Phase 2
N=4,002
Efficacy and Safety of Dengue Vaccine in Healthy Children
Dengue Virus · Dengue Fever · Dengue Hemorrhagic Fever · Dengue Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00842530 ↗Enrolled (actual)
4,002
Serious AEs
12.3%
Results posted
Jul 2019
Primary outcome: Primary: Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo — 45; 32 Cases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CYD Dengue Vaccine (Biological); Inactivated rabies virus vaccine (Biological); Placebo (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo |
45; 32 | — |
| SECONDARY Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo |
1; 2; 2; 2 | — |
| SECONDARY Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo |
14; 12; 61; 47 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo |
42.8; 26.6; 94.4; 27.7; 78.0; 30.5 | — |
| SECONDARY GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo |
107; 57.0; 235; 59.7; 193; 68.4 | — |
| SECONDARY GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo |
5.00; 5.00; 11.2; 5.24; 8.72; 5.31 | — |
| SECONDARY Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo |
57.7; 57.6; 0.1; 0.0; 28.6; 30.7 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo |
32.2; 34.3; 1.9; 4.0; 60.0; 59.3 | — |
Summary
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion.
Secondary objectives included to assess:
* Vaccine efficacy against severe VCD cases
* Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine
* Immune response to CYD dengue vaccine
* Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.
Other objectives included:
* Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine
* Vaccine efficacy against VCD cases due to each serotype
* Participants with clinical signs and symptoms for VCD
Eligibility Criteria
Inclusion Criteria
- Aged 4 to 11 years on the day of inclusion.
- Participant in good health, based on medical history and physical examination.
- Provision of assent form signed by the participants (for participants >= 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
- Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
- Participant attended one of the schools involved in the trial and living in the Ratchaburi Province.
- For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
Exclusion Criteria
- Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
- For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of blood or blood-derived products in the past 3 months.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.e
- Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
Data sourced from ClinicalTrials.gov (NCT00842530). 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.