Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
Condition: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis
Intervention: Quinvaxem; Quinvaxem/Tritanrix
Intervention description: A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at Weeks 6, 10 and 14; A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at Weeks 6, 10 and 14
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 400.0
Sex: All
Minimum age: 42 Days
Maximum age: 64 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity

Summary:

      This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by
      Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for
      all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface
      antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and
      anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 42 and 64 days of age at the time of the
             first vaccination

          -  Written informed consent obtained from parents/legal guardian of the subject

          -  Free of obvious health problems as established by medical history and/or clinical
             examination before entering the study

          -  Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study
             visits

        Exclusion Criteria:

          -  Use of any investigational drug or any investigational vaccine within 30 days
             preceding the first dose of study vaccine, or planned use during the study period and
             safety follow-up

          -  Planned administration of a vaccine not foreseen by the study protocol

          -  Known or suspected impairment of immune function, known Human immunodeficiency virus
             (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic
             immunosuppressive therapy within 1 month prior to study entry (note: inhaled and
             topical steroids are allowed)

          -  Administration of parenteral immunoglobulin preparation and/or blood products since
             birth

          -  Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria,
             tetanus, pertussis (DTP)

          -  History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine
             component or to products containing mercury compounds, such as sodium
             ethylmercuro-thiosalicylate

          -  Significant acute infection

          -  Any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives

          -  Participation in another clinical study