Infections, MeningococcalNCT02640677
Safety of 4CMenB Exposure During Pregnancy
An observational study of Infections, Meningococcal, run by GlaxoSmithKline at 1 site in United States.
Trial summary
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- 4CMenB
- Type of treatment
- Vaccines
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2016to 30 Nov 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy.
Who may be able to join
- Any pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy where:
- Sufficient evidence to confirm that exposure to a meningococcal B vaccine (confirmed or possible 4CMenB exposure) occurred within 30 days prior to LMP or at any time during pregnancy
- Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
- Date the pregnancy exposure is registered
- Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)
Who cannot join
- Pregnant women vaccinated with a different brand of Meningococcal B vaccine will not be included. (Of note: In the event that it cannot be ascertained to which meningococcal B vaccine the woman was exposed, an unknown exposure cohort will be established and analyzed separately).
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Wilmington, North Carolina, 28401-3331
About this study
Official title: 4CMenB Pregnancy Registry: an Observational Study of the Safety of 4CMenB Exposure in Pregnant Women and Their Offspring.
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy.
- Conditions
- Infections, Meningococcal
- Being tested
- 4CMenB
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4CMenBBiological
This study is strictly observational; Administration of BEXSERO, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women exposed to 4CMenB | Pregnant women within the United States (U.S) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy Receives: Biological: 4CMenB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Congenital Malformation (MCM)
Measured: At registry enrollment
Preterm Birth
Measured: At registry enrollment
Low Birth Weight (LBW)
Measured: At registry enrollment
Secondary outcomes (1)
Spontaneous Abortions and Still Births
Measured: At registry enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start31 Jan 2016
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640677
- Sponsor's protocol ID
- 205533
- Other IDs
- V72_82OB, EUPAS 12183
- Status last verified
- Sep 2020
- First submitted
- 21 Dec 2015
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4CMenB Pregnancy Registry: an Observational Study of the Safety of 4CMenB Exposure in Pregnant Women and Their Offspring.
- ClinicalTrials.gov ID
- NCT02640677
- Acronym / sponsor ID
- 205533
- Conditions
- Infections, Meningococcal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women exposed to 4CMenB | – | Biological: 4CMenBPregnant women within the United States (U.S) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy.
Key inclusion criteria (5 listed)
- Any pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy where:
- Sufficient evidence to confirm that exposure to a meningococcal B vaccine (confirmed or possible 4CMenB exposure) occurred within 30 days prior to LMP or at any time during pregnancy
- Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
- Date the pregnancy exposure is registered
- Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)
Key exclusion criteria (1 listed)
- Pregnant women vaccinated with a different brand of Meningococcal B vaccine will not be included. (Of note: In the event that it cannot be ascertained to which meningococcal B vaccine the woman was exposed, an unknown exposure cohort will be established and analyzed separately).
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 |
|---|---|---|
| 4CMenBThis study is strictly observational; Administration of BEXSERO, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care. | Biological | Pregnant women exposed to 4CMenB |
Primary outcome
Major Congenital Malformation (MCM)
Time frame: At registry enrollment
Preterm Birth
Time frame: At registry enrollment
Low Birth Weight (LBW)
Time frame: At registry enrollment
1 secondary outcome
Spontaneous Abortions and Still Births
Time frame: At registry enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Meningococcal, run by GlaxoSmithKline at 1 site in United States.
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 5 inclusion and 1 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 3 Sep 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Congenital Malformation (MCM) (time frame: At registry enrollment). The study lists 3 primary outcomes in all. 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 3 Sep 2020.