A Measles, Mumps, and Rubella Investigational Vaccine Tri... | NCT00109278

Studies
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

NCT00109278

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Mar 15, 2017Actual

Enrollment

1,100Actual

Phase

Phase 2

Conditions

Measles

Interventions

V205C, measles, mumps, and rubella virus vaccine live
Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005_016

Official Title

A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Apr 26, 2005

First Submission Date that Met QC Criteria

Apr 25, 2005

First Posted Date

Apr 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2017

Last Update Posted Date

Mar 15, 2017Actual

Description Module

Brief Summary

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

Detailed Description

The duration of treatment is 6 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V205C, measles, mumps, and rubella virus vaccine live	Biological
Comparator: Measles, Mumps, and Rubella Virus Vaccine Live	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibody response rate to measles at 6 weeks postvaccination

Secondary Outcomes

Measure	Description	Time Frame
Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children 12 to 18 months of age.

Exclusion Criteria:

Previous receipt of measles, mumps, rubella and/or varicella vaccine.
Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
History of seizures (convulsions)
Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

ID	Type	URL	Comment
	CSR Synopsis	View IPD

Condition Browse Module

MeSH Terms

ID	Term
D008457	Measles

Ancestor Terms

ID	Term
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012411	Rubella Vaccine

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided