Clinical trial NCT00402831: ProQuad® Intramuscular vs Subcutaneous
Official title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 405
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

* To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
* To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
* To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.


Eligibility criteria: Inclusion Criteria:

* Healthy participant of either gender,
* Age 12 to 18 months,
* Negative clinical history of measles, mumps, rubella, varicella and zoster,
* Consent form signed by both holders of the parental authority or by the legal representative
* Holder(s) of the the parental authority / 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
* Any recent (≤3 days) history of febrile illness
* Any severe chronic disease,
* Active untreated tuberculosis,
* Known personal history of seizure disorder,
* Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid \[any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days\] or other immunosuppressive therapy,
* Any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
* Any recent (≤7 days) tuberculin test or scheduled tuberculin test through Visit 3,
* Any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,

Primary outcomes:
measure: Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
timeFrame: Week 10 (6 weeks after Dose 2 on Week 4)
Secondary outcomes:
measure: Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
timeFrame: Week 4
measure: Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose
timeFrame: Week 4
measure: Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose
timeFrame: Week 4
measure: Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose
timeFrame: Week 4
measure: Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose
timeFrame: Week 4
measure: Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment
timeFrame: Week 10 (6 weeks after Dose 2 on Week 4)
measure: Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment
timeFrame: Week 10 (6 weeks after Dose 2 on Week 4)
measure: Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment
timeFrame: Week 10 (6 weeks after Dose 2 on Week 4)
measure: Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment
timeFrame: Week 10 (6 weeks after Dose 2 on Week 4)
measure: Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
timeFrame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
measure: Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
timeFrame: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
measure: Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose
timeFrame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Other outcomes:
Locations:
Study officials:
affiliation: SPMSD
name: Anne FIQUET, MD
role: STUDY_DIRECTOR
References:
citation: Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8.