- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411241
Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers
March 15, 2022 updated by: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
- Biological: DTaP IPV//Hib vaccine
- Biological: Placebo
- Biological: Measles, mumps, and rubella vaccine
- Biological: Pneumococcal vaccine
- Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
- Biological: Placebo
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
720
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guerrero
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Acapulco, Guerrero, Mexico, CP 39670
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Jalisco
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Guadalajara, Jalisco, Mexico, CP 44280
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, CP 64460
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Yucatan
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Merida, Yucatan, Mexico, CP 97000
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 4 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CYD Dengue Vaccine Group 1
Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
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0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
Other Names:
0.5 mL, intramuscular
Other Names:
0.5 mL, subcutaneous
Other Names:
0.5 mL, subcutaneous
Other Names:
0.5 mL, intramuscular
Other Names:
0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
Other Names:
0.5 mL, subcutaneously
Other Names:
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Experimental: CYD Dengue Vaccine Group 2
Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
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0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
Other Names:
0.5 mL, intramuscular
Other Names:
0.5 mL, subcutaneous
Other Names:
0.5 mL, subcutaneous
Other Names:
0.5 mL, intramuscular
Other Names:
0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
Other Names:
0.5 mL, subcutaneously
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 28 days post-injection
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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).
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28 days post-injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Pre-injection 1 and 28 days post-injection 2 and 3
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Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT).
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Pre-injection 1 and 28 days post-injection 2 and 3
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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
Time Frame: Pre-injection 1 and 28 days post-injection 2 and 3
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Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT.
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Pre-injection 1 and 28 days post-injection 2 and 3
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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
Time Frame: Pre-injection 1 and 28 days post-injection 2 and 3
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Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT.
Seropositivity was defined as antibody titers >=10 (1/dilution).
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Pre-injection 1 and 28 days post-injection 2 and 3
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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
Time Frame: Pre-injection 1 and 28 days post-injection 2 and 3
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Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT.
Seropositivity was defined as antibody titers >=10 (1/dilution).
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Pre-injection 1 and 28 days post-injection 2 and 3
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Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine
Time Frame: Day 0 up to Day 14 post-first injection
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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.
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Day 0 up to Day 14 post-first injection
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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
Time Frame: Day 0 up to Day 14 post-booster injection
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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.
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Day 0 up to Day 14 post-booster injection
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Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine
Time Frame: Day 0 up to Day 14 post-second injection
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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.
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Day 0 up to Day 14 post-second injection
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Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine
Time Frame: Day 0 up to Day 14 post-third injection
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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.
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Day 0 up to Day 14 post-third injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2011
Primary Completion (Actual)
February 4, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 3, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 8, 2011
Study Record Updates
Last Update Posted (Actual)
March 25, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYD33
- U1111-1115-6290 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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