Immunogenicity and Reactogenicity of a Trivalent MMR (Trivivac) in Healthy Infants

NCT01763268 | Unknown Phase 2

• 1 other identifier: Trivivac2012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, single-arm trial, Primary Objectives included:

1. 1.To assess the immunogenicity of TrivivacTM administered in healthy infants aged between 9-14 months.
2. 2.To assess the safety (reactogenicity) of TrivivacTM administered in healthy infants aged between 9-14 months.

Conditions

Immunogenicity; Reactogenicity

Keywords

Immunogenicity; Reactogenicity; Trivivac; Measles; Mump; Rubella

Outcome Measures

Primary Outcomes (1)

• Immunogenicity as measured by the proportion of subjects achieving seroprotection against measles, mumps and rubella

  Immunogenicity of Trivivac vaccine is determined by proportion of subjects achieving seroprotection against measles, mumps and rubella at 6 weeks (42 days) after application of first dose of vaccine MMR. The amount of specific antibodies against measles, mumps and rubella will be evaluated in sera collected approximately 42+ 7 days following primary vaccination with the Trivivac vaccine. Seroconversion and GMT against measles, mumps, and rubella will be defined by Enzyme immunoassay for the qualitative detection and quantitative determination of specific IgG antibodies against measles, mumps and rubella virus in human serum (Enzygnost® Anti-Measles Virus/IgG, Anti-Mumps Virus/IgG and Anti-Rubella Virus/IgG; SIEMENS).

  6 weeks after vaccination

Secondary Outcomes (1)

• Reactogenicity as measured by the prevalence of local and systemic adverese reaction

  Day0 to day3 after vaccination

Study Arms (1)

Trivivac

EXPERIMENTAL

Children who receive Trivivac vaccine

Biological: Trivivac vaccine

Interventions

Trivivac vaccine BIOLOGICAL

Trivalent MMR vaccine

Trivivac

Eligibility Criteria

• Age: 9 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 9-14 months whose parents/LAR give written informed consent prior to the study entry.
• Infants with good health as determined by: Medical history, Physical examination, Clinical judgment of the investigator
• Infants who are not seroprotected against MMR virus by virtue of previous immunization and/or proven prior infection.

You may not qualify if:

• Children whom parents or LAR are unwilling or unable to give written informed consent to participate in the study.
• Any evidence of acute illness or infection within past 14 days.
• Planned or elective surgery during the course of the study.
• Infants born before the 37th week of gestation.
• Birth weight less than 2.5 kg.
• Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic corticosteroids) or those who have received a parenteral immunoglobulin preparation.
• Any history suggestive of thrombocytopenia or a bleeding disorder.
• Infants who have received any blood products (within 3 months prior to study entry), cytotoxic agents or radiotherapy.
• Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component (e.g. neomycin, gelatine, canine proteins).
• Infants with any serious chronic disease such as cardiac, autoimmune disease or insulin dependent diabetes or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives.
• Infants whose families are planning to leave the area of the study site before the end of the study period.

Sponsors & Collaborators

• Queen Sirikit National Institute of Child Health: lead

Study Sites (1)

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Measles; Rubella

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections

Central Study Contacts

Warunee P Vandepitte, MD, PhD

CONTACT

66855158299; waruneep@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dr.

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 8, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

TH (1)