DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
NCT ID: NCT02094833
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2014-03-31
2016-11-30
Brief Summary
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Primary Objective
* To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid \[PT\] and filamentous haemagglutinin \[FHA\]) of Group A versus Group B, one month after the third dose of combined vaccines.
Secondary Objectives:
* To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.
* To study the safety after each and any dose of vaccines administered in the two vaccination schemes
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Participants will receive 3 injections of the study vaccine (DTaP-IPV-Hep B-PRP\~T combined vaccine) at 2, 4, and 6 months of age
DTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
Group B
Participants will receive 2 injections of monovalent Hep B vaccine (Euvax B®) at age 1 and 6 months and 3 injections of DTaP IPV//PRP\~T vaccine (Pentaxim™) at age 2, 4, and 6 months
DTaP-IPV//PRP~T and Hepatitis B vaccine
0.5 mL, Intramuscular
Interventions
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DTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
DTaP-IPV//PRP~T and Hepatitis B 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
* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
* Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
* Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available)
* Have received one documented dose of Hep B vaccine at birth according to the national recommendations.
Exclusion Criteria
* Receipt of any vaccine in the 4 weeks preceding any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
* Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
* Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically
* 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
* Known thrombocytopenia, as reported by the parent/legally acceptable representative
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
* In an emergency setting, or hospitalized involuntarily
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
* History of seizures.
1 Month
6 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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Daejeon, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Gyeongsangnam Do, , South Korea
Gyeongsangnam Do, , South Korea
Jeollabuk Do, , South Korea
Jeonbuk, , South Korea
Kangwon Do, , South Korea
Kyunggi Do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon Gyeonggi Do, , South Korea
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1127-6896
Identifier Type: OTHER
Identifier Source: secondary_id
A3L31
Identifier Type: -
Identifier Source: org_study_id
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