Dengue Fever Dengue Hemorrhagic Fever
Conditions
Interventions
Trade Name: Dengvaxia
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Live, attenuated, tetravalent dengue virus vaccine
Other descriptive name: DENGUE TETRAV
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Has been identified as a potential subject by the Sponsor, and is included in the list provided to the investigator (i.e., aged 9 to 45 years on the day of first injection of CYD dengue vaccine in CYD28, has received 3 doses of CYD dengue vaccine in the CYD28 trial, and has a post-Dose 3 serum sample available). Presently in good health, based on medical history and physical examination. Informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF 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 and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject who received any other dengue vaccination that was not part of CYD28 Subject is pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination Receipt of immune globulins, blood or blood-derived products in the past 3 months Known 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines 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 Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily Current alcohol abuse or drug addiction Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GTMR) of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from CYD 28 trial (subjects from Group 1 only).;Secondary Objective: If the primary objective of non-inferiority is achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in subjects from CYD28 trial (subjects from Group 1 only). To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in subjects who received three doses of the CYD dengue vaccine in the CYD28 trial in all subjects. To describe the neutralizing Abs levels of each dengue serotype post-dose 3 (CYD28 subjects) and immediately prior to booster or placebo injection in all subjects. To describe the neutralizing Ab persistence 6 months, 1 year and 2 years post booster or placebo injection in all study subjects. To evaluate the safety of booster vaccination with CYD dengue vaccine in all study subjects. ;Primary end point(s): Neutralizing antibody levels against each dengue virus serotype measured 28 days after the third CYD dengue vaccine injection and 28 days after the booster injection in the CYD Dengue Vaccine Group Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).;Timepoint(s) of evaluation of this end point: [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Neutralizing antibody levels against each of the four parental dengue virus strains of the CYD dengue vaccine as determined by PRNT immediately prior and 28 days post booster or placebo injection Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). 2. Number of subjects with seroconversion 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). Seroconversion is percentage of subjects with either a pre-booster titer < 10 (1/dil) and a post-booster titer = 40 (1/dil), or a pre-booster titer = 10 (1/dil) and a = 4-fold increase in post-booster titer 3.Summary of neutralizing antibody levels against each of the four parental dengue virus strains after the third CYD dengue vaccine injection and immediately prior to booster or placebo injection Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). 4. Summary of neutralizing antibody levels against each of the four parental dengue virus strains at 6 months, 1 year and 2 years post booster or placebo injection Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). 5. Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia ;Timepoint(s) of evaluation of this end point: 1. [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ] 2. [ Time Frame: Day 0 (pre-vaccination) an | — |
Countries
Singapore
Contacts
Public ContactTrial Transparency Team
Sanofi Pasteur
Outcome results
None listed