Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Condition: Tetanus; Diphtheria; Pertussis; Measles; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Intervention description: 0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®); 0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®; 0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®); 0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3372.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tetanus; Diphtheria; Pertussis; DTap-IPV; DAPTACEL®; VARIVAX®

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.
    

Eligibility 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.