SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19

NCT05175989 | Unknown

• 1 other identifier: 0810-21-RMC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  SARS-CoV-2 serum antibody levels

  Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)

Secondary Outcomes (6)

• 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)

• 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)].

• 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)

• Number of participants with medically-attended AEs (MAAEs)

  Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)

• Number of participants with serious adverse events (SAEs)

  Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 5-11 years eligible for BNT162b2 vaccine

You may qualify if:

• Age 5-11 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, Israel

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 4, 2022
• Study Start: January 10, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)