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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01346293
First received: April 29, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 IPV 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.

Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Measles
Polio
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants demonstrating the booster response for each anti pertussis antibody [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Anti pertussis antibodies: Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Pertactin (PRN); Fimbriae Types 2 and 3 (FIM) measured by enzyme linked immunosorbent assay (ELISA).

  • Number of participants demonstrating the booster response for diphtheria and tetanus antibodies [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Booster response for diphtheria and tetanus antibodies measured by enzyme linked immunosorbent assay (ELISA).


Secondary Outcome Measures:
  • Information about Polio antibody titers for each polio antigen [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Anti poliovirus types 1, 2, and 3 titers will be determined by neutralization assay


Other Outcome Measures:
  • Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with the study vaccines [ Time Frame: Day 0 (post-vaccination) up to Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Redness, Swelling, Change in Limb Circumference, and Extensive Limb Swelling: Solicited Systemic reaction: Fever (Temperature) Headache, Malaise, and Myalgia.


Enrollment: 3372
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: 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®)
Other Names:
  • DTap-IPV
  • M-M-R®II
  • VARIVAX®
Experimental: 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
Biological: 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 Names:
  • DAPTACEL®
  • IPOL®
  • M-M-M R®II
  • VARIVAX®
Experimental: 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
Biological: 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®)
Other Names:
  • DTap-IPV
  • M-M-R®II
  • VARIVAX®
Experimental: 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
Biological: 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 Names:
  • DAPTACEL®
  • IPOL®
  • M-M-R®II
  • VARIVAX®

Detailed Description:

All participants will be randomized to receive either one dose each of DTap-IPV + Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® + IPOL® + M-M-R®II + VARIVAX® on Day 0.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 4 to < 7 years on the day of inclusion
  • 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:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346293

  Show 72 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01346293     History of Changes
Other Study ID Numbers: M5I02, U1111-1116-4842
Study First Received: April 29, 2011
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Tetanus
Diphtheria
Pertussis
DTap-IPV
DAPTACEL®
VARIVAX®

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Tetany
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on October 01, 2014