Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

NCT01346293 | Completed Phase 3 Results

• 2 other identifiers: M5I02U1111-1116-4842
• Study Type: interventional
• Target: 3,372
• Locations: 2 countries
• Sites: 72

Brief Summary

The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. 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.

Conditions

Tetanus; Diphtheria; Pertussis; Measles; Polio

Keywords

Tetanus; Diphtheria; Pertussis; DTap-IPV; DAPTACEL®; VARIVAX®

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Geometric mean concentrations to pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], and fimbriae types 2 and 3 \[FIM\]) were measured by enzyme-linked immunosorbent assay (ELISA).

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration \<0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but \<2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration \<1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Other Outcomes (5)

• Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Study Arms (4)

Study Group 1

EXPERIMENTAL

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

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus

Study Group 2

EXPERIMENTAL

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

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus

Study Group 3

EXPERIMENTAL

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

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus

Study Group 4

EXPERIMENTAL

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

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus

Interventions

Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus BIOLOGICAL

0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)

Also known as: DTap-IPV, M-M-R®II, VARIVAX®

Study Group 1

Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus BIOLOGICAL

0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®

Also known as: DAPTACEL®, IPOL®, M-M-M R®II, VARIVAX®

Study Group 2

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (72)

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Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35235, United States

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Birmingham, Alabama, 35244, United States

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Pinson, Alabama, 35126, United States

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Trussville, Alabama, 35173, United States

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Chandler, Arizona, 85224, United States

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Scottsdale, Arizona, 85255, United States

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Scottsdale, Arizona, 85258, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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La Puente, California, 91744, United States

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Paramount, California, 90723, United States

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Roseville, California, 95661, United States

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Santa Clara, California, 95051, United States

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West Covina, California, 91790, United States

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Longmont, Colorado, 80501, United States

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Thornton, Colorado, 80233, United States

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St. Petersburg, Florida, 33713, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Indianapolis, Indiana, 46256, United States

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New Albany, Indiana, 47150, United States

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Overland Park, Kansas, 66213, United States

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Topeka, Kansas, 66604, United States

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Crestview Hills, Kentucky, 41017, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Nicholasville, Kentucky, 40356, United States

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Owensboro, Kentucky, 42303, United States

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Bossier City, Louisiana, 71111, United States

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Haughton, Louisiana, 71037, United States

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Annapolis, Maryland, 21401, United States

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Frederick, Massachusetts, 21702, United States

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Woburn, Massachusetts, 01801, United States

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Bridgeton, Missouri, 63044, United States

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Bellevue, Nebraska, 68005, United States

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Boys Town, Nebraska, 68010, United States

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Lincoln, Nebraska, 68504, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68198, United States

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Brooklyn, New York, 11201, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45245, United States

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Fairfield, Ohio, 45014, United States

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Youngstown, Ohio, 44505, United States

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Midwest City, Oklahoma, 73110, United States

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Gresham, Oregon, 97030, United States

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Collegeville, Pennsylvania, 19426, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Scranton, Pennsylvania, 18510, United States

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Bristol, Tennessee, 37620, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77025, United States

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San Antonio, Texas, 78229, United States

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Clinton, Utah, 84015, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84107, United States

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Orem, Utah, 84057, United States

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Roy, Utah, 84067, United States

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Springville, Utah, 84663, United States

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Syracuse, Utah, 84075, United States

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Burke, Virginia, 22015, United States

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Charlottesville, Virginia, 22902, United States

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Charlottesville, Virginia, 22903, United States

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Charlottesville, Virginia, 22911, United States

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Midlothian, Virginia, 23113, United States

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Vienna, Virginia, 22180, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99218, United States

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Huntington, West Virginia, 25701, United States

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San Juan, PR, 00918, Puerto Rico

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Related Publications (1)

• 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.

  PMID: 27879555 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough; Measles; Poliomyelitis

Interventions

Tetanus Toxoid; Chickenpox Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Herpesvirus Vaccines; Viral Vaccines; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 3, 2015
• Results First Posted: May 29, 2015

Record last verified: 2015-05

Locations

US (71); PR (1)