Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Brief Title

Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Official Title

An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of Concomitant Versus Separate Administration of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) and a Booster Dose of Infanrix® Hexa in Healthy Children 12 to 23 Months of Age

Brief 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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella

Condition

Varicella

Intervention

ProQuad®

Study Arms / Comparison Groups

 ProQuad® + Infanrix® hexa

Description:  Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

955

Start Date

January 12, 2007

Completion Date

March 27, 2008

Primary Completion Date

March 27, 2008

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
      

Gender

All

Ages

12 Months - 23 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anne Fiquet, MD, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT00432042

Organization ID

V221-035

Secondary IDs

X06-MMRV-302

Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme LLC

Study Sponsor

Anne Fiquet, MD, Study Director, SPMSD

Verification Date

February 2018