Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers
NCT ID: NCT01411241
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
720 participants
INTERVENTIONAL
2011-07-18
2014-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
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
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).
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
9 Months
12 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur SA
Locations
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Acapulco de Juárez, Guerrero, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Mérida, Yucatán, Mexico
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1115-6290
Identifier Type: OTHER
Identifier Source: secondary_id
CYD33
Identifier Type: -
Identifier Source: org_study_id
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