Dengue fever
Conditions
Interventions
Study sites
i. Colombo North Teaching Hospital
ii. Colombo South Teaching Hospital
iii. Lady Ridgeway Hospital for Children
iv. Negombo General Hospital
Method of randomization:
Randomization ra
Sponsors
Yanee Hutagalung, MD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Is aged 4 to 16 years, inclusive, at the time of randomization. 2. 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. 3. 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. 4. Can comply with trial procedures and are available for the duration of follow-up
Exclusion criteria
Exclusion criteria: 1. Has febrile illness (temperature >38°C) or moderate or severe acute illness or infection at the time of randomization. 2. 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. 3. 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). 4. 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. 5. Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine. 6. Is first degree relative of individuals involved in trial conduct. 7. 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). 8. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination. 9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily. 10. Current alcohol abuse or drug addiction that may interfere with the participant’s ability to comply with trial procedures. 11. Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype VE defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature >38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). [Time Frame: 30 days post-second vaccination (Day 120) until the end of Part 1 (120 cases of dengue fever are confirmed and minimum duration of subject follow-up of 12 months post-second vaccination)] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype 2. VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline 3. VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline 4. VE of Two Doses of TDV in Preventing Hospitalization due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype 5. VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype 6. Percentage of Participants with Solicited Local Injection Site Adverse Events (AEs) in the Safety Subset Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. 7. Severity of Solicited Local Injection Site Adverse Events (AEs) in the Safety Subset Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. 8. Percentage of Participants with Solicited Systemic Adverse Events (AEs) in the Safety Subset Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (? 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. 9. Severity of Solicited Systemic Adverse Events (AEs) in the Safety Subset Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (? 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. 10. | — |
Countries
Brazil,Colombia,Dominican Republic,Nicaragua,Panama,Philippines,Sri Lanka,Thailand,Viet Nam
Contacts
Public ContactDr. LakKumar Fernando
Consultant Paediatrician
Outcome results
None listed