search
Back to results

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

Primary Purpose

Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
CYD dengue vaccine serotypes (1, 2, 3, 4).
Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue Virus focused on measuring Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine

Eligibility Criteria

2 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Sanofi Pasteur Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CYD Dengue Vaccine Group

Control Vaccine Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
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
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
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
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
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.
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2009
Last Updated
March 15, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00875524
Brief Title
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Official Title
Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Disease
Keywords
Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CYD Dengue Vaccine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Vaccine Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CYD dengue vaccine serotypes (1, 2, 3, 4).
Other Intervention Name(s)
ChimeriVax™
Intervention Description
0.5 mL, Subcutaneous
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Other Intervention Name(s)
Meningococcal Polysaccharide Vaccine A+C, NaCl, Typhim Vi®
Intervention Description
Each at 0.5 mL, Subcutaneous, respectively
Primary Outcome Measure Information:
Title
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
Description
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame
Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Title
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Description
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Time Frame
Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Title
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
Description
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time Frame
Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Title
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
Description
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time Frame
Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Title
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Description
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.
Time Frame
7 days post-each injection
Title
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Description
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.
Time Frame
14 days post-each injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi Pasteur Investigational Site
City
Long Xuyên
State/Province
An Giang Province
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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://vivli.org

Learn more about this trial

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

We'll reach out to this number within 24 hrs