MeaslesPhase 4NCT00313950
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
A Phase 4 study testing Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella and Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine in people with Measles and Mumps, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).
Trial summary
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella. Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- What is being tested?
- Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella and Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2006to Apr 2010
- Phase
- Phase 4
- 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 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12-13 months on the day of inclusion
- Born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures
- Subjects having received only one or no injection of vaccine against Measles
- Subjects anti-HAV seronegative according to the results obtained at the screening visit*
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the past 3 months
Show all 14Show fewer
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following any trial vaccination
- History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against hepatitis A with the trial vaccine or another vaccine
- Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Febrile illness (axillary temperature ≥37.4°C]) on the day of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.
- Conditions
- Measles, Mumps, Rubella, Hepatitis A
- Being tested
- Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella, Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
- Keywords
- measles, rubella, mumps, hepatitis A
- Medical subject headings
- Measles, Mumps, Rubella, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Hep A vaccine; Attenuated Measles Mumps RubellaBiological
Also called AVAXIM™, TRIMOVAX™
0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
Attenuated Measles Mumps Rubella; Inactivated Hep A vaccineBiological
Also called TRIMOVAX™, AVAXIM™
0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
Inactivated Hep A vaccine; Attenuated Measles Mumps RubellaBiological
Also called AVAXIM™, TRIMOVAX™
0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella |
| Group 2 | Experimental | Not described Receives: Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine |
| Group 3 | Experimental | Not described Receives: Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
Measured: Day 7 - Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313950
- Sponsor's protocol ID
- HAF65
- Status last verified
- Jan 2014
- First submitted
- 11 Apr 2006
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children
- ClinicalTrials.gov ID
- NCT00313950
- Acronym / sponsor ID
- HAF65
- Conditions
- Measles, Mumps, Rubella, Hepatitis A
- Keywords
- measles, rubella, mumps, hepatitis A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Apr 2006 (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.
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella |
| Group 2 | Experimental | Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine |
| Group 3 | Experimental | Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 12-13 months on the day of inclusion
- Born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures
- Subjects having received only one or no injection of vaccine against Measles
Key exclusion criteria (14 listed)
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
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 |
|---|---|---|
| Inactivated Hep A vaccine; Attenuated Measles Mumps RubellaAlso: AVAXIM™, TRIMOVAX™0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28) | Biological | Group 1 |
| Attenuated Measles Mumps Rubella; Inactivated Hep A vaccineAlso: TRIMOVAX™, AVAXIM™0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168) | Biological | Group 2 |
| Inactivated Hep A vaccine; Attenuated Measles Mumps RubellaAlso: AVAXIM™, TRIMOVAX™0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0) | Biological | Group 3 |
Primary outcome
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
Time frame: Day 7 - Day 196
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella and Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine in people with Measles and Mumps, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 22 Jan 2014. 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 Turkey (Türkiye). 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. (time frame: Day 7 - Day 196). 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 22 Jan 2014.