Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children

ConditionHuman Papillomavirus (HPV) Infection

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age9-15

SponsorPT Bio Farma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 9-15 years;

Healthy;

Subject/parent or LAR appropriately informed and consent/assent signed;

Willing to comply with investigator instructions and study schedule.

Disqualifiers

Concurrent/other trial;

Evolving illness/fever ≥37.5°C;

Allergy to vaccine components;

Uncontrolled coagulopathy/blood disorder contraindicating IM injection;

Trial design

Design model

Parallel

Treatments tested in this trial

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Biological/Vaccine
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.
Tetanus-Diphtheria booster
Biological/Vaccine
A single 0.5 mL dose of Adsorbed Td (Tetanus-Diphtheria Toxoid) Vaccine Bio Farma containing purified tetanus toxoid and purified diphtheria toxoid.

Treatment groups

266 Participants

are divided into 2 treatment groups

Group A: 4vHPV + Td vaccineExperimental treatment 2 interventions

Group B: 4vHPV aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number and percentage of subjects seroconverted for anti-HPV types 6, 11, 16, and 18

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.

Time frame

28 days after vaccination

Sponsors and contacts

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

PT Bio Farma

Lead sponsor

Source ClinicalTrials.gov

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