ImmunogenicityPhase 2/3NCT01763268
Immunogenicity and Reactogenicity of a Trivalent MMR (Trivivac) in Healthy Infants
A Phase 2/3 study testing Trivivac vaccine in people with Immunogenicity and Reactogenicity, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Reactogenicity
- What is being tested?
- Trivivac vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2012to Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Queen Sirikit National Institute of Child Health
Bangkok, Bangkok, 10400
Warunee Punpanich Vandepitte, MD, PhD, 66855158299, waruneep@gmail.com
Warunee P Vandepitte, MD, PhD
About this study
Open-label, single-arm trial, Primary Objectives included:
- To assess the immunogenicity of TrivivacTM administered in healthy infants aged between 9-14 months.
- 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
- Being tested
- Trivivac vaccine
- Keywords
- Immunogenicity, Reactogenicity, Trivivac, Measles, Mump, Rubella
- Medical subject headings
- Measles, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivivac vaccineBiological
Trivalent MMR vaccine
| Study group | Role | What they receive |
|---|---|---|
| Trivivac | Experimental | Children who receive Trivivac vaccine Receives: Biological: Trivivac vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks after vaccination
Secondary outcomes (1)
Reactogenicity as measured by the prevalence of local and systemic adverese reaction
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.
Measured: Day0 to day3 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunogenicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit National Institute of Child Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Warunee Punpanich Vandepitte, Queen Sirikit National Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763268
- Sponsor's protocol ID
- Trivivac2012
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Reactogenicity of a Trivalent MMR (Trivivac) in Healthy Infants
- ClinicalTrials.gov ID
- NCT01763268
- Acronym / sponsor ID
- Trivivac2012
- Conditions
- Immunogenicity, Reactogenicity
- Keywords
- Immunogenicity, Reactogenicity, Trivivac, Measles, Mump, Rubella
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Sirikit National Institute of Child HealthOther government
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, single-arm trial, Primary Objectives included:
- To assess the immunogenicity of TrivivacTM administered in healthy infants aged between 9-14 months.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trivivac | Experimental | Biological: Trivivac vaccineChildren who receive Trivivac vaccine |
Who may qualify
- Ages
- 9 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivivac vaccineTrivalent MMR vaccine | Biological | Trivivac |
Primary outcome
Immunogenicity as measured by the proportion of subjects achieving seroprotection against measles, mumps and rubella
Time frame: 6 weeks after vaccination
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).
1 secondary outcome
Reactogenicity as measured by the prevalence of local and systemic adverese reaction
Time frame: Day0 to day3 after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trivivac vaccine in people with Immunogenicity and Reactogenicity, run by Queen Sirikit National Institute of Child Health at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Warunee P Vandepitte, MD, PhD (66855158299, waruneep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity as measured by the proportion of subjects achieving seroprotection against measles, mumps and rubella (time frame: 6 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.