Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
NCT ID: NCT01346293
Last Updated: 2015-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3372 participants
INTERVENTIONAL
2011-04-30
2013-09-30
Brief Summary
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Primary Objectives:
* To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose.
* To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose .
* To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
Observational Objectives:
* To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
* To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.
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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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Study Group 1
Participants will receive concomitantly a dose of DTap-IPV, a dose of M-M-R®II, and a dose of VARIVAX® vaccine on Day 0
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Study Group 2
Participants will receive concomitantly a dose of DAPTACEL®, a dose of IPOL®, a dose of M-M-R®II, and a dose of VARIVAX® vaccines on Day 0
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Study Group 3
Participants will receive concomitantly a dose of DTap-IPV with or without a dose of M-M-R®II and a dose of VARIVAX® on Day 0
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Study Group 4
Participants will receive concomitantly a dose of DAPTACEL® vaccine, a dose of IPOL® vaccine with or without a dose of M-M-R®II and a dose of VARIVAX® vaccines on Day 0
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Interventions
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Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated by the parent/guardian before the first study-related procedure
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
* Subject has documented completion of primary infant series and booster with DAPTACEL® and/or Pentacel® vaccine(s) only.
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for any influenza vaccine, which may be received at least 2 weeks before study vaccines
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination except for any influenza vaccine, which may be received at least 2 weeks after study vaccines
* Receipt of 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)
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* History of diphtheria, tetanus, or pertussis infection, confirmed either clinically, serologically, or microbiologically
* Known systemic hypersensitivity to any of the vaccines' 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
* Laboratory-confirmed thrombocytopenia, contraindicating intramuscular vaccination
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
* Identified as 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, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the investigator.
4 Years
6 Years
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 Inc.
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Pinson, Alabama, United States
Trussville, Alabama, United States
Chandler, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
La Puente, California, United States
Paramount, California, United States
Roseville, California, United States
Santa Clara, California, United States
West Covina, California, United States
Longmont, Colorado, United States
Thornton, Colorado, United States
St. Petersburg, Florida, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Overland Park, Kansas, United States
Topeka, Kansas, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Nicholasville, Kentucky, United States
Owensboro, Kentucky, United States
Bossier City, Louisiana, United States
Haughton, Louisiana, United States
Annapolis, Maryland, United States
Frederick, Massachusetts, United States
Woburn, Massachusetts, United States
Bridgeton, Missouri, United States
Bellevue, Nebraska, United States
Boys Town, Nebraska, United States
Lincoln, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Youngstown, Ohio, United States
Midwest City, Oklahoma, United States
Gresham, Oregon, United States
Collegeville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Scranton, Pennsylvania, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Clinton, Utah, United States
Layton, Utah, United States
Murray, Utah, United States
Orem, Utah, United States
Roy, Utah, United States
Springville, Utah, United States
Syracuse, Utah, United States
Burke, Virginia, United States
Charlottesville, Virginia, United States
Charlottesville, Virginia, United States
Charlottesville, Virginia, United States
Midlothian, Virginia, United States
Vienna, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Huntington, West Virginia, United States
San Juan, PR, Puerto Rico
Countries
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References
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Smith MJ, Jordanov E, Sheng X, Tsang PH. Safety and Immunogenicity of DTaP5-IPV Compared With DTaP5 Plus IPV as the Fifth Dose in Children 4-6 Years of Age. Pediatr Infect Dis J. 2017 Mar;36(3):319-325. doi: 10.1097/INF.0000000000001427.
Related Links
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Related Info
Other Identifiers
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U1111-1116-4842
Identifier Type: OTHER
Identifier Source: secondary_id
M5I02
Identifier Type: -
Identifier Source: org_study_id
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