COVID-19 Vaccine Adverse ReactionPEDIVACOV-HCSCNCT06646744
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
An observational study of COVID-19 Vaccine Adverse Reaction, run by Ana Belen Rivas Paterna at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine Adverse Reaction
- What is being tested?
- mRNA COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 2,100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2022to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All the pediatric patients (between 5-12 years old) vaccinated in the Clinico San Carlos' Hospital
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, 28040
About this study
Official title: Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)
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.
Read the detailed description
Drug-related side effects are an important health problem causing an increase in health costs. Most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. This situation remains true in the clinical trials of the mRNA vaccines against COVID-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Being tested
- mRNA COVID-19 vaccine
- Keywords
- COVID19 vaccine, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA COVID-19 vaccineBiological
Children will be vaccinated according to standard local procedure
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated children | Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19. Receives: Biological: mRNA COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vaccine side effects
Incidence of vaccine side effects
Measured: 10 days, 1 month and 6 months after vaccination
Secondary outcomes (7)
Vaccine side effects
Clinical description of side effects that occurre during follow up
Measured: 10 days, 1 month and 6 months after vaccination
Time to vaccine side effect
Clinical description of side effect according to the time of appearance
Measured: 10 days, 1 month and 6 months after vaccination
Causality of side effects
Evaluation of the causality by using the modified Karch-Lasagna modified scale
Measured: 10 days, 1 month and 6 months after vaccination
Severity of side effects
Evaluation of the severity using de Venulet criteria and the spanish pharmacovigilance system
Measured: 10 days, 1 month and 6 months after vaccination
Vaccine and drug interactions
Evaluation of the possible interaction between the vaccines and regularly prescribed drugs
Measured: 10 days, 1 month and 6 months after vaccination
Vaccine reactogenicity
Evaluation of the difference reactogenicity between the first and second vaccine dose by recording the side effect appearance after each dose.
Measured: 10 days, 1 month and 6 months after vaccination
Perceived quality of the vaccination system
Evaluation of the parents perceived quality of the vaccination system
Measured: 10 days, 1 month and 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start8 Mar 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Belen Rivas Paterna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Belen Rivas Paterna, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646744
- Sponsor's protocol ID
- PEDIVACOV-HCSC
- Acronym
- PEDIVACOV-HCSC
- Status last verified
- Jan 2024
- First submitted
- 15 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
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.
PubMed 34538306Belen 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.
PubMed 26819267Vargas 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.
PubMed 12626971Omer 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.
PubMed 34793741Luxi 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.
PubMed 34739716Yan 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.
PubMed 34696205Zheng 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.
PubMed 34618327
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)
- ClinicalTrials.gov ID
- NCT06646744
- Acronym / sponsor ID
- PEDIVACOV-HCSC / PEDIVACOV-HCSC
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Keywords
- COVID19 vaccine, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- Ana Belen Rivas PaternaUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Drug-related side effects are an important health problem causing an increase in health costs. Most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. This situation remains true in the clinical trials of the mRNA vaccines against COVID-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated children | – | Biological: mRNA COVID-19 vaccineChildren between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All the pediatric patients (between 5-12 years old) vaccinated in the Clinico San Carlos' Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA COVID-19 vaccineChildren will be vaccinated according to standard local procedure | Biological | Vaccinated children |
Primary outcome
Incidence of vaccine side effects
Time frame: 10 days, 1 month and 6 months after vaccination
Incidence of vaccine side effects
7 secondary outcomes
Vaccine side effects
Time frame: 10 days, 1 month and 6 months after vaccination
Time to vaccine side effect
Time frame: 10 days, 1 month and 6 months after vaccination
Causality of side effects
Time frame: 10 days, 1 month and 6 months after vaccination
Severity of side effects
Time frame: 10 days, 1 month and 6 months after vaccination
Vaccine and drug interactions
Time frame: 10 days, 1 month and 6 months after vaccination
Vaccine reactogenicity
Time frame: 10 days, 1 month and 6 months after vaccination
Perceived quality of the vaccination system
Time frame: 10 days, 1 month and 6 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 34538306Galindo 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.
- Background: PubMed 26819267Belen 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.
- Background: PubMed 12626971Vargas 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.
- Background: PubMed 34793741Omer 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.
- Background: PubMed 34739716Luxi 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.
- Background: PubMed 34696205Yan 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.
- Background: PubMed 34618327Zheng 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccine Adverse Reaction, run by Ana Belen Rivas Paterna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vaccine side effects (time frame: 10 days, 1 month and 6 months after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646744, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.