A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

February 5, 2013 updated by: Sanofi

Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Dengue Vaccine Group
Participants will receive CYD Dengue vaccine as Visits 1 and 2.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
0.5 mL, Subcutaneous
Other Names:
  • CYD Dengue Vaccine
Active Comparator: Group 2: Control Group
Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2)
Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
Other Names:
  • OKAVAX®
  • AVAXIM® 80U
Experimental: Group 3: Co-administration Group
Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Other Names:
  • CYD Dengue Vaccine
  • TRIMOVAX®
Experimental: 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.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Other Names:
  • CYD Dengue Vaccine
  • NaCl 0.9% (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine.
Time Frame: 28 days after each Dengue vaccination and entire study duration
28 days after each Dengue vaccination and entire study duration

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination.
Time Frame: Day 28 after each Dengue vaccination
Day 28 after each Dengue vaccination
To provide information concerning the immunogenicity of childhood vaccines after primary vaccination.
Time Frame: Day 28 after post-vaccination
Day 28 after post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYD08
  • UTN: U1111-1111-5855 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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