Human Papillomavirus (HPV) Infection
Conditions
Brief summary
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. The study will compare participants who receive the HPV vaccine together with the Td vaccine with those who receive the HPV vaccine alone. The study will assess whether giving the two vaccines together produces an immune response to HPV that is not lower than giving the HPV vaccine alone.
Detailed description
This study is a randomized, open-label, two-arm, parallel-group, prospective interventional Phase III trial designed to evaluate the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine when administered concomitantly with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9 to 15 years. Participants will be assigned to receive the quadrivalent HPV vaccine together with the Td vaccine or the quadrivalent HPV vaccine alone. The study will assess antibody responses to the HPV vaccine antigens. Safety will be evaluated throughout the study by monitoring solicited and unsolicited adverse events, serious adverse events, and other clinically relevant safety findings. The study is intended to provide clinical evidence on the concomitant administration of the quadrivalent HPV vaccine with Td vaccine in the target pediatric population.
Interventions
A single 0.5 mL dose of quadrivalent recombinant human papillomavirus (HPV) vaccine targeting HPV types 6, 11, 16, and 18, administered by intramuscular injection.
BIOLOGICALTetanus-Diphtheria booster
A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 9-15 years; 2. Healthy; 3. Subject/parent or LAR appropriately informed and consent/assent signed; 4. Willing to comply with investigator instructions and study schedule.
Exclusion criteria
1. Concurrent/other trial; 2. Evolving illness/fever ≥37.5°C; 3. Allergy to vaccine components; 4. Uncontrolled coagulopathy/blood disorder contraindicating IM injection; 5. Recent treatment likely to alter immune response; 6. Pregnancy/breastfeeding; 7\. Abnormality/chronic disease interfering with objectives; 8. History of HPV/diphtheria/tetanus infection; 9. Previous HPV vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18 | 28 days after vaccination | Number and percentage of subjects who seroconvert for anti-HPV types 6, 11, 16, and 18. Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined lower limit of quantification (LLOQ) in the serum of subjects who are seronegative before vaccination, as measured by enzyme-linked immunosorbent assay (ELISA). The seroconversion rate in the group receiving 4vHPV vaccine co-administered with Td vaccine will be compared with that in the group receiving 4vHPV vaccine alone to evaluate non-inferiority. |
Countries
Indonesia
Contacts
CONTACTRini Mulia Sari, MD
CONTACTMita Puspita, MD
PRINCIPAL_INVESTIGATORDominicus Husada, Professor
Dr. Soetomo General Hospital
Outcome results
None listed