Clinical trial NCT00560755: Safety Study of ProQuad® rHA in Infants (V221-037)
Official title: An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Keywords: Prevention of: measles, mumps, rubella and varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 3388
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.

Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.


Eligibility criteria: Inclusion Criteria:

* Healthy subject of either gender,
* Age from 12 to 22 months,
* Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
* Informed consent form signed by the parent(s) or by legal representative
* Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

Exclusion Criteria:

* Recent (≤ 3 days) history of febrile illness
* Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
* Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
* Prior known sensitivity/allergy to any component of the vaccine
* Severe chronic disease,
* Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
* Humoral or cellular immunodeficiency,
* Current immunosuppressive therapy
* Family history of congenital or hereditary immunodeficiency
* Hereditary problems of fructose intolerance
* Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
* Known active tuberculosis
* Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
* Receipt of immunoglobulins or blood-derived products in the past 150 days
* Receipt of an inactivated vaccine in the past 14 days
* Receipt of a live vaccine in the past 28 days
* Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
* Participation in another clinical study in the past 30 days

Primary outcomes:
measure: Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
timeFrame: Up to Day 46 (for 4 days following ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
timeFrame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
timeFrame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
measure: Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
timeFrame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Secondary outcomes:
measure: Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
timeFrame: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)
measure: Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1
timeFrame: Up to Day 28 (28 days after ProQuad® Dose 1)
measure: Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1
timeFrame: Up to Day 28 (28 days after ProQuad® Dose 1)
measure: Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
timeFrame: Up to Day 28 (28 days after ProQuad® Dose 1)
Other outcomes:
Locations:
Study officials:
affiliation: MCM Vaccines B.V.
name: Anne FIQUET, MD
role: STUDY_DIRECTOR
References:
citation: Ruger G, Gabutti G, Rumke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Hogh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b.