Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)

NCT06646744 | Completed

• 1 other identifier: PEDIVACOV-HCSC
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic. Although clinical trials have shown that vaccines are safe in the general population, specific real-life monitoring is needed to address the special situation that applies to children.

Conditions

COVID-19 Vaccine Adverse Reaction

Keywords

COVID19 vaccine; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions

Outcome Measures

Primary Outcomes (1)

• Incidence of vaccine side effects

  Incidence of vaccine side effects

  10 days, 1 month and 6 months after vaccination

Secondary Outcomes (7)

• Vaccine side effects

  10 days, 1 month and 6 months after vaccination

• Time to vaccine side effect

  10 days, 1 month and 6 months after vaccination

• Causality of side effects

  10 days, 1 month and 6 months after vaccination

• Severity of side effects

  10 days, 1 month and 6 months after vaccination

• Vaccine and drug interactions

  10 days, 1 month and 6 months after vaccination

Study Arms (1)

Vaccinated children

Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19.

Biological: mRNA COVID-19 vaccine

Interventions

mRNA COVID-19 vaccine BIOLOGICAL

Children will be vaccinated according to standard local procedure

Vaccinated children

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All the pediatric patients (between 5-12 years old) vaccinated in the Clinico San Carlos' Hospital

You may qualify if:

• Patients of both sexes between 5 and 12 years old.
• Pediatric patients with data included in the Clinico San Carlos' Hospital available for consultation.
• Acceptance by the parents/legal guardians for the participation and follow up.

You may not qualify if:

• None

Sponsors & Collaborators

• Ana Belen Rivas Paterna: lead

Study Sites (1)

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (7)

• Galindo R, Chow H, Rongkavilit C. COVID-19 in Children: Clinical Manifestations and Pharmacologic Interventions Including Vaccine Trials. Pediatr Clin North Am. 2021 Oct;68(5):961-976. doi: 10.1016/j.pcl.2021.05.004. Epub 2021 May 18.

  PMID: 34538306 BACKGROUND

• Belen Rivas A, Arruza L, Pacheco E, Portoles A, Diz J, Vargas E. Adverse drug reactions in neonates: a prospective study. Arch Dis Child. 2016 Apr;101(4):371-6. doi: 10.1136/archdischild-2015-309396. Epub 2016 Jan 27.

  PMID: 26819267 BACKGROUND

• Vargas E, Terleira A, Hernando F, Perez E, Cordon C, Moreno A, Portoles A. Effect of adverse drug reactions on length of stay in surgical intensive care units. Crit Care Med. 2003 Mar;31(3):694-8. doi: 10.1097/01.CCM.0000049947.80131.ED.

  PMID: 12626971 BACKGROUND

• Omer SB, Benjamin RM, Brewer NT, Buttenheim AM, Callaghan T, Caplan A, Carpiano RM, Clinton C, DiResta R, Elharake JA, Flowers LC, Galvani AP, Lakshmanan R, Maldonado YA, McFadden SM, Mello MM, Opel DJ, Reiss DR, Salmon DA, Schwartz JL, Sharfstein JM, Hotez PJ. Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA. Lancet. 2021 Dec 11;398(10317):2186-2192. doi: 10.1016/S0140-6736(21)02507-1. Epub 2021 Nov 15.

  PMID: 34793741 BACKGROUND

• Luxi N, Giovanazzi A, Capuano A, Crisafulli S, Cutroneo PM, Fantini MP, Ferrajolo C, Moretti U, Poluzzi E, Raschi E, Ravaldi C, Reno C, Tuccori M, Vannacci A, Zanoni G, Trifiro G; Ilmiovaccino COVID19 collaborating group. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety. Drug Saf. 2021 Dec;44(12):1247-1269. doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.

  PMID: 34739716 BACKGROUND

• Yan Z, Yang M, Lai CL. COVID-19 Vaccinations: A Comprehensive Review of Their Safety and Efficacy in Special Populations. Vaccines (Basel). 2021 Sep 28;9(10):1097. doi: 10.3390/vaccines9101097.

  PMID: 34696205 BACKGROUND

• Zheng YJ, Wang XC, Feng LZ, Xie ZD, Jiang Y, Lu G, Li XW, Jiang RM, Deng JK, Liu M, Xu BP, Wei Z, Liu G, Lu XX, Jin RM, Liu ZS, Shang YX, Shu SN, Bai Y, Lu M, Liu GH, Luo WJ, Cui YX, Ye LP, Lin LK, Zhao DC, Shen AD, Shao JB, Xiong LJ, Gao LW, Wang TY; China National Clinical Research Center for Respiratory Diseases; National Center for Children's Health, Beijing, China; Group of Respirology, Chinese Pediatric Society, Chinese Medical Association; Chinese Medical Doctor Association Committee on Respirology Pediatrics; China Medicine Education Association Committee on Pediatrics; Chinese Research Hospital Association Committee on Pediatrics; Chinese Non-government Medical Institutions Association Committee on Pediatrics; China Association of Traditional Chinese Medicine, Committee on Children's Health and Medicine Research; Zhao ZY, Yang YH, Shen KL. Expert consensus on COVID-19 vaccination in children. World J Pediatr. 2021 Oct;17(5):449-457. doi: 10.1007/s12519-021-00465-6. Epub 2021 Oct 7. No abstract available.

  PMID: 34618327 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: designed by Principal Investigator

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: March 8, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)