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Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT01436396
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE September 19, 2011
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
Information on the antibody to yellow fever virus post Stamaril vaccination [ Time Frame: 28 days post-vaccination ]
Yellow Fever antibodies will be determined by a yellow fever virus plaque reduction neutralization test (YF PRNT50) assay
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01436396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
  • Information concerning the immunogenicity of CYD dengue vaccine post vaccination [ Time Frame: 28 days post-CYD dengue vaccination ]
    Dengue antibodies will be determined by a dengue virus plaque reduction neutralization test (PRNT50) assay
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post-vaccination with yellow fever and CYD dengue vaccines [ Time Frame: Day 0 up to 6 months post-final vaccination ]
    Solicited injection site reactions: Tenderness, Erythema, and Swelling; Solicited Systemic Reactions: Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
Official Title  ICMJE Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru
Brief Summary

The study is designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.

Primary Objective:

  • To demonstrate the non-inferiority of the immune response against Yellow Fever in flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to subjects receiving one dose of Stamaril vaccine concomitantly with placebo.

Secondary Objectives:

  • To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of subjects at baseline.
  • To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.
  • To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.
Detailed Description All participants will receive a total of 8 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies will be performed in a randomized subset of participants. All participants will be followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue
  • Dengue Hemorrhagic Fever
  • Yellow Fever
Intervention  ICMJE
  • Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus
    0.5 mL, subcutaneous at age 12, 18, and 24 months
    Other Name: CYD Dengue Vaccine
  • Biological: Yellow fever vaccine
    0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
    Other Name: Stamaril®
  • Biological: Measles, mumps, and rubella vaccine
    0.5 mL, subcutaneous at age 12 to 13 months.
    Other Name: MMR vaccine
  • Biological: Pneumococcal Conjugated Vaccine
    0.5 mL, intramuscular at age 13 to 14 months
  • Biological: Hepatitis A Pediatric Vaccine
    0.5 mL, intramuscular at age 13 to 14 months
  • Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
    0.5 mL, intramuscular at age 19 to 20 months
    Other Name: DTaP IPV//Hib Vaccine
  • Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus
    0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months
    Other Name: CYD dengue vaccine
  • Biological: Yellow Fever Vaccine
    0.5 mL, subcutaneous at age 12 to 13 months
    Other Name: Stamaril®
  • Biological: Placebo (NaCl)
    0.5 mL, subcutaneous at age 12 to 13 months
    Other Name: NaCl 0.9%
  • Biological: Measles, mumps, and rubella vaccine
    0.5 mL, subcutaneous at age 13 to 14 months
    Other Name: MMR vaccine
Study Arms  ICMJE
  • Experimental: CYD Dengue Vaccine Group 1
    Participants will receive Stamaril® + CYD dengue vaccine dose 1 at age 12 to 13 months; measles, mumps, and rubella vaccine + pneumococcal conjugated vaccine + hepatitis A vaccine at 13 to 14 months; CYD dengue vaccine dose 2 at 18 to 19 months; DTaP IPV/Hib vaccine at 19 to 20 months; and CYD dengue vaccine dose 3 at 24 to 25 months.
    Interventions:
    • Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus
    • Biological: Yellow fever vaccine
    • Biological: Measles, mumps, and rubella vaccine
    • Biological: Pneumococcal Conjugated Vaccine
    • Biological: Hepatitis A Pediatric Vaccine
    • Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
  • Experimental: CYD Dengue Vaccine Group 2
    Participants will receive Stamaril + placebo at age 12 to 13 months; measles, mumps, and rubella vaccine + pneumococcal conjugate vaccine + hepatitis A vaccine at 13 to 14 months; CYD dengue vaccine dose 1 at 18 to 19 months; DTaP IPV/Hib vaccine at 19 to 20 months; and CYD dengue vaccine dose 2 at 24 to 25 months.
    Interventions:
    • Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus
    • Biological: Yellow Fever Vaccine
    • Biological: Placebo (NaCl)
    • Biological: Measles, mumps, and rubella vaccine
    • Biological: Pneumococcal Conjugated Vaccine
    • Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2011)
792
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 12 to 13 months on the day of inclusion.
  • Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg as reported by the parent/legally acceptable representative.
  • Subject in good health, based on medical history and physical examination.
  • Subject has completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively.
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations).
  • Subject and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Planned receipt of any vaccine in the 4 weeks following first trial vaccination.
  • Previous vaccination against yellow fever (YF), hepatitis A, or measles, mumps and rubella.
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative.
  • History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative.
  • Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative.
  • Known systemic hypersensitivity to any of the vaccine components of the vaccines that will be used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances.
  • History of contraindication to receipt of vaccines containing components of Stamaril (yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine, pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio or other DTP vaccine (e.g., DTwP).
  • Thrombocytopenia, as reported by the parent/legally acceptable representative.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular (IM) vaccination.
  • History of central nervous system disorder or disease, including seizures.
  • Personal history of thymic pathology (e.g., thymoma), and/or thymectomy.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Identified as a child (adopted or natural) of the Investigator or of employees 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 13 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01436396
Other Study ID Numbers  ICMJE CYD29
U1111-1116-4913 ( Other Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP