A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia

ConditionsVaccine Effectiveness HPV Vaccination Single Dose Immunogenicity Cervical Cancer Prevention Quadrivalent HPV Vaccine

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age9-20

SponsorInternational Agency for Research on Cancer

About this trial

The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Girl/woman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.

Participant willing to sign a written informed consent (for participants 18 years of age and above).

Parent (s) willing to provide written informed consent and participant is willing to sign written assent form for participation (for participants below 18 years of age at the time of eligibility assessment).

Participant or parent (s) willing to comply with all study requirements.

Disqualifiers

Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.

Participant has a known history of prior vaccination with any HPV vaccine.

Participant known to be HIV positive (no routine HIV testing will be performed unless clinically indicated)

Participant currently enrolled in any other clinical studies of investigational products.

Trial design

Design model

Parallel

Treatments tested in this trial

quadrivalent HPV vaccine
Biological/Vaccine
CERVAVAC-4 single dose vaccine
quadrivalent HPV vaccine
Biological/Vaccine
Gardasil-4 single dose

Treatment groups

1,266 Participants

are divided into 2 treatment groups

Group A: Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccineExperimental treatment 1 intervention

Group B: Girls/women and boys vaccinated with single dose Gardasil-4 vaccineActive comparator 1 intervention

Trial outcomes

Primary outcomes

Geometric mean Titre (GMT) of IgG antibodies against HPV 16 and 18 assessed from blood samples collected at 24 months and measured by M9ELISA on Meso-scale Discovery (MSD®) platform

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Agency for Research on Cancer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: