Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19

NCT ID: NCT04355533

Last Updated: 2026-01-06

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

Clinical Phase

NA

Total Enrollment

1056 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-05-24

Brief Summary

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The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

Detailed Description

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The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

Conditions

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COVID-19 Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hospitalized children or consulting at hospital

Group Type EXPERIMENTAL

serology test

Intervention Type BIOLOGICAL

volume according to child weight

nasopharyngeal swab

Intervention Type BIOLOGICAL

nasopharyngeal swab for PCR

rectal swab

Intervention Type BIOLOGICAL

rectal swab for PCR

saliva sample

Intervention Type BIOLOGICAL

for biocollection

Parents of one included child

Group Type EXPERIMENTAL

serology test

Intervention Type BIOLOGICAL

volume according to child weight

nasopharyngeal swab

Intervention Type BIOLOGICAL

nasopharyngeal swab for PCR

saliva sample

Intervention Type BIOLOGICAL

for biocollection

Children with potential COVID disease during the first wave

Group Type EXPERIMENTAL

serology test

Intervention Type BIOLOGICAL

volume according to child weight

nasopharyngeal swab

Intervention Type BIOLOGICAL

nasopharyngeal swab for PCR

rectal swab

Intervention Type BIOLOGICAL

rectal swab for PCR

saliva sample

Intervention Type BIOLOGICAL

for biocollection

Children SARS-coV2 positive

Group Type EXPERIMENTAL

serology test

Intervention Type BIOLOGICAL

volume according to child weight

nasopharyngeal swab

Intervention Type BIOLOGICAL

nasopharyngeal swab for PCR

rectal swab

Intervention Type BIOLOGICAL

rectal swab for PCR

saliva sample

Intervention Type BIOLOGICAL

for biocollection

Person living under the same roof as children included in the study

Group Type EXPERIMENTAL

serology test

Intervention Type BIOLOGICAL

volume according to child weight

nasopharyngeal swab

Intervention Type BIOLOGICAL

nasopharyngeal swab for PCR

rectal swab

Intervention Type BIOLOGICAL

rectal swab for PCR

saliva sample

Intervention Type BIOLOGICAL

for biocollection

Interventions

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serology test

volume according to child weight

Intervention Type BIOLOGICAL

nasopharyngeal swab

nasopharyngeal swab for PCR

Intervention Type BIOLOGICAL

rectal swab

rectal swab for PCR

Intervention Type BIOLOGICAL

saliva sample

for biocollection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

For hospitalized children or consulting at hospital

* any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
* Parent's agreement for blood, saliva and stool samples
* Optional parent's agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children with potential COVID disease during the first wave

* Any child over 7 days old and under 17 years, seropositive during the first wave
* Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
* With an Health insurance

Parent of the enrolled child

* One parent of the enrolled child on ped-covid
* Agreement for blood and saliva samples
* Optional agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children SARS-coV2 positive

* any child less then 18 years old
* infected by SARS-coV2
* Parent's agreement for blood, saliva samples
* Optional parent's agreement for nasopharynx swab
* With health insurance

For people living under the same roof of a child included in the study

* any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
* With health insurance

Exclusion Criteria

For hospitalized children or consulting at hospital

* child younger than 7 days
* Refusal of parent
* Refusal of child
* No health insurance
Minimum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle SERMET-GAUDELUS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Pars

Locations

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Hôpital necker Enfants-Malades

Paris, , France

Site Status

Countries

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France

References

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Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12.

Reference Type RESULT
PMID: 36065993 (View on PubMed)

Other Identifiers

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2020-A00999-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP200467

Identifier Type: -

Identifier Source: org_study_id

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