Serological Study in Children 12 to 23 Months Vaccinated... | NCT01874457

Studies
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)

NCT01874457

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Status

Completed

Last Update Posted

Jun 17, 2013Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Mumps
Rubella
Measles

Interventions

MMR (Mumps, Measles and Rubella)

Countries

Brazil

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

Status Module

Record Verification Date

Jun 2013

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

May 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jun 7, 2013

First Submission Date that Met QC Criteria

Jun 10, 2013

First Posted Date

Jun 11, 2013Estimated

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

Jun 13, 2013

Last Update Posted Date

Jun 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.

Detailed Description

Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
MMR (Mumps, Measles and Rubella)	Biological	MMR (Mumps, Measles and Rubella)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunoresponse after first dose	Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.	42 days

Secondary Outcomes

Measure	Description	Time Frame
Immunoresponse after revaccination	To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.	42 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children of both sexes;
Age between 12 months to 23 months and 29 days;
Child in good health, with no significant past medical history;
Have completed blood sampling before vaccination;
Have not been vaccinated with MMR.
Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
Parents/Tutors able to understand the risks of the experiment, although minimal;
Parents/Tutors able to understand and sign the informed consent form.
Availability of return for collecting post-vaccination samples.

Exclusion criteria:

Children with a history of measles, rubella and / or mumps.
Having received MMR vaccine previously, as documented in vaccination card.
Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
Skin lesions at sites of venipuncture.
Child subject to abnormal bleeding after injections.
Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

24 Months

Standard Ages

Child

Study Population

Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of Rio de Janeiro.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Glória Regina da Silva e Sá, Doctorate	Immunobiological Technology Institute (Bio-Manguinhos)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bio-Manguinhos/Fiocruz		Rio de Janeiro	Rio de Janeiro	21040-360	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009107	Mumps
D012409	Rubella
D008457	Measles

Ancestor Terms

ID	Term
D019351	Rubulavirus 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
D022542	Measles-Mumps-Rubella Vaccine

Ancestor Terms

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided