COVID-19: study to detect transfer of SARS-Cov-2 antibodies in breastmilk

COVID-19: study to detect transfer of SARS-Cov-2 antibodies in breastmilk - COVID-19: COVID-antilichamen in borstvoedingsmelk

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000893-27-BE

Enrollment

Registered

2021-03-04

Start date

2021-04-27

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

pregnancy lactating mothers

Interventions

Trade Name: Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - health care employees (or patients) - 18 years or older - voluntarily receiving vaccination - pregnant or lactating 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - not eligible according to the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: to verify if Sars-Cov-2 specific antibodies can be demonstrated in blood serum and milk of lactating mothers who were vaccinated;Secondary Objective: determination of COVID-antibodies in blood, milk and infant blood of mothers vaccinated during lactation;Primary end point(s): presence and amount of IGM and IgG or IgA antibodies;Timepoint(s) of evaluation of this end point: lactating women who were vaccinated blood sample - before vaccination - 4 weeks after first vaccin dose - 8 weeks after second vaccin dose breast milk - 4 weeks after first vaccin dose - 3 weeks after second vaccin dose pregnant women who were COVID-infected blood - at time of delivery milk - 6 weeks postdelivery	—

Measure

Time frame

Main Objective: to verify if Sars-Cov-2 specific antibodies can be demonstrated in blood serum and milk of lactating mothers who were vaccinated;Secondary Objective: determination of COVID-antibodies in blood, milk and infant blood of mothers vaccinated during lactation;Primary end point(s): presence and amount of IGM and IgG or IgA antibodies;Timepoint(s) of evaluation of this end point: lactating women who were vaccinated blood sample - before vaccination - 4 weeks after first vaccin dose - 8 weeks after second vaccin dose breast milk - 4 weeks after first vaccin dose - 3 weeks after second vaccin dose pregnant women who were COVID-infected blood - at time of delivery milk - 6 weeks postdelivery

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium

Contacts

Public ContactClinical Trial Center

AZ SInt-Jan Brugge-Oostende AV

ctc@azsintjan.be003250453289

Outcome results

None listed

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