Clinical trial NCT00432042: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Measles
Mumps
Rubella
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Infections
Keywords: Mumps and Rubella
Haemophilus influenzae type b (Infanrix® hexa)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-06
Enrollment: 955
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella
timeFrame: Day 42
measure: Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B
timeFrame: Day 42
measure: Post-vaccination Geometric Mean Titres (GMT) to Pertussis
timeFrame: Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Alsfeld
country: Germany
city: Bad Saulgau
country: Germany
city: Bad Sobernheim
country: Germany
city: Bad Säckingen
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Birkenfeld
country: Germany
city: Bramsche
country: Germany
city: Bretten
country: Germany
city: Brunsbüttel
country: Germany
city: Datteln
country: Germany
city: Detmold
country: Germany
city: Espelkamp
country: Germany
city: Ettenheim
country: Germany
city: Friedrichshafen
country: Germany
city: Gerolstein
country: Germany
city: Gifhorn
country: Germany
city: Gütersloh
country: Germany
city: Hamburg
country: Germany
city: Heilbronn
country: Germany
city: Herbolzheim
country: Germany
city: Karlsruhe
country: Germany
city: Kehl
country: Germany
city: Koblenz
country: Germany
city: Lauffen
country: Germany
city: Mannheim
country: Germany
city: Marbach
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: Neustadt A.d. Aisch
country: Germany
city: Nidderau
country: Germany
city: Oberhausen
country: Germany
city: Oberkirch
country: Germany
city: Offenburg
country: Germany
city: Pegnitz
country: Germany
city: Rodorf
country: Germany
city: Schwieberdingen
country: Germany
city: Schwäbisch Hall
country: Germany
city: Traunreut
country: Germany
city: Veitshöchheim
country: Germany
city: Wanzleben
country: Germany
city: Welzheim
country: Germany
city: Wildeshausen
country: Germany
city: Zwiesel
country: Germany
city: Chiavari
country: Italy
city: Ferrara
country: Italy
city: Latisana
country: Italy
city: Ragusa
country: Italy
city: Sassari
country: Italy
city: Taranto
country: Italy
Study officials:
affiliation: SPMSD
name: Anne Fiquet, MD
role: STUDY_DIRECTOR
References:
citation: Deichmann KA, Ferrera G, Tran C, Thomas S, Eymin C, Baudin M. Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad (R)) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants. Vaccine. 2015 May 11;33(20):2379-86. doi: 10.1016/j.vaccine.2015.02.070. Epub 2015 Mar 9.