The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
Who can participate
Age range4 Years – 16 Years
SexALL
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Inclusion criteria
✓. Is aged 4 to 16 years, inclusive, at the time of randomization.
✓. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator.
✓. The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
✓. Can comply with trial procedures and are available for the duration of follow-up.
✓. Is included in the per-protocol set (PPS) of the trial.
✓. Was aged 4 to 11 years at the time of randomization in the study (Day 1 \[Month 0\]).
Exclusion criteria
✕. Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization.
✕. Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial.
✕. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
✕. Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
What they're measuring
1
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
Timeframe: 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination
✕. Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
✕. Is first degree relative of individuals involved in trial conduct.
✕. Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
✕. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination.