Trial Outcomes & Findings for FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging (NCT NCT01467934)

NCT ID: NCT01467934

Last Updated: 2014-07-21

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 530 participants
• Primary outcome timeframe: 8 days
• Results posted on: 2014-07-21

Participant Flow

Participant milestones

Measure	Trivalent Inactivated Influenza Vaccine (TIV) Alone Trivalent inactivated influenza vaccine 0.25ml IM X 1	TIV and PCV13 Together Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1	13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone 13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
Overall Study STARTED	208	212	110
Overall Study COMPLETED	208	212	110
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

Baseline characteristics by cohort

Measure	Trivalent Inactivated Influenza Vaccine (TIV) Alone n=208 Participants Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1	TIV and PCV13 Together n=212 Participants Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1	13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone n=110 Participants 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1	Total n=530 Participants Total of all reporting groups
Age, Customized 6-11 months	124 participants n=5 Participants	145 participants n=7 Participants	18 participants n=5 Participants	287 participants n=4 Participants
Age, Customized 12-23 months	84 participants n=5 Participants	67 participants n=7 Participants	92 participants n=5 Participants	243 participants n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	98 Participants n=7 Participants	64 Participants n=5 Participants	263 Participants n=4 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	114 Participants n=7 Participants	46 Participants n=5 Participants	267 Participants n=4 Participants
Race/Ethnicity, Customized Latino	171 participants n=5 Participants	187 participants n=7 Participants	100 participants n=5 Participants	458 participants n=4 Participants
Race/Ethnicity, Customized Black Latino	30 participants n=5 Participants	21 participants n=7 Participants	9 participants n=5 Participants	60 participants n=4 Participants
Race/Ethnicity, Customized White non-Latino	4 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants
Race/Ethnicity, Customized Other non-Latino	3 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.

Outcome measures

Measure	Trivalent Inactivated Influenza Vaccine (TIV) Alone n=159 Participants Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1	TIV and PCV13 Together n=170 Participants Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1	13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone n=84 Participants 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
Fever >= 100.4	7.5 percentage of participants	37.6 percentage of participants	9.5 percentage of participants

Adverse Events

Trivalent Inactivated Influenza Vaccine (TIV) Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TIV and PCV13 Together

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone

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

Melissa Stockwell

Columbia University

Phone: 212-342-5732

Email: mss2112@columbia.edu

Results disclosure agreements

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