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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Queen Sirikit National Institute of Child Health
Sponsor:
Information provided by (Responsible Party):
Warunee Punpanich Vandepitte, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier:
NCT01763268
First received: January 3, 2013
Last updated: January 5, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Immunogenicity
Reactogenicity
Biological: Trivivac vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Queen Sirikit National Institute of Child Health:

Primary Outcome Measures:
  • Immunogenicity as measured by the proportion of subjects achieving seroprotection against measles, mumps and rubella [ Time Frame: 6 weeks after vaccination ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Reactogenicity as measured by the prevalence of local and systemic adverese reaction [ Time Frame: Day0 to day3 after vaccination ] [ Designated as safety issue: Yes ]
    Occurrence, intensity and relationship to vaccination of early expected and unexpected local and systemic adverse drug reactions reported during the 4-day (Day 0-3) follow-up period after vaccination.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trivivac
Children who receive Trivivac vaccine
Biological: Trivivac vaccine
Trivalent MMR vaccine

  Eligibility

Ages Eligible for Study:   9 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Children whom parents or LAR are unwilling or unable to give written informed consent to participate in the study.
  2. Any evidence of acute illness or infection within past 14 days.
  3. Planned or elective surgery during the course of the study.
  4. Infants born before the 37th week of gestation.
  5. Birth weight less than 2.5 kg.
  6. 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.
  7. Any history suggestive of thrombocytopenia or a bleeding disorder.
  8. Infants who have received any blood products (within 3 months prior to study entry), cytotoxic agents or radiotherapy.
  9. Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component (e.g. neomycin, gelatine, canine proteins).
  10. 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.
  11. Infants whose families are planning to leave the area of the study site before the end of the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763268

Contacts
Contact: Warunee P Vandepitte, MD, PhD 66855158299 waruneep@gmail.com

Locations
Thailand
Queen Sirikit National Institute of Child Health Recruiting
Bangkok, Thailand, 10400
Contact: Warunee Punpanich Vandepitte, MD, PhD    66855158299    waruneep@gmail.com   
Principal Investigator: Warunee P Vandepitte, MD, PhD         
Sponsors and Collaborators
Queen Sirikit National Institute of Child Health
  More Information

No publications provided

Responsible Party: Warunee Punpanich Vandepitte, Assistant Professor, Dr., Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier: NCT01763268     History of Changes
Other Study ID Numbers: Trivivac2012
Study First Received: January 3, 2013
Last Updated: January 5, 2013
Health Authority: Thailand: Queen Sirikit National Institute of Child Health

Keywords provided by Queen Sirikit National Institute of Child Health:
Immunogenicity
Reactogenicity
Trivivac
Measles
Mump
Rubella

ClinicalTrials.gov processed this record on October 19, 2014