Fever
Conditions
Brief summary
In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.
Interventions
None listed
Sponsors
Centers for Disease Control and Prevention
Columbia University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No
Inclusion criteria
1. are 6 through 23 month olds, 2. have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012, 3. receive trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)concomitantly, trivalent inactivated influenza vaccine (TIV)/without 13-valent pneumococcal conjugate vaccine (PCV13) or 13-valent pneumococcal conjugate vaccine (PCV13) without trivalent inactivated influenza vaccine (TIV)/(4) parent has a cell phone with text messaging capabilities; and (5) parent speaks English or Spanish.
Exclusion criteria
1. presence of fever \>=100.4 at time of vaccination; 2. administration of any antipyretic in the 6-hour period prior to vaccination 3. stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever; 4. stated intention to move away from the NYC area \<6 month; 5. parent only speaks a language other than English or Spanish; 6. inability to read text messages; 7. children who received live attenuated influenza vaccine (LAIV) this visit; 8. children who received trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) in the seven days prior to enrollment date Note: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fever >= 100.4 | 8 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trivalent Inactivated Influenza Vaccine (TIV) Alone Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 | 208 |
| 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 | 212 |
| 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | 110 |
| Total | 530 |
Baseline characteristics
| Characteristic | Trivalent Inactivated Influenza Vaccine (TIV) Alone | TIV and PCV13 Together | 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | Total |
|---|---|---|---|---|
| Age, Customized 12-23 months | 84 participants | 67 participants | 92 participants | 243 participants |
| Age, Customized 6-11 months | 124 participants | 145 participants | 18 participants | 287 participants |
| Race/Ethnicity, Customized Black Latino | 30 participants | 21 participants | 9 participants | 60 participants |
| Race/Ethnicity, Customized Latino | 171 participants | 187 participants | 100 participants | 458 participants |
| Race/Ethnicity, Customized Other non-Latino | 3 participants | 2 participants | 0 participants | 5 participants |
| Race/Ethnicity, Customized White non-Latino | 4 participants | 2 participants | 1 participants | 7 participants |
| Sex: Female, Male Female | 101 Participants | 98 Participants | 64 Participants | 263 Participants |
| Sex: Female, Male Male | 107 Participants | 114 Participants | 46 Participants | 267 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 208 | 0 / 212 | 0 / 110 |
| serious Total, serious adverse events | 0 / 208 | 0 / 212 | 0 / 110 |
Outcome results
Primary
Fever >= 100.4
Time frame: 8 days
Population: Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Inactivated Influenza Vaccine (TIV) Alone | Fever >= 100.4 | 7.5 percentage of participants |
| TIV and PCV13 Together | Fever >= 100.4 | 37.6 percentage of participants |
| 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | Fever >= 100.4 | 9.5 percentage of participants |