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Completed

NCT Number: NCT00875524

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

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.

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Key information

Conditions

Dengue Virus Arbovirus Infections Dengue Dengue Disease Dengue Fever Dengue Hemorrhagic Fever Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Severe Dengue Vector Borne Diseases Virus Diseases

Age range

2 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi Pasteur Investigational Site

Long Xuyen, An Giang, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CYD dengue vaccine serotypes (1, 2, 3, 4).

Biological

0.5 mL, Subcutaneous

Other names: ChimeriVax™

Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Biological

Each at 0.5 mL, Subcutaneous, respectively

Other names: Meningococcal Polysaccharide Vaccine A+C, NaCl, Typhim Vi®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 3, 2009
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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