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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2017-08-12
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
Finalized
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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