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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002327-38-NL

Enrollment

100

Registered

2021-05-17

Start date

2021-05-26

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865 MedDRA version: 21.1 Level: LLT Classification code 10036586 Term: Pregnant System Organ Class: 100000004868

Interventions

Trade Name: Comirnaty Product Name: Comirnaty Product Code: EMEA/H/C/005735 Pharmaceutical Form: Injection INN or Proposed INN: Tozinameran CAS Number: 2417899-77-3 Current Sponsor code: BNT162b2 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Evaluation of IgG antibody response in pregnant women after participation in the Dutch national COVID-19 vaccination program. 2. Evaluation of the relation between gestational age at vaccination and maternal antibody response and trans placental IgG antibody transfer. 3. Registration of obstetric outcomes. ;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: 1. Before vaccination 2. Fifteen days after the first vaccination 3: Fifteen days after the second vaccination (if this is part of the Dutch national vaccination program) 4. At birth, at this point in time point cordblood will be taken as well	—

Measure

Time frame

Main Objective: 1. Evaluation of IgG antibody response in pregnant women after participation in the Dutch national COVID-19 vaccination program. 2. Evaluation of the relation between gestational age at vaccination and maternal antibody response and trans placental IgG antibody transfer. 3. Registration of obstetric outcomes. ;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: 1. Before vaccination 2. Fifteen days after the first vaccination 3: Fifteen days after the second vaccination (if this is part of the Dutch national vaccination program) 4. At birth, at this point in time point cordblood will be taken as well

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactE. van Leeuwen

Academic Medical Center

onderzoeksbureauvkc@amsterdamumc.nl0031205669111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026