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Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00875524
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

This trial evaluated the use of a tetravalent vaccine against dengue.

Primary objectives:

  • To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
  • To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
  • To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Condition or disease Intervention/treatment Phase
Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Disease Biological: CYD dengue vaccine serotypes (1, 2, 3, 4). Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide Phase 2

Detailed Description:
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind- observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor participant had access.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
Actual Study Start Date : March 2009
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: CYD Dengue Vaccine Group
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).
0.5 mL, Subcutaneous
Other Name: ChimeriVax™

Sham Comparator: Control Vaccine Group
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Each at 0.5 mL, Subcutaneous, respectively
Other Names:
  • Meningococcal Polysaccharide Vaccine A+C
  • NaCl
  • Typhim Vi®




Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine [ Time Frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3 ]
    Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).

  2. Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period [ Time Frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection ]
    GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.

  3. Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine [ Time Frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3 ]
    Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.

  4. Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period [ Time Frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection ]
    Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.

  5. Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine [ Time Frame: 7 days post-each injection ]
    Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >= 5 cm.

  6. Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine [ Time Frame: 14 days post-each injection ]
    Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5 degree Celsius (°C) to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.



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Ages Eligible for Study:   2 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 2 to 45 years on the day of inclusion.
  • Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants <18 years).
  • Participant (and parent/guardian for participants <18 years) able to attend all scheduled visits and to comply with all trial procedures.
  • For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
  • Participant in good health, based on medical history, physical examination and laboratory parameters.

Exclusion Criteria :

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
  • For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
  • Breast-feeding female participant.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
  • Planned participation in another clinical trial during the first year of the study.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
  • Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
  • Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
  • 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.
  • Familial atopy medical history (parents, brothers, or sisters).
  • Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
  • History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875524


Locations
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Vietnam
Sanofi Pasteur Investigational Site
Long Xuyên, An Giang Province, Vietnam
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00875524     History of Changes
Other Study ID Numbers: CYD22
2014-001709-41 ( EudraCT Number )
First Posted: April 3, 2009    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases
Dengue vaccine
Additional relevant MeSH terms:
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Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs