT of antibodies to 4 HPV types 1.among girls aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 2.among boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 3.among women aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 4.among men aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil. Occurrence, intensity and relationship adverse events of SIIPL qHPV with GardasilTimepoint: at 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT of 4 HPV types 1.In girls aged 9-14 yrs receiving SIIPL qHPV and Gardasil 2.In boys aged 9-14 yrs receiving SIIPL qHPV and 9-14 yrs of girls of Gardasil 3.At 24,36 month - among girls and boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 4.At 24,36 month - among women and men aged 15-26 yrs receiving qHPV and women aged 15-26 yrs receiving Gardasil Persistent infections at 12, 24, 36 month in females 15-26 yr Percentage of seroconverters at 7 monthTimepoint: at 7,12,24,36 month | — |
Countries
India
Contacts
Public ContactDr Hitt Sharma
Serum Institute Of India Pvt. Ltd
Outcome results
None listed