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

NCT01763268 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-08

No results posted yet for this study

Summary

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

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

The study will be done on healthy infants, 9-14 months of age. After enrolment, the infants will be given one dose of primary vaccination MMR (TrivivacTM),SEVAPHARMA BiogenetechLtd. study vaccines will be administered subcutaneously into the anterolateral aspect of right thigh.outer aspect of the upper arm. Subjects will be followed at approximately 6 weeks after primary vaccination to evaluate response to primary immunization of this vaccine. Blood sample will be collected from subjects at visit 1 (prior to immunization) and visit 2 (6 weeksone month after completion of this first dose of immunization). The serum samples will be analysed for Anti-measles, Anti-mumps and Anti-rubella antibodies. Proportion of subjects achieving seroprotection and geometric mean titers of antibody against measles, mumps, rubella at 6 weeks after one dose vaccination of MMR vaccine at aged 9-14 months will be evaluated. Adverse reactions will be observed on each vaccination day (up to 30 minutes) and for 4 days (Day 0-3) after each dose. Adverse reactions will also be monitored for 30 days following each vaccination. Serious adverse events will be monitored for the entire study duration.

Conditions

  • Immunogenicity
  • Reactogenicity

Interventions

BIOLOGICAL

Trivivac vaccine

Trivalent MMR vaccine

Sponsors & Collaborators

  • Queen Sirikit National Institute of Child Health

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-01-31
Completion
2015-08-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01763268 on ClinicalTrials.gov