Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Condition: Varicella; Measles; Mumps; Rubella; Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Diphtheria; Measles; Chickenpox; Herpes Zoster; Poliomyelitis; Rubella; Haemophilus Infections
Intervention: ProQuad®; Infanrix® hexa
Intervention description: Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose [CCID]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units [PFU]).; Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 955.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mumps and Rubella; Haemophilus influenzae type b (Infanrix® hexa)

Summary:

      Primary Objective:

        -  To demonstrate that ProQuad® can be administered concomitantly with a booster dose of
           Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the
           antibody response rates to measles, mumps, rubella, varicella, hepatitis B and
           Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days
           following vaccination.

      Secondary Objectives:

        -  To describe the antibody titres and the antibody response rates to measles, mumps,
           rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
           Haemophilus influenzae type b as measured at 42 days following vaccination by an
           Infanrix® hexa primary series schedule and all data are pooled.

        -  To evaluate the safety profile of ProQuad® when administered concomitantly with a
           booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data
           are pooled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of either gender

          -  Aged 12 to 23 months

          -  No clinical history of measles, mumps, rubella, varicella and zoster

          -  For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis,
             hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as
             a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion

          -  For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis,
             hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as
             a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion

          -  Consent form signed by parent(s) according to local regulations or by the legal
             representative properly informed about the study

          -  Parent(s)/legal representative able to understand the protocol requirements and to
             fill in the Diary Card.

        Exclusion Criteria:

          -  Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in
             any combination

          -  Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster

          -  Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or
             Haemophilus influenzae type b containing vaccine (either alone or in any combination)
             than Infanrix® hexa

          -  Any recent (<= 3 days) history of febrile illness

          -  Any severe chronic disease

          -  Active untreated tuberculosis

          -  Known personal history of encephalopathy, seizure disorder or progressive, evolving or
             unstable neurological condition

          -  Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant
             neoplasms affecting the haematopoietic or lymphatic systems

          -  Any severe thrombocytopenia or any other coagulation disorder that would
             contraindicate intramuscular injection

          -  Prior known sensitivity/allergy to any component of the vaccines including neomycin,
             sorbitol or gelatin

          -  Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
             immunity

          -  Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2

          -  Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived
             products or scheduled to be administered through Visit 2

          -  Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or
             scheduled non-study vaccination through Visit 2

          -  Any medical condition which, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives

          -  Any recent (≤30 days) participation or scheduled participation in any other clinical
             trial through Visit 2