PregnancyImmRubVacNCT02934295
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
A study testing Determination of Anti-Rubella Antibody, E1 in people with Pregnancy, run by Hopital Foch at 2 sites in France.
Trial summary
The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Determination of Anti-Rubella Antibody, E1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to Oct 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18
- Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
- Accepting the rubella vaccination after the childbirth;
- Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
- Affiliated to a social security scheme
- Having given a written consent
Who cannot join
- Rubella contracted since the first serology realized during the first prenatal consultation
- Autoimmune pathologies
- Intolerance / allergy known about a previous vaccination whatever it is
- Immunosuppression (HIV, transplants)
- Injection of multivalent immunoglobulins (except anti-D)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Antoine-Béclère
Clamart, 92140
Hôpital Foch
Suresnes, 92150
About this study
The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.
- Conditions
- Pregnancy
- Being tested
- Determination of Anti-Rubella Antibody, E1
- Keywords
- Rubeola
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of Anti-Rubella Antibody, E1Biological
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Not described Receives: Biological: Determination of Anti-Rubella Antibody, E1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Anti-Rubella Antibody, E1
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Picone, Principal investigator, Hôpital FochChristelle VAULOUP-FELLOUS, MD, Study chair, Hôpital Brousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934295
- Sponsor's protocol ID
- 2011/61
- Other IDs
- 2011-A01445-36
- Acronym
- ImmRubVac
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
- ClinicalTrials.gov ID
- NCT02934295
- Acronym / sponsor ID
- ImmRubVac / 2011/61
- Conditions
- Pregnancy
- Keywords
- Rubeola
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 2016 (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 aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Biological: Determination of Anti-Rubella Antibody, E1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women over 18
- Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
- Accepting the rubella vaccination after the childbirth;
- Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
- Affiliated to a social security scheme
Key exclusion criteria (5 listed)
- Rubella contracted since the first serology realized during the first prenatal consultation
- Autoimmune pathologies
- Intolerance / allergy known about a previous vaccination whatever it is
- Immunosuppression (HIV, transplants)
- Injection of multivalent immunoglobulins (except anti-D)
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 |
|---|---|---|
| Determination of Anti-Rubella Antibody, E1 | Biological | Pregnant women |
Primary outcome
Level of Anti-Rubella Antibody, E1
Time frame: 8 months
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 1 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Olivier Picone principal investigator
Hôpital Foch
Christelle VAULOUP-FELLOUS, MD study chair
Hôpital Brousse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of Anti-Rubella Antibody, E1 in people with Pregnancy, run by Hopital Foch at 2 sites in France.
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 5 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
Level of Anti-Rubella Antibody, E1 (time frame: 8 months). 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 1 Feb 2017.