Submitted by: N/A Last Updated by: Michelle Timban Estera 2016-05-06 14:44:44 Export to PDF

Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

PHRR121114-000015

Protocol No. CYD14

Unspecified

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue cases

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2011-06-01 77 2017-11-01 0000-00-00

Ongoing

Institution Classification Region LTO #
Sanofi Pasteur Private Business NCR CDRR-NCR-S-8
Institution Amount Region
Sanofi Pasteur N/A NCR
Name E-Mail Phone Number Postal Address
Erah Jean Baria erahjean.baria@sanofipasteur.com +632 4799106 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name E-Mail Phone Number Postal Address
Thelma Laot thelma.laot@sanofipasteur.com +632 4799106 4F Feliza Bldg, 108 V.A Rufino St., Legaspi Village Makati City
Name Expertise Affiliation
Mary Noreen M. Cabalfin-Chua, MD Pediatric and Infectious Disease Philippines-AFRIMS Virology Research Unit (PAVRU), Cebu
Maria Rosario Z. Capeding, MD Pediatric and Infectious Disease Research Institute for Tropical Medicine
Project Location Institutional Ethics Review Board
Philippines-AFRIMS Virology Research Unit (PAVRU), Cebu N/A
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Prevention of symptomatic, virologically-confirmed dengue cases.

Information on the symptomatic virologically confirmed dengue cases occurring > 28 days after Dose 3 (during the active phase) in terms of (i) Acute febrile illness, and (ii) Virologically confirmed [ Time Frame: 28 Days post-vaccination 3 ] [ Designated as safety issue: No ]

• Information on the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period [ Time Frame: Day 0 up to 12 months post vaccination ] [ Designated as safety issue: No ] • Information on the efficacy of CYD dengue vaccine in preventing symptomatic dengue cases either virologically confirmed or probable based on serological criteria, due to any of the four serotypes after each dose. [ Time Frame: 28 Days after each vaccination ] [ Designated as safety issue: No ]

Completed

  • Indonesia
  • Malaysia
  • Philippines
  • Thailand
  • Vietnam

Clinical Trial

Unspecified

2011-01-03

Date Amendment Classification Reason
2015-08-13 Amendments related to the protocol
2014-01-22 Amendments related to the protocol
2011-11-11 Amendments related to the protocol

Inclusion Criteria: • Aged 2 to 14 years on the day of inclusion and resident of the site zone • Subject in good health, based on medical history and physical examination • Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) • Subject able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination). • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination • Planned participation in another clinical trial during the present trial period • Self-reported 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) • Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection • Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion • 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 any trial vaccination • Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures • Identified as a site employee 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, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.

Interventional

Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus and Biological: Placebo: NaCl 0.9%

Participants will be randomized to either receive 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months. A subset of participants from each country will also be evaluated for reactogenicity and immunogenicity to enable the generation of country-specific data on reactogenicity, immunogenicity, and baseline dengue and JE antibody levels.

Randomized

Double Blind

(Subject, Caregiver, Investigator, Outcomes Assessor)

Parallel

Prevention

Phase III

3499

Unspecified

NA

01 Jun 2011

Utilization Utilization Info
No records found.

Copyright © One Window Project 2018. All rights reserved.