Impact of Maternal COVID-19 Vaccines on Breast Milk

NCT ID: NCT04751734

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-16

Study Completion Date

2023-12-31

Brief Summary

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prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.

Detailed Description

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Conditions

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COVID-19 Vaccines

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinations

SARS-CoV-2 vaccination

Covid vaccines

Intervention Type BIOLOGICAL

women within Priority groups for coronavirus (COVID-19) vaccination

Interventions

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Covid vaccines

women within Priority groups for coronavirus (COVID-19) vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines.

Exclusion Criteria

* cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital ClĂ­nico Universitario de Valencia

OTHER

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role collaborator

Hospital Universitario Doctor Peset

OTHER

Sponsor Role collaborator

Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role collaborator

Universitat Jaume I

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Institute of Agrochemistry and Food Technology, National Research Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maria Carmen Collado

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fundacion Investigacion Sanitaria INCLIVA

Valencia, , Spain

Site Status

Hospital Universitario y Politecnico la Fe

Valencia, , Spain

Site Status

Countries

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Spain

References

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Selma-Royo M, Bauerl C, Mena-Tudela D, Aguilar-Camprubi L, Perez-Cano FJ, Parra-Llorca A, Lerin C, Martinez-Costa C, Collado MC. Anti-SARS-CoV-2 IgA and IgG in human milk after vaccination is dependent on vaccine type and previous SARS-CoV-2 exposure: a longitudinal study. Genome Med. 2022 Apr 21;14(1):42. doi: 10.1186/s13073-022-01043-9.

Reference Type DERIVED
PMID: 35449030 (View on PubMed)

Other Identifiers

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IATA-CSIC

Identifier Type: -

Identifier Source: org_study_id

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