None listed
Conditions
Interventions
Intervention1: One dose of CERVAVAC® [non-infectious, recombinant, quadrivalent HPV vaccine for type 6, 11, 16, and 18] manufactured by Serum Institute of India Pvt. Ltd. Pune.
We are giving one dose
which self-assemble into VLPs.
Each 0.5 ml dose contains approximately
L1 proteins for HPV 6 (20 mcg), HPV 11 (40 mcg), HPV 16 (40 mcg) and HPV18 (20 mcg)
Amorphous aluminum hydroxy-phosphate sulfate
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy girl volunteers aged 9-14 years, determined by clinical history and examination 2) Any one parent of the volunteer, is willing and able to sign the informed consent form 3) Volunteers willing to provide verbal assent and if 12 years and older are willing to sign the assent form 4) Volunteers and parent/s are willing and able to comply with the requirements of the protocol, as judged by the investigator
Exclusion criteria
Exclusion criteria: 1) Known history of prior vaccination with any HPV vaccine 2) History of allergic reactions to any vaccines or vaccine components 3) An acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination or receipt of any oral or injectable antibiotics and/or antivirals seven days before screening (Temporary exclusion; participant can be rescreened after 7 days of convalescence period) 4) History of coagulation disorder that is a contraindication for intramuscular injections. 5) History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological abnormality, mental or physical disability, blood dyscrasia, cancer, organ transplant, immune disorder, HIV infection or any condition which in the opinion of the investigator might interfere with the evaluation of the study 6) Administration 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. 7) History of transfusion of blood or blood products in the previous 3 months 8) History of or plan for administration of any non-study vaccine pre or post 30 days of administration of the study vaccine (Temporary exclusion; participant can be rescreened after 30 days of administration of any non-study vaccine) 9) Girl with menarche having her last menstrual period (LMP) more than 2 weeks from screening or inability to recall LMP (Temporary exclusion; participant can be rescreened within two weeks after the next menses) 10) Any health condition as determined by medical history and / or physical examination/ or lab investigations at the time of screening, which in the judgment of the ‘Investigator’ might compromise the participant’s health and safety 11) Any other condition/situation as determined at screening, which, in the judgment of the ‘ Investigator’ might compromise the participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The non-inferiority hypothesis will be tested at 24-months i.e. after completion of follow-up in the study. In both the vaccine arms, mean GMT and 95% confidence interval will be calculated. The GMT ratio (GMTR) defined as GMT of Cervavac® to GMT of Gardasil® will be calculated and the lower bound will be compared with 0.67 (lower bound of the WHO standard limit recommended for GMTR) using two-sided 95% CI for GMTR.Timepoint: Though the time points when GMT will be done are at baseline, 1 month, 12 months and 24 months post vaccination. The non-inferiority hypothesis will be tested at 24-months for primary objective while other timepoints are for secondary objectives. | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs with severity of grade 3 and above, with respect to causality and frequency among all the participants throughout the study durationTimepoint: throughout the study duration;Frequency of participants showing anti-HPV L1 antibody titres greater than or equal to the lower limit of detection among those who were seronegative at baselineTimepoint: endpoints will be assessed at baseline and 1, 12 and 24 months for HPV types 6, 11, 16 and 18 post-vaccination;GMTs of anti-HPV L1 binding antibodies against HPV types 16 and 18Timepoint: endpoints will be assessed at 1 and 12 months post-vaccination;GMTs of anti-HPV L1 binding antibodies against HPV types 6 and 11Timepoint: endpoints will be assessed at 1, 12 and 24 months post-vaccination;GMTs of neutralizing anti-HPV antibodies (using PBNA) against HPV types 16 and 18 in a randomly selected subset (30%)Timepoint: endpoints will be assessed at 1 and 24 months post-vaccination;SAEs post-vaccination throughout the study duration, with respect to causality, severity and frequency among all participants.Timepoint: throughout study duration;Solicited and unsolicited AEs among all the participants (including immediate AEs), for 30 days following vaccination, with respect to causality, severity and frequencyTimepoint: 30 days following IP administration | — |
Countries
India
Contacts
Public ContactDr Leyanna Susan George
ICMR-National Institute of Translational Virology and AIDS Research Formerly NARI
Outcome results
None listed