Clinical trial NCT03999996: Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Official title: A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dengue Fever
Keywords: Vaccine
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 365
Sex: ALL
Minimum age (years): 13
Maximum age (years): 63
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.

Detailed description: The vaccine tested in this study is Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV). This study will look at the long-term antibody persistence and safety of Takeda's TDV in healthy adolescents and adults and will assess the impact of a booster dose.

The study has enrolled 365 healthy participants. Participants who previously received TDV in two parent trials (DEN-304 \[NCT03423173\] and DEN-315 \[NCT03341637\]), will be invited to participate in this follow-up trial. Participants will be assessed for antibody persistence and safety from Baseline (Month 0) through Month 15 (for participants from parent trial DEN-304 \[US\]) or Month 42 (for participants from parent trial DEN-315 \[Mexico\]). At Month 15 (for participants from parent trial DEN-304 \[US\]) or at Month 42 (for participants from parent trial DEN-315 \[Mexico\]), eligible participants will be randomized in 1:1 ratio to one of two trial groups to receive TDV or placebo:

A. Group 1- TDV 0.5 mL subcutaneous (SC) injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico\]).

B. Group 2- Takeda's tetravalent dengue placebo (dummy SC injection - this is a liquid that looks like the study drug but has no active ingredient), 0.5 mL, subcutaneous injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico).

This multi-centre trial will be conducted in US and Mexico. The overall time to participate in this study is up to 21 months for parent trial DEN-304 (US) and up to 48 months for parent trial DEN-315 (Mexico). Participants from parent trial DEN-304 (US) and participants from parent trial DEN-315 (Mexico) will come for 5 visits to the clinic which includes a final visit (Visit 5) 6 months after the booster dose for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Male or female participants (irrespective of serostatus at baseline in the parent trials (DEN-304 \[(NCT03423173)\] and DEN-315 \[NCT03341637\]) who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from at least one blood draw post-vaccination.

Exclusion Criteria:

1. Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area within the 2 years prior to Visit 1 Day 1 (Month 0).
2. Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.

Booster Exclusion Criteria:

1. Participants for whom baseline serostatus is not defined in the parent trials (DEN-304 \[(NCT03423173)\] and DEN-315 \[NCT03341637\]).
2. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
3. Known or suspected impairment/alteration of immune function, including:

   1. 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 Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids is allowed.
   2. 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 Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
   3. Administration of immunoglobulins and/or any blood products within the 3 months prior to administration of the TDV booster or placebo at Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); consider whether applicable as an exclusion criterion or criterion for delay.
   4. Receipt of immunostimulants within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
   5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Month 42 for participants from parent trial DEN-315 (Mexico) / Month 15 for participants from parent trial DEN-304 (US).
   6. Known human immunodeficiency virus (HIV) infection or HIV-related disease.
   7. Hepatitis C virus infection.
   8. Genetic immunodeficiency.
4. Abnormalities of splenic or thymic function.
5. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
6. Participants with history of current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a prolonged period of habitation (≥1 year) in a dengue endemic area during trial conduct.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])
timeFrame: Month 0 (Day 1)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)
timeFrame: Month 12
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)
timeFrame: Month 42 (DEN-315)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1])
timeFrame: Month 0 [Day 1)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)
timeFrame: Month 12
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)
timeFrame: Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])
timeFrame: Month 0 (Day 1)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)
timeFrame: Month 12
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)
timeFrame: Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 [Month 0 (Day 1])
timeFrame: Month 0 (Day 1)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)
timeFrame: Month 12
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) ((DEN-315)
timeFrame: Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])
timeFrame: Month 0 (Day 1)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)
timeFrame: Month 12
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)
timeFrame: Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1])
timeFrame: Month 0 (Day 1)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)
timeFrame: Month 12
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Month 15 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)
timeFrame: Month 42 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-booster dose at Month 48 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-booster dose at Month 48 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-booster dose at Month 48 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-booster dose at Month 48 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304.)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials
timeFrame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials
timeFrame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)
timeFrame: Pre-booster dose at Month 15 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)
timeFrame: 1 month post-booster dose at Month 16 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)
timeFrame: Pre-booster dose at Month 42 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)
timeFrame: 1 month post-booster dose at Month 43 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-Booster dose at Month 48 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials
timeFrame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)
timeFrame: 6 months post-booster dose at Month 21 (DEN-304)
measure: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)
timeFrame: 6 months post-Booster dose at Month 48 (DEN-315)
Secondary outcomes:
measure: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose
timeFrame: Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Mont 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9
measure: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials Prior to the Booster Dose
timeFrame: Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Month 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9
measure: GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase
timeFrame: Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 6 vs post-booster M 1; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315)
measure: GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase
timeFrame: Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs post-booster M 1
measure: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination
timeFrame: Days 1 through 7 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
measure: Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity
timeFrame: Days 1 through 14 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
measure: Percentage of Participants With Any Unsolicited AEs in the Booster Phase
timeFrame: Days 1 through 28 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase
timeFrame: Month 15 post-booster dose through Month 21 (DEN-304); Month 42 post-booster dose through Month 48 (DEN-315)
measure: Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose
timeFrame: Month 0 through Month 15 (DEN-304) and Month 42 (DEN-315)
measure: Percentage of Participants With Any SAEs in the Booster Phase
timeFrame: Month 15 post-booster dose after vaccination through Month 21 (DEN-304); Month 42 post-booster dose after vaccination through Month 48 (DEN-315)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: AES - DRS - Optimal Research Alabama - Huntsville
state: Alabama
city: Peoria
country: United States
facility: AES - DRS - Optimal Research Illinois - Peoria
state: Illinois
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC - Newton - PPDS
state: Kansas
city: Rockville
country: United States
facility: Optima Research
state: Maryland
city: Richfield
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. Minneapolis
state: Minnesota
city: Saint Louis
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
state: Missouri
city: Papillion
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Omaha
state: Nebraska
city: West Jordan
country: United States
facility: Advanced Clinical Research/Velocity Clinical Research
state: Utah
city: Ciudad De Mexico
country: Mexico
facility: Instituto Nacional de Pediatria
city: Ciudad de Mexico
country: Mexico
facility: CAIMED Investigacion en Salud S.A de C.V.
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: