Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01411241
Other study ID # CYD33
Secondary ID U1111-1115-6290
Status Completed
Phase Phase 3
First received
Last updated
Start date July 18, 2011
Est. completion date April 2014

Study information

Verified date March 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day visit but in 2 different sites of administration. Primary Objective: - To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo. Secondary Objectives: - To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo. - To describe the safety of the CYD dengue vaccine after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06). - To describe the safety of the CYD dengue vaccine in all participants after each dose. - To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine (at Visit 05) or administered alone (at Visit 06). - To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.


Description:

Participants required 8 or 9 clinic visits and received a total of 7 injections. The dengue post-vaccinal viremia was assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity was assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. Participants were followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.


Recruitment information / eligibility

Status Completed
Enrollment 720
Est. completion date April 2014
Est. primary completion date February 4, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 12 Months
Eligibility Inclusion Criteria: - Aged 9 to 12 months on the day of inclusion. - Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg. - Participant in good health, based on medical history and physical examination. - Documentation of completion of the primary vaccination series with Pentaxim vaccine with the 3 doses received between 2 and 8 months of age. - Informed consent form had been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations). - Participant and parent/guardian attended all scheduled visits and 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 any trial vaccination. - Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Hib and/or polio. - 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 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). - Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as reported by the parent(s)/legally acceptable representative. - History of pertussis and/or Hib infection as reported by the parent(s)/legally acceptable representative. - 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. - History of contraindication to the receipt of vaccines containing components of Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin, polyribosylribitol phosphate [PRP] and polio) or of measles, mumps and rubella vaccine and of pneumococcal vaccine. - Thrombocytopenia, as reported by the parent(s)/legally acceptable representative. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. - History of central nervous system disorder or disease, including seizures. - 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 site 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
DTaP IPV//Hib vaccine
0.5 mL, intramuscular
Placebo
0.5 mL, subcutaneous
Measles, mumps, and rubella vaccine
0.5 mL, subcutaneous
Pneumococcal vaccine
0.5 mL, intramuscular
Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
DTaP IPV//Hib vaccine
0.5 mL, intramuscular
Placebo
0.5 mL, subcutaneously
Measles, mumps, and rubella vaccine
0.5 mL, subcutaneous
Pneumococcal vaccine
0.5 mL, intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as >=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, >=8 1/dil for poliovirus types 1, 2, and 3, and >=1.0 µg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were < lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels >=4* LLOQ; participants whose pre-vaccination Ab concentrations were >=LLOQ but <4* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels >=4); for participants whose pre-vaccination Ab concentrations were >=4* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination >=2). 28 days post-injection
Secondary Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT). Pre-injection 1 and 28 days post-injection 2 and 3
Secondary Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT. Pre-injection 1 and 28 days post-injection 2 and 3
Secondary Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). Pre-injection 1 and 28 days post-injection 2 and 3
Secondary Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). Pre-injection 1 and 28 days post-injection 2 and 3
Secondary Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 3 Solicited injection site reactions: Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5 degree Celsius (°C); Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: Sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Day 0 up to Day 14 post-first injection
Secondary Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable; and Extensive swelling, severe. Day 0 up to Day 14 post-booster injection
Secondary Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Day 0 up to Day 14 post-second injection
Secondary Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Day 0 up to Day 14 post-third injection
See also
  Status Clinical Trial Phase
Completed NCT05321264 - Educational Intervention to Promote Control Behaviors and Prevention of Dengue N/A
Completed NCT01436396 - Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers Phase 3
Completed NCT01391819 - Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children N/A
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02833584 - Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults N/A
Completed NCT02433652 - Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2 Phase 1
Enrolling by invitation NCT02016027 - Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter Phase 1
Completed NCT01477671 - Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children N/A
Recruiting NCT00377754 - Prospective Study of Infant Dengue N/A
Recruiting NCT05919277 - A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
Recruiting NCT04582474 - Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso N/A
Completed NCT01983553 - Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Completed NCT03803618 - Dengue Effectiveness Study in the Philippines
Active, not recruiting NCT05967455 - Homologous Re-infection With Dengue 1 or Dengue 3 Phase 1
Completed NCT03631719 - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Recruiting NCT02606019 - The Use of Biomarkers in Predicting Dengue Outcome N/A
Completed NCT02372175 - Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain Phase 1
Active, not recruiting NCT01696422 - Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine Phase 2
Completed NCT00993447 - Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America Phase 2
Completed NCT00375726 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults Phase 1

External Links