Clinical trial NCT01254422: Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Official title: Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue fever
Dengue hemorrhagic fever
CYD dengue vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.

Primary Objectives:

* To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection.
* To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.

Detailed description: Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged 2 to 11 years on the day of inclusion
* Assent form was signed and dated by the participant (for participants ≥ 7 years) and informed consent form was signed and dated by the parent(s) or another legally accepted representative, and by an independent witness if the two parents or legally accepted representative were illiterate
* Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all trial procedures
* Participants in good health, based on medical history and physical examination
* For a female participant of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination

Exclusion Criteria:

* Known pregnancy, or a positive urine pregnancy test (for female participant of child-bearing potential only)
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion
* Participants who plan to move to another country/region within the 18 coming months
* Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.

Primary outcomes:
measure: Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
timeFrame: Day 0 up to Day 14 post-any and each vaccination
measure: Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
timeFrame: Day 0 up to Day 14 post-each vaccination
measure: Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
timeFrame: Day 0 up to Day 14 post-each vaccination
measure: Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
timeFrame: Pre-Injection 1 and Post-Injections 2 and 3
measure: GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
timeFrame: Pre-Injection 1 and Post- Injections 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Ipoh, Perak
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching, Sarawak
country: Malaysia
city: Negeri Sembilan
country: Malaysia
Study officials:
affiliation: Sanofi Pasteur Singapore
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hss AS, Koh MT, Tan KK, Chan LG, Zhou L, Bouckenooghe A, Crevat D, Hutagalung Y. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine. 2013 Dec 2;31(49):5814-21. doi: 10.1016/j.vaccine.2013.10.013. Epub 2013 Oct 14.