COVID-19 Vaccine
Conditions
Brief summary
There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.
Detailed description
The Pfizer-Biontec BNT162b2 vaccine has proven efficacy and safety for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older. Efficacy and safety were recently shown also for children aged 5-11 years. Side-effects are common, including some rare but important side-effects such as myocarditis. Myocarditis post Pfizer-Biontec BNT162b2 vaccination was described mostly among male adolescents and young adults. There are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years. This is a prospective cohort study assessing the immunogenicity of the BNT162b2 COVID-19 vaccine in children. The study population will be composed of children aged 5-11 years at the Schneider Children's Medical Center, with no contraindication for COVID-19 vaccination. Upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained. The study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. The study will last 6 months from the date of the approval of the study protocol. Blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. Samples will be tested for antibodies to SARS-CoV-2 at the Microbiology Laboratory at the Rabin Medical Center. Symptomatic participants with any respiratory symptoms or other symptoms suggestive of COVID-19 disease will be tested for SARS-CoV-2 by RT-PCR, at laboratories certified by the Ministry of Health.
Interventions
None listed
Sponsors
Rabin Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
Age 5-11 years
Exclusion criteria
Administration of COVID-19 vaccine\>21 days prior to enrollment, Contraindication for COVID-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients Congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of the Pfizer-Biontec BNT162b2 COVID-19 vaccine in children aged 5-11 years. Our second aim is to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children | Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) | SARS-CoV-2 serum antibody levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the long-term immune response following the BNT162b2 vaccine by SARS-CoV-2 serum antibody levels that meet or exceed the threshold of protection From COVID-19 | Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)]. | long-term immune response |
| Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels | Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) | Seroresponse rate |
| local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years | Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) | Description of side effects |
| Number of participants with serious adverse events (SAEs) | Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection) | erious adverse events (SAEs) |
| Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C) | Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection) | Adverse Events of Special Interest (AESIs) |
| Number of participants with medically-attended AEs (MAAEs) | Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection) | medically-attended AEs |
Countries
Israel
Outcome results
None listed