The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue. The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to receive: * TDV 0.5 mL subcutaneous injection * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses (8 subjects discontinued the trial before receiving the second dose). This multi-center trial was conducted in Mexico. The overall time to participate in this study was 270 days. Participants had multiple visits to the clinic including a final visit at Day 270.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
TDV subcutaneous injection
Normal Saline (0.9% NaCl) subcutaneous injection
Instituto Nacional de Pediatria (INP)
Mexico City, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico
Biodextra, S.A. de C.V.
Mexico City, Mexico
Mexico Centre for Clinical Research
Mexico City, Mexico
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.
Time frame: One month post second dose (Day 120)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.
Time frame: Six months post second dose (Day 270)
Seropositivity Rates for Each of the 4 Dengue Serotypes
Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: One month and six months post second dose (Day 120 and Day 270)
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10.
Time frame: One month and six months post second dose (Day 120 and Day 270)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm) and swelling (edema/induration) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centro de Atencion E Investigacion Medica (CAIMED) Mexico DF
Mexico City, Mexico
Time frame: Within 7 days after each vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Time frame: Within 14 days after each vaccination
Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 28 days after each vaccination
Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study
MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.
Time frame: From first vaccination (Day 1) through end of study (Day 270)
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: From first vaccination (Day 1) through end of study (Day 270)