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

NCT ID: NCT01763268

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Trivivac

Children who receive Trivivac vaccine

Group Type: EXPERIMENTAL

Trivivac vaccine

Intervention Type: BIOLOGICAL

Trivalent MMR vaccine

Interventions

Trivivac vaccine

Trivalent MMR vaccine

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Sirikit National Institute of Child Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Warunee Punpanich Vandepitte

Assistant Professor, Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Warunee P Vandepitte, MD, PhD

Role: CONTACT

waruneep@gmail.com

66855158299

Facility Contacts

Warunee Punpanich Vandepitte, MD, PhD

Role: primary

waruneep@gmail.com

66855158299

Other Identifiers

Trivivac2012

Identifier Type: -

Identifier Source: org_study_id