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 Information
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
Administrative Informations
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