Clinical trial NCT01064141: A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Official title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Toddlers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 210
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination.

Primary Objectives:

* To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines.

Secondary Objectives:

* To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

Detailed description: Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.

Eligibility criteria: Inclusion Criteria :

* Toddler in good health based on medical history and medical examination
* Toddler aged 12 to 15 months on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
* Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
* Participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures
* Completion of previous vaccination program according to the national immunization schedule, except for measles

Exclusion Criteria :

* Family members from the Investigator or from the staff involved in the trial
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* History of central nervous system disorder or disease, including seizures
* History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
* Previous vaccination against measles-mumps-rubella, hepatitis A or varicella
* Previous vaccination against flavivirus diseases
* Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
* Planned participation in another clinical trial during the present trial period
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
* Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
* Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening
* Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening

Temporary exclusions: vaccination postponed until the condition is resolved:

* Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
* Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit
* Any vaccination received in the 4 weeks preceding vaccination

Primary outcomes:
measure: To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
timeFrame: 28 days after each Dengue vaccination and entire study duration
Secondary outcomes:
measure: To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
timeFrame: Day 28 after each Dengue vaccination
measure: To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
timeFrame: Day 28 after post-vaccination
Other outcomes:
Locations:
city: San Pablo City
country: Philippines
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: