A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
2 other identifiers
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
2.7 years
February 5, 2010
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
28 days after each Dengue vaccination and entire study duration
Secondary Outcomes (2)
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
Day 28 after post-vaccination
Study Arms (4)
Group 1: Dengue Vaccine Group
EXPERIMENTALParticipants will receive CYD Dengue vaccine as Visits 1 and 2.
Group 2: Control Group
ACTIVE COMPARATORParticipants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2)
Group 3: Co-administration Group
EXPERIMENTALParticipants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2.
Group 4: Sequential Administration Group
EXPERIMENTALParticipants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2.
Interventions
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Eligibility Criteria
You may qualify if:
- Toddler in good health based on medical history and medical examination
- 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
You may not qualify if:
- 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
- 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
- Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Unknown Facility
San Pablo, Philippines
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2010
First Posted
February 8, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02