Last updated: 04/01/2020 11:50:06

Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry

GSK study ID
205531
See study documents
Clinicaltrials.gov ID
NCT02223637
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: MENVEO pregnancy registry: an observational study on the safety of MENVEO exposure in pregnant women and their offspring
Trial description: The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine.
It is an observational study of women inadvertently immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care.
The objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of live births reported with major congenital malformations (MCM) on exposure to Menveo within 28 days prior to conception

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. From registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)

Percentage of live births reported with major congenital malformations (MCM) on exposure to Menveo vaccine during the first trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)

Percentage of live births reported with major congenital malformations (MCM) on exposure to Menveo vaccine during the second trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)

Percentage of live births reported with major congenital malformations (MCM) on exposure to Menveo vaccine during third trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during third trimester of pregnancy [>27 weeks] until the estimated delivery date)

Percentage of live births reported with major congenital malformations (MCM) on exposure to Menveo within 28 days prior to conception or at any time during the pregnancy

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)

Percentage of preterm births reported on exposure to Menveo vaccine within 28 days prior to conception

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)

Percentage of preterm births reported on exposure to Menveo vaccine during the first trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)

Percentage of preterm births reported on exposure to Menveo vaccine during the second trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)

Percentage of preterm births reported on exposure to Menveo vaccine during the third trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)

Percentage of preterm births reported on exposure to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)

Percentage of low birth weight (LBW) live births reported on exposure to Menveo vaccine vaccine within 28 days prior to conception

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)

Percentage of LBW live births reported on exposure to Menveo vaccine during the first trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)

Percentage of LBW live births reported on exposure to Menveo vaccine during the second trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)

Percentage of LBW live births reported on exposure to Menveo vaccine during the third trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)

Percentage of LBW live births reported on exposure to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)

Secondary outcomes:

Number of pregnancy outcomes reported for subjects exposed to Menveo within 28 days prior to conception

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)

Number of pregnancy outcomes reported for subjects exposed to Menveo during the first trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)

Number of pregnancy outcomes reported for subjects exposed to Menveo vaccine during the second trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)

Number of pregnancy outcomes reported for subjects exposed to Menveo vaccine during the third trimester

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)

Number of pregnancy outcomes reported for subjects exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy

Timeframe: From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)

Interventions:
  • Biological/vaccine: Meningococcal quadrivalent CRM-197 conjugate vaccine
    • Enrollment:
    93
    Primary completion date:
    2017-08-12
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Tracy A Becerra-Culqui, Lina S. Sy, Bradley K Ackerson, Lie Hong Chen, Christine A. Fischetti, Zendi Solano, Johannes E Schmidt, Lucio Malvisi, Carlo Curina, Michele Pellegrini, Hung Fu Tseng. Safety of MenACWY-CRM vaccine exposure during pregnancy. Vaccine. 2020. 38(12):2683-2690.
    Medical condition
    Meningococcal disease, Pregnancy
    Product
    GSK3536820A
    Collaborators
    Not applicable
    Study date(s)
    September 2014 to December 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to conception or at any time during pregnancy
    • Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to conception or at any time during pregnancy
    • Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
    • Date the pregnancy exposure is registered
    • Full reporter (ie, HCP) contact information to allow for follow-up (name, address, etc.)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401-3331
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-08-12
    Actual study completion date
    2017-08-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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