An RCT comparing antibody responses to single dose of Cervavac® and Gardasil® vaccines in healthy girls aged 9 to 14 years

Phase 2

• Registration Number: CTRI/2024/08/072040
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.