Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02223637
• Collaborator: (none)
• Enrollment: 93
• Locations: 2
• Actual Duration (Months): 38.3
• Patients Per Site: 46.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Disease; Pregnancy; Infections, Meningococcal	Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 93 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MENVEO Pregnancy Registry: an Observational Study on the Safety of MENVEO Exposure in Pregnant Women and Their Offspring
• Actual Study Start Date: Sep 30, 2014
• Actual Primary Completion Date: Dec 8, 2017
• Actual Study Completion Date: Dec 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Exposure group Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.	Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine; This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.

Outcome Measures

Primary Outcome Measures

1. Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception [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)]

   The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births

2. Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester [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)]

   The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the first trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births.

3. Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester [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)]

   The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the second trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births

4. Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester [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)]

   The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the third trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births

5. 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 [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)]

   The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births

6. Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception [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)]

   A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.

7. Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester [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)]

   A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.

8. Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester [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)]

   A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.

9. Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester [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)]

   A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.

10. Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy [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)]

    A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.

11. Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception [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)]

    A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.

12. Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester [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)]

    A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.

13. Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester [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)]

    A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.

14. Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester [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)]

    A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.

15. Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy [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)]

    A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.

Secondary Outcome Measures

1. Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception [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)]

   The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. Spontaneous abortions (SABs) are defined as fetal death or expulsion of products of conception prior to 20 weeks gestation. Induced abortions (IABs) are defined as voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities. Stillbirths are defined as fetal death occurring at 20 weeks gestation or greater, or if gestation age is unknown, a fetus weighing 500 g or more. Ectopic pregnancy is defined as implantation of a conception outside of the uterus. Molar pregnancy is defined as a conception that results in a gestational trophoblastic tumor.

2. Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester [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)]

   The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others.

3. Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester [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)]

   The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others

4. Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester [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)]

   The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others.

5. Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy [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)]

   The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.)

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Wilmington	North Carolina	United States	28401-3331
2	GSK Investigational Site	Wilmington	North Carolina	United States	28401-

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Sep 1, 2014
• Statistical Analysis Plan - Aug 11, 2016

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02223637
• Other Study ID Numbers: 205531; V59_72OB
• First Posted: Aug 22, 2014
• Last Update Posted: Jun 21, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Meningococcal Infections

Study Results

Participant Flow

Pre-assignment Detail	Of the 93 subjects included in the registry,82 subjects were included for analysis as 7 lost to follow up & 4 were invalid cases. Of these 82 subjects,1 pregnancy resulted in 1 set of twins birth.Analyses on outcome measures were performed on pregnant outcomes(Analysis population pregnancy outcomes)& on live births(Analysis population live births)

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Period Title: Overall Study
STARTED	82
COMPLETED	82
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Overall Participants	82
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	18.9 (1.7)
Sex: Female, Male (Count of Participants)
Female	82 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Race - White or Caucasian	14 17.1%
Race - Black or African American	12 14.6%
Race - Asian	1 1.2%
Race - Native Hawaiian or Other Pacific Islander	2 2.4%
Race - Other	52 63.4%
Race - Unknown	1 1.2%
Ethnicity - Hispanic or Latino	57 69.5%
Ethnicity - Not Hispanic or Latino	23 28%
Ethnicity - Unknown	2 2.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
Description	The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	13
Live births with MCM	0.0
Live births without MCM	84.6
Live births with no known defects	15.4

2. Primary Outcome

Title	Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester
Description	The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the first trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	39
Live births with MCM	2.6
Live births without MCM	87.2
Live births with no known defects	10.3

3. Primary Outcome

Title	Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester
Description	The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the second trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine during second trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	2
Live births with MCM	50.0
Live births without MCM	50.0
Live births with no known defects	0.0

4. Primary Outcome

Title	Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester
Description	The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the third trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine during third trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	1
Live births with MCM	0.0
Live births without MCM	100.0
Live births with no known defects	0.0

5. Primary Outcome

Title	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
Description	The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	55
Live births with MCM	3.6
Live births without MCM	85.5
Live births with no known defects	10.9

6. Primary Outcome

Title	Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception
Description	A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	13
Number [Percentage of preterm births without MCM]	23.1

7. Primary Outcome

Title	Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester
Description	A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine during the first trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	38
Number [Percentage of preterm births without MCM]	10.5

8. Primary Outcome

Title	Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester
Description	A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	1
Number [Percentage of preterm births without MCM]	100.0

9. Primary Outcome

Title	Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester
Description	A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	1
Number [Percentage of preterm births without MCM]	0.0

10. Primary Outcome

Title	Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Description	A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	53
Number [Percentage of preterm births without MCM]	15.1

11. Primary Outcome

Title	Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception
Description	A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	13
Number [Percentage of LBW live birth without MCM]	15.4

12. Primary Outcome

Title	Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester
Description	A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	38
Number [Percentage of LBW live birth without MCM]	5.3

13. Primary Outcome

Title	Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester
Description	A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	1
Number [Percentage of LBW live birth without MCM]	100.0

14. Primary Outcome

Title	Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester
Description	A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	1
Number [Percentage of LBW live birth without MCM]	0.0

15. Secondary Outcome

Title	Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Description	The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others. Spontaneous abortions (SABs) are defined as fetal death or expulsion of products of conception prior to 20 weeks gestation. Induced abortions (IABs) are defined as voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities. Stillbirths are defined as fetal death occurring at 20 weeks gestation or greater, or if gestation age is unknown, a fetus weighing 500 g or more. Ectopic pregnancy is defined as implantation of a conception outside of the uterus. Molar pregnancy is defined as a conception that results in a gestational trophoblastic tumor.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to conception

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Measure Participants	16
Live Births	12
Stillbirth	0
SAB	2
IAB	2
Ectopic pregnancy	0
Molar pregnancy	0
Others	0

16. Secondary Outcome

Title	Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Description	The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on subjects who were exposed to Menveo vaccine during the first trimester of pregnancy

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Measure Participants	59
Live Births	39
Stillbirths	0
SAB	7
IAB	13
Ectopic pregnancy	0
Molar pregnancy	0
Others	0

17. Secondary Outcome

Title	Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Description	The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on subjects who were exposed to Menveo vaccine during the second trimester of pregnancy

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Measure Participants	2
Live Births	2
Stillbirths	0
SAB	0
IAB	0
Ectopic pregnancy	0
Molar pregnancy	0
Others	0

18. Secondary Outcome

Title	Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Description	The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on subjects who were exposed to Menveo vaccine during the third trimester of pregnancy

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Measure Participants	1
Live Births	1
Stillbirths	0
SAB	0
IAB	0
Ectopic pregnancy	0
Molar pregnancy	0
Others	0

19. Secondary Outcome

Title	Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Description	The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to pregnancy or at any time during the pregnancy.

Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
Measure Participants	82
Live Births	54
Stillbirths	0
SAB	10
IAB	18
Ectopic pregnancy	0
Molar pregnancy	0
Others	0

20. Primary Outcome

Title	Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Description	A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy

Arm/Group Title	Live Births Group
Arm/Group Description	All live births (single or multiple) who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy
Measure Participants	53
Number [Percentage of LBW live birth without MCM]	9.4

Adverse Events

Time Frame	No adverse events data was collected in this study.
Adverse Event Reporting Description	No adverse events data was collected in this study.
Arm/Group Title	Exposure Group
Arm/Group Description	Pregnant women who were exposed to ≥1 dose of Menveo vaccine within 28 days prior to conception or at any time during pregnancy were included.
All Cause Mortality
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trials.