PREGCOVAC-19: the follow up of pregnant women who received COVID-19 vaccination in the Dutch national vaccination program

Phase 1

• Conditions: Pregnant women aged = 18 years who are scheduled for COVID-19 vaccination within the Dutch national vaccination program with any of the currently or future available vaccines that are used for pregnant women in the Dutch national vaccination program.; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; MedDRA version: 21.1Level: LLTClassification code 10036586Term: PregnantSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002327-38-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-17
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

- competent pregnant women (18 = years)
- scheduled for COVID-19 vaccination

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-A potential subject who meets any of the following criteria will be excluded from participation in this study:
-No written informed consent
-Age < 18 years
-No knowledge of Dutch or English language

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.Evaluation of IgG antibody response in pregnant women after participation in the Dutch national COVID-19 vaccination program.<br>2.Evaluation of the relation between gestational age at vaccination and maternal antibody response and trans placental IgG antibody transfer.<br>3.Registration of obstetric outcomes. <br><br><br><br>;Secondary Objective: Not applicable;Primary end point(s): The description of the antibody response in maternal blood during pregnancy and the amount of placental transfer as determined in umbilical cord blood in relation to the gestational age at vaccination. ;Timepoint(s) of evaluation of this end point: There are multiple points throughout time in which bloodsampling will take place:<br>1. Before vaccination <br>2. Fifteen days after the first vaccination <br>3: Fifteen days after the second vaccination (if this is part of the Dutch national vaccination program)<br>4. At birth, at this point in time point cordblood will be taken as well<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -The number of neonates with an antibody response as reflected by IgG levels in cord blood. <br>-The trimester of pregnancy with the best balance between maternal IgG antibody response and trans placental IgG antibody transfer to the neonate.<br>-The obstetric outcome in relation to the trimester in which vaccination was performed.<br><br>;Timepoint(s) of evaluation of this end point: At birth