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Trial Outcomes & Findings for Seroepidemiological Study of Pertussis and Other Infectious Diseases (NCT NCT01929473)

NCT ID: NCT01929473

Last Updated: 2016-07-12

Results Overview

Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).

Recruitment status

COMPLETED

Target enrollment

3830 participants

Primary outcome timeframe

0 day, 365 day (2 points)

Results posted on

2016-07-12

Participant Flow

Participant milestones

Participant milestones
Measure
Blood Drawings (0 Day, 365 Day) and Questionnaires
Overall Study
STARTED
3830
Overall Study
365 Day
3589
Overall Study
COMPLETED
3243
Overall Study
NOT COMPLETED
587

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seroepidemiological Study of Pertussis and Other Infectious Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Blood Drawings (0 Day, 365 Day) and Questionnaires
n=3243 Participants
Age, Continuous
13.9 years
STANDARD_DEVIATION 1.56 • n=39 Participants
Sex: Female, Male
Female
1605 Participants
n=39 Participants
Sex: Female, Male
Male
1638 Participants
n=39 Participants
Region of Enrollment
Japan
3243 participants
n=39 Participants

PRIMARY outcome

Timeframe: 0 day, 365 day (2 points)

Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).

Outcome measures

Outcome measures
Measure
Blood Drawings (0 Day, 365 Day) and Questionnaires
n=3243 Participants
IgG
0 day
1.254 EU/mL(log transformed)
Standard Deviation 0.008
IgG
365 day
1.258 EU/mL(log transformed)
Standard Deviation 0.007

SECONDARY outcome

Timeframe: 0 day

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 day

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 365 day

Questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Blood Drawings (0 Day, 365 Day) and Questionnaires

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

Tsutomu Takeda

IROM CS Co., Ltd.

Phone: +81-92-738-0500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER