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

April 29, 2011
November 18, 2013
April 2011
May 2013   (final data collection date for primary outcome measure)
  • 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).
  • Information on the 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).
  • Information about number of subjects 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).
Complete list of historical versions of study NCT01346293 on ClinicalTrials.gov Archive Site
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
Same as current
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.
Not Provided
 
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Tetanus
  • Diphtheria
  • Pertussis
  • Measles
  • Polio
  • 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®
  • 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®
  • 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®
  • 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
    Intervention: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
  • 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
    Intervention: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
  • 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
    Intervention: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
  • 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
    Intervention: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3372
September 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
4 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01346293
M5I02, U1111-1116-4842
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP