Trial Outcomes & Findings for Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry (NCT NCT02223637)
NCT ID: NCT02223637
Last Updated: 2019-06-21
Results Overview
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
COMPLETED
93 participants
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)
2019-06-21
Participant Flow
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)
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Baseline characteristics by cohort
| Measure |
Exposure Group
n=82 Participants
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.
|
|---|---|
|
Age, Continuous
|
18.9 Months
STANDARD_DEVIATION 1.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - White or Caucasian
|
14 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - Black or African American
|
12 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - Asian
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - Native Hawaiian or Other Pacific Islander
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - Other
|
52 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race - Unknown
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
|
57 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Not Hispanic or Latino
|
23 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Unknown
|
2 Participants
n=39 Participants
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
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
Outcome measures
| Measure |
Live Births Group
n=13 Participants
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
|
|---|---|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
Live births with MCM
|
0.0 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
Live births without MCM
|
84.6 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception
Live births with no known defects
|
15.4 Percentage of Live Births with MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=39 Participants
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
|
|---|---|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester
Live births with MCM
|
2.6 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester
Live births without MCM
|
87.2 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester
Live births with no known defects
|
10.3 Percentage of Live Births with MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine during second trimester of pregnancy
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
Outcome measures
| Measure |
Live Births Group
n=2 Participants
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
|
|---|---|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester
Live births with MCM
|
50.0 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester
Live births without MCM
|
50.0 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester
Live births with no known defects
|
0.0 Percentage of Live Births with MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine during third trimester of pregnancy
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
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester
Live births with MCM
|
0.0 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester
Live births without MCM
|
100.0 Percentage of Live Births with MCM
|
|
Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester
Live births with no known defects
|
0.0 Percentage of Live Births with MCM
|
PRIMARY outcome
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)Population: 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
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
Outcome measures
| Measure |
Live Births Group
n=55 Participants
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
|
|---|---|
|
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
Live births with MCM
|
3.6 Percentage of Live Births with MCM
|
|
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
Live births without MCM
|
85.5 Percentage of Live Births with MCM
|
|
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
Live births with no known defects
|
10.9 Percentage of Live Births with MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
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.
Outcome measures
| Measure |
Live Births Group
n=13 Participants
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
|
|---|---|
|
Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception
|
23.1 Percentage of preterm births without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the first trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=38 Participants
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
|
|---|---|
|
Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester
|
10.5 Percentage of preterm births without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester
|
100.0 Percentage of preterm births without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester
|
0.0 Percentage of preterm births without MCM
|
PRIMARY outcome
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)Population: 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
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.
Outcome measures
| Measure |
Live Births Group
n=53 Participants
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
|
|---|---|
|
Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
|
15.1 Percentage of preterm births without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception
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.
Outcome measures
| Measure |
Live Births Group
n=13 Participants
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
|
|---|---|
|
Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception
|
15.4 Percentage of LBW live birth without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=38 Participants
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
|
|---|---|
|
Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester
|
5.3 Percentage of LBW live birth without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester
|
100.0 Percentage of LBW live birth without MCM
|
PRIMARY outcome
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)Population: The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy
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.
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester
|
0.0 Percentage of LBW live birth without MCM
|
PRIMARY outcome
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)Population: 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
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.
Outcome measures
| Measure |
Live Births Group
n=53 Participants
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
|
|---|---|
|
Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
|
9.4 Percentage of LBW live birth without MCM
|
SECONDARY outcome
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)Population: The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to conception
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.
Outcome measures
| Measure |
Live Births Group
n=16 Participants
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
|
|---|---|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Live Births
|
12 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Stillbirth
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
SAB
|
2 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
IAB
|
2 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Ectopic pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Molar pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception
Others
|
0 Pregnancy outcomes
|
SECONDARY outcome
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)Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the first trimester of pregnancy
The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others.
Outcome measures
| Measure |
Live Births Group
n=59 Participants
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
|
|---|---|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Live Births
|
39 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Stillbirths
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
SAB
|
7 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
IAB
|
13 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Ectopic pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Molar pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester
Others
|
0 Pregnancy outcomes
|
SECONDARY outcome
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)Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the second trimester of pregnancy
The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others
Outcome measures
| Measure |
Live Births Group
n=2 Participants
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
|
|---|---|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Live Births
|
2 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Stillbirths
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
SAB
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
IAB
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Ectopic pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Molar pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester
Others
|
0 Pregnancy outcomes
|
SECONDARY outcome
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)Population: The analysis was performed on subjects who were exposed to Menveo vaccine during the third trimester of pregnancy
The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others.
Outcome measures
| Measure |
Live Births Group
n=1 Participants
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
|
|---|---|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Others
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Live Births
|
1 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Stillbirths
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
SAB
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
IAB
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Ectopic pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester
Molar pregnancy
|
0 Pregnancy outcomes
|
SECONDARY outcome
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)Population: 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.
The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others.
Outcome measures
| Measure |
Live Births Group
n=82 Participants
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
|
|---|---|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Others
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Live Births
|
54 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Stillbirths
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
SAB
|
10 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
IAB
|
18 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Ectopic pregnancy
|
0 Pregnancy outcomes
|
|
Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy
Molar pregnancy
|
0 Pregnancy outcomes
|
Adverse Events
Exposure Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER