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VLA1553-403 Pregnancy Surveillance Study

ConditionChikungunya Virus Infection

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorValneva Austria GmbH

About this trial

This post-marketing, observational study evaluates pregnancy and infant outcomes up to 12 weeks after delivery among women who received the chikungunya vaccine (VLA1553) during pregnancy or within 30 days before their last menstrual period. A matched comparator cohort of pregnant women vaccinated with routine, pregnancy-recommended vaccines (not exposed to VLA1553) is included. No study procedures beyond routine care are performed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women who have received the single dose of the VLA1553 vaccine during pregnancy or within the 30 days prior to the first day of the last menstrual period.

Pregnant at the time of enrolment in the study.

The participant understands and agrees to comply with the study procedures.

Pregnant at the time of enrolment in the study.

Disqualifiers

Women who do not provide informed consent.

Women who are not part of the target population of the pilot vaccination strategy at the time of vaccination.

Trial population

The control group will consist of women who have received vaccine(s) approved for use during pregnancy by the MoH and who meet the matching criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Live-attenuated CHIKV vaccine VLA1553
Biological/Vaccine
Non-interventional study: VLA1553 is used in the pilot vaccination strategy which will start along with this observational study.
Vaccine(s) approved for use during pregnancy by the MoH
Biological/Vaccine
Vaccine(s) approved for use during pregnancy by the MoH

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: VLA1553 group1 intervention

Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Frequency (n,%) of individuals with any outcome (pregnancy and infant health), as described in the protocol.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

2

Frequency (n,%) of specific outcomes (pregnancy and infant health), as described in the protocol.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

Secondary outcomes

1

Frequency (n,%) of individuals with any outcome (pregnancy and infant health), as described in the protocol in the VLA1553 group and the control group.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

2

Frequency (n,%) of specific outcomes (pregnancy and infant health), as described in the protocol in the VLA1553 group and the control group.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

3

Relative risk (RR) of any outcome (pregnancy and infant health) between pregnant women vaccinated with VLA1553 and pregnant women vaccinated with other vaccines recommended during pregnancy, as described in the protocol.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

4

Frequency (n,%) of individuals with SAEs (women and infants), following vaccination with VLA1553 or a control vaccine.

Pregnancy and infant outcomes will be collected as follows: 1. Pregnancy outcomes: stillbirths, pregnancy terminations (spontaneous and elective), preterm deliveries, neonatal deaths and term live births. 2. Infant outcomes: births small for gestational age, major congenital malformations.

Time frame

Study start through study completion, an average of 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Valneva Austria GmbH

Lead sponsor

Butantan Foundation

Collaborator

Coalition for Epidemic Preparedness Innovations

Collaborator

Source ClinicalTrials.gov

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