Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-06

Study Completion Date

2024-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Drug Use Investigation of COMIRNATY Intramuscular Injection

NCT04815031

COVID-19

COMPLETED

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

NCT05007080

Coronavirus Disease-2019 (COVID-19) Prevention

COMPLETED PHASE2

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

NCT00944034

Meningococcal Disease Meningococcal Meningitis

COMPLETED PHASE2/PHASE3

One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

NCT01139021

Meningococcal Disease

COMPLETED PHASE3

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

NCT04796896

SARS-CoV-2

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COMIRNATY intramuscular injection for 6 months to 4 years old (monovalent, omicron XBB.1.5.)

COMIRNATY intramuscular injection

Intervention Type BIOLOGICAL

Booster injection in the muscle, 1 dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COMIRNATY intramuscular injection

Booster injection in the muscle, 1 dose

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study.

Minimum Eligible Age

6 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes