Phase 3
N=614
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
Dengue Fever
Bottom Line
View on ClinicalTrials.gov: NCT04313244 ↗Enrolled (actual)
614
Serious AEs
8.6%
Results posted
Feb 2024
Primary outcome: Primary: Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58 — 1633.693; 1790.986; 1342.745; 1325.192 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 9vHPV Vaccine (Biological); Dengue Tetravalent Vaccine (TDV) (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58 |
1633.693; 1790.986; 1342.745; 1325.192; 7777.694; 7822.564 | — |
| SECONDARY Percentage of Participants With Seropositivity for HPV Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 as Measured by Immunoglobulin G Binding Assay (IgGBA) |
100.0; 99.1; 100.0; 99.1; 100.0; 99.1 | — |
| SECONDARY GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes |
719.1; 1691.4; 555.4; 494.3 | — |
| SECONDARY Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes |
100.0; 99.6; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes |
0.4; 99.6 | — |
| SECONDARY Percentage of Participants With Solicited Local Adverse Events for 7 Days Following Vaccination by Severity |
54.1; 42.8; 9.5; 6.5; 0.7; 0 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 14 Days Following Vaccination by Severity |
20.0; 18.0; 3.0; 0.7; 0.3; 0 | — |
| SECONDARY Percentage of Participants With Any Unsolicited AEs for 28 Days Following Vaccination |
8.8; 2.6 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
10.1; 7.2 | — |
Summary
The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.
Eligibility Criteria
Inclusion Criteria
- Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
- Participants who can comply with trial procedures and are available for the duration of follow-up.
Exclusion Criteria
- Has an elevated oral temperature ≥38°C (≥100.4°F) within 3 days of the intended date of vaccination.
- Participants with contraindications, warnings and/or precautions to vaccination with Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) vaccine as specified within the prescribing information.
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease.
- Known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0).
- Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
- Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
- Human immunodeficiency virus (HIV) infection or HIV-related disease.
- Hepatitis B virus infection.
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- Abnormalities of splenic or thymic function.
- Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of trial vaccine administration.
- Who have used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis versus treatment) must be documented. Trial entry should be delayed to allow for a full 24 hours to have passed since last use of antipyretics and/or analgesic medications.
- Previous and planned vaccination (during the trial conduct), against any flavivirus (except Japanese encephalitis [JE]) including dengue, yellow fever (YF) viruses or tick-borne encephalitis.
- Previous and planned vaccination (during the trial conduct) against HPV.
- Previous participation in any clinical trial of a dengue or other flavivirus (eg, West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
- Has a current or previous infection with a flavivirus such as Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.
Data sourced from ClinicalTrials.gov (NCT04313244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.