Techtrials Pesquisa e Tecnologia Ltda.
São Paulo, 05403-010, Brazil
NCT Number: NCT05697705
This study will address specific questions concerning the additional protection of the AZ COVID-19 vaccine as a second booster dose in preventing severe COVID-19 outcomes (hospitalisation, ICU admission etc) and will provide data to inform COVID-19 vaccine booster dose recommendations.
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Notify Me18 year and older
All sexes
Observational
São Paulo, 05403-010, Brazil
In Brazil, second COVID-19 boosters became available to specific risk groups in early 2022. By June 2022, immunocompromised individuals aged 12 years and above, individuals aged 50 years and above, and healthcare workers were eligible for a second booster. The vaccines available for second booster doses in Brazil are produced by AstraZeneca (AZ), Janssen, Pfizer and Sinovac.
While several studies have estimated absolute vaccine effectiveness (aVE) or relative vaccine effectiveness (rVE) of second boosters of mRNA COVID-19 vaccines, only a single study has, to date, estimated aVE of AZ vaccine as a second booster dose, and no studies have estimated rVE for AZ vaccine as a second booster dose. As the pandemic progresses, more individuals are choosing to become vaccinated (and boosted) against COVID-19 and thus there is greater need to evaluate the additional protection offered by a second booster dose amongst individuals previously administered a first booster. This is particularly important in the context of waning protection of a first booster dose.
The primary objective is to estimate relative vaccine effectiveness (rVE) against COVID-19 hospitalization of the AZ COVID-19 vaccine as a second booster dose relative to a first booster dose only, of any COVID-19 vaccine, administered at least four months ago.
This study will also evaluate rVE of other vaccines used in Brazil as a second booster doses. The study will further evaluate rVE of all vaccines (including the AZ-COVID-19 vaccine) as a first booster dose relative to a complete primary series only, of any COVID-19 vaccine administered at least four months ago."
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Used as 2nd booster, 1st booster, or primary series
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
Time frame: Sample date within 14 days prior to and up to 2 days after hospitalization.
Study includes SARS hospitalizations between August 2021 and December 2022 for evaluation of 1st booster dose effectiveness, and SARS hospitalizations between January 2022 and December 2022 for evaluation of 2nd booster dose effectiveness.
AstraZeneca
Industry
Real-world Effectiveness oF the OxfoRd-astrazeneca Covid-19 Vaccine as a Second bOoster Dose in Brazil (REFORCO-BRAZIL)
Acronym: REFORCO-B
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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