Trial Outcomes & Findings for Pneumococcal Nasopharyngeal and Oropharyngeal Carriage in Adults (NCT NCT04831788)

Last Updated: 2023-11-01

Results Overview

Prevalence will be measured as a number of participants with positive isolates divided with overall number of participants analyzed and multiplied by a hundred to determine a percentage of positives

Recruitment status

COMPLETED

Target enrollment

521 participants

Primary outcome timeframe

90 days

Results posted on

2023-11-01

Participant Flow

Unit of analysis: nasopharyngeal and oropharyngeal swab

Participant milestones

Participant milestones
Measure	Pneumococcal Nasopharyngeal and Oropharyngeal Carriage Adults older than 50 years of age, residing in the city of Novi Sad, Serbia and providing oropharyngeal and nasopharyngeal swab specimen upon signing informed consent
Overall Study STARTED	521 1042
Overall Study COMPLETED	521 1042
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pneumococcal Nasopharyngeal and Oropharyngeal Carriage in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pneumococcal Nasopharyngeal and Oropharyngeal Carriage n=521 Participants Adults older than 50 years of age, residing in the city of Novi Sad, Serbia and providing oropharyngeal and nasopharyngeal swab specimen upon signing informed consent
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	324 Participants n=5 Participants
Sex: Female, Male Male	197 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	521 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Serbia	521 participants n=5 Participants
Number of Participants	521 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Prevalence was measured as a percentage of participants with Spn positive isolates

Prevalence will be measured as a number of participants with positive isolates divided with overall number of participants analyzed and multiplied by a hundred to determine a percentage of positives

Outcome measures

Outcome measures
Measure	Pneumococcal Nasopharyngeal and Oropharyngeal Carriage n=521 Participants Adults older than 50 years of age, residing in the city of Novi Sad, Serbia and providing oropharyngeal and nasopharyngeal swab specimen upon signing informed consent
Prevalence	16 Participants

SECONDARY outcome

Timeframe: 150 days

Population: participants with Spn positive isolates

Serotype on NP and OP carriage with pneumococcal serotypes among adults older than 50 years of age in the city of Novi Sad according to specific clinical indications set for the PPV or PCV

Outcome measures

Outcome measures
Measure	Pneumococcal Nasopharyngeal and Oropharyngeal Carriage n=16 Participants Adults older than 50 years of age, residing in the city of Novi Sad, Serbia and providing oropharyngeal and nasopharyngeal swab specimen upon signing informed consent
Number of Participants With Spn Serotypes Non Typeable serotypes	10 Participants
Number of Participants With Spn Serotypes Typeable serotypes	6 Participants

Adverse Events

Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Vladimir Petrovic

University of Novi Sad, Faculty of Medicine

Phone: +381648028800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place