NCT04751734

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 8, 2021

Last Update Submit

March 15, 2024

Conditions

COVID-19 Vaccines

Keywords

breast milkmicrobiotametabolitesimmune compoundsgrowth and development

Outcome Measures

Primary Outcomes (1)

  • Antibodies

    presence and levels of antibodies

    1st year

Secondary Outcomes (5)

  • breast milk bioactive composition

    1st year

  • breast milk bioactive composition

    1st year

  • breast milk bioactive composition

    1st year

  • infant microbiota

    1st year

  • infant growth and development

    1st year

Study Arms (1)

Vaccinations

SARS-CoV-2 vaccination

Biological: Covid vaccines

Interventions

Covid vaccinesBIOLOGICAL

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

Vaccinations

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women is Spain

You may qualify if:

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

You may not qualify if:

  • cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundacion Investigacion Sanitaria INCLIVA

Valencia, Spain

Location

Hospital Universitario y Politecnico la Fe

Valencia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35449030DERIVED

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 12, 2021

Study Start

January 16, 2021

Primary Completion

January 31, 2023

Study Completion

December 31, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)