Trial Outcomes & Findings for Safety of 4CMenB Exposure During Pregnancy (NCT NCT02640677)

Results Overview

Recruitment status

COMPLETED

Target enrollment

2 participants

Primary outcome timeframe

At registry enrollment

Results posted on

2020-09-03

Participant Flow

At the end of recruitment of this pregnancy registry for Bexsero, there were only 2 registrations. Of these,1 subject withdrew the consent and the other subject did not return for a follow up, hence considered as lost to follow up. Therefore, no pregnancy outcome data are available for this study.

Participant milestones

Participant milestones
Measure	Pregnant Women Exposed to 4CMenB Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregnant Women Exposed to 4CMenB Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety of 4CMenB Exposure During Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women Exposed to 4CMenB n=2 Participants Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic ethinicity	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At registry enrollment

Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At registry enrollment

Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At registry enrollment

Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At registry enrollment

Population: Data was not collected as the enrolled participants did not complete the study

Outcome measures

Outcome data not reported

Adverse Events

Pregnant Women Exposed to 4CMenB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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 trial.
Publication restrictions are in place

Restriction type: OTHER