Safety Study of ProQuad® rHA in Infants (V221-037)

September 18, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ProQuad®
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
Biological: ProQuad®
ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
Time Frame: Up to Day 46 (for 4 days following ProQuad® Dose 2)
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
Up to Day 46 (for 4 days following ProQuad® Dose 2)
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)
The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Up to Day 84 (up to 42 days after ProQuad® Dose 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
Time Frame: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1
Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1)
Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.
Up to Day 28 (28 days after ProQuad® Dose 1)
Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1
Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1)
The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.
Up to Day 28 (28 days after ProQuad® Dose 1)
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1)
Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.
Up to Day 28 (28 days after ProQuad® Dose 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne FIQUET, MD, MCM Vaccines B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V221-037
  • MRV01C (Other Identifier: Sanofi Pasteur MSD Protocol Number)
  • 2007-002438-12 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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