Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Invasive Hib Infections
MeSH terms: Hepatitis A; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Intervention: Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 8 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; DTaP IPV-Hep B-PRP~T combined vaccine (Hexaxim™)

Summary:

      The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV-
      Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14
      weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface
      antigen (HBsAg) serology negative in India.

      Primary Objective:

        -  To evaluate the immunogenicity of the study vaccine in terms of seroprotection
           [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae
           type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for
           pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one
           month after the third dose.

      Secondary Objectives:

        -  To further describe the immunogenicity of the study vaccine, before the first dose and
           one month after the third dose.

        -  To describe the safety after each and any doses of the study vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 42-56 days (6 to 8 weeks) on the day of inclusion

          -  Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg

          -  Informed consent form signed by the parent(s) or any other legally acceptable
             representative

          -  Subject and parent/legally acceptable representative are able to attend all scheduled
             visits and to comply with all trial procedures

          -  Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented
             laboratory result of HBsAg assay from maternal blood sample performed during last
             trimester of pregnancy available)

          -  Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV)
             from birth as per national recommendations.

        Exclusion Criteria:

          -  Participation in another clinical trial in the 4 weeks preceding the trial inclusion
             or planned participation during the present trial period in another clinical trial
             investigating a vaccine, drug, medical device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except
             Bacillus Calmette-Guerin [BCG] vaccine) or planned receipt of any other vaccine within
             the period from 8 days before to 8 days after each subsequent trial vaccination

          -  Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect
             the birth dose of OPV as per national recommendations) and hepatitis B (except the
             birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or
             another vaccine

          -  Past or current receipt of immune globulins, blood or blood-derived products or
             planned administration during the trial

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since
             birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more
             than 2 consecutive weeks since birth)

          -  History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib
             infections (confirmed either clinically, serologically or microbiologically)

          -  Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis
             C seropositivity

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the trial vaccine or a vaccine containing the same
             substances

          -  Known thrombocytopenia, as reported by the parent/legally acceptable representative

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination

          -  In an emergency setting, or hospitalized involuntarily

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (axillary temperature ≥38°C) on the day of
             inclusion (a prospective subject should not be included in the study until the
             condition has resolved or the febrile event has subsided)

          -  Identified as a natural or adopted child of the Investigator, relatives or employee
             with direct involvement in the proposed study

          -  History of seizures.