Phase 3
Completed N=3,388
Safety Study of ProQuad® rHA in Infants (V221-037)
Source: ClinicalTrials.gov NCT00560755 ↗Enrolled (actual)
3,388
Serious AEs
0.9%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 — 57.66 Percentage of Participants
◆ Published Evidence
Emerging
9citations · ~1 / year
Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin.
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.
Linked Publications
-
Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 |
57.66 | — |
| PRIMARY Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 |
41.77 | — |
| PRIMARY Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 |
30.46; 13.23; 11.49 | — |
| PRIMARY Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 |
1.65 | — |
| PRIMARY Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 |
0.03 | — |
| PRIMARY Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 |
40.42 | — |
| PRIMARY Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 |
13.44 | — |
| PRIMARY Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 |
1.62; 0.57; 0.63; 0.03 | — |
| PRIMARY Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 |
0.03 | — |
| PRIMARY Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 |
0.66 | — |
| PRIMARY Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 |
0.21 | — |
| SECONDARY Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1 |
14.31; 5.57; 10.31 | — |
| SECONDARY Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1 |
7.43 | — |
| SECONDARY Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1 |
56.10 | — |
| SECONDARY Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1 |
64.10 | — |
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
Data sourced from ClinicalTrials.gov (NCT00560755) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.