A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
NCT ID: NCT01064141
Last Updated: 2013-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2010-01-31
2012-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: Dengue Vaccine Group
Participants will receive CYD Dengue vaccine as Visits 1 and 2.
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
0.5 mL, Subcutaneous
Group 2: Control Group
Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2)
OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
Group 3: Co-administration Group
Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2.
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Group 4: Sequential Administration Group
Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2.
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Interventions
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Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
0.5 mL, Subcutaneous
OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
15 Months
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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San Pablo, , Philippines
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-5855
Identifier Type: OTHER
Identifier Source: secondary_id
CYD08
Identifier Type: -
Identifier Source: org_study_id
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