Trial Outcomes & Findings for Fever After Simultaneous Versus Sequential Vaccination in Young Children (NCT NCT03165981)
NCT ID: NCT03165981
Last Updated: 2024-11-18
Results Overview
Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
221 participants
Primary outcome timeframe
2 days post administration
Results posted on
2024-11-18
Participant Flow
Participant milestones
| Measure |
Simultaneous Vaccination Arm
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
111
|
|
Overall Study
Per Protocol Population
|
99
|
107
|
|
Overall Study
COMPLETED
|
99
|
107
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fever After Simultaneous Versus Sequential Vaccination in Young Children
Baseline characteristics by cohort
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 Months
n=93 Participants
|
14.8 Months
n=4 Participants
|
14.7 Months
n=27 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=93 Participants
|
107 participants
n=4 Participants
|
206 participants
n=27 Participants
|
|
Insurance
Any Private
|
63 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Insurance
Public
|
18 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Insurance
None
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Number of Children Living in Home
|
2 Children
n=93 Participants
|
2 Children
n=4 Participants
|
2 Children
n=27 Participants
|
|
Day Care
Full-time (4-5 days/weeks)
|
22 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Day Care
Part-time (3 or less/weeks)
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Day Care
None
|
60 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Gestational Age in Weeks
|
39 Weeks
n=93 Participants
|
39 Weeks
n=4 Participants
|
39 Weeks
n=27 Participants
|
|
Birth Weight in Pounds
|
7.25 Pounds
n=93 Participants
|
7.13 Pounds
n=4 Participants
|
7.13 Pounds
n=27 Participants
|
|
Receipt of 1st or Only Dose of Influenza Vaccine for the Season
|
90 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
|
Receipt of 2nd Dose of Influenza Vaccine for the Season
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Receipt of Concomitant Vaccine
|
87 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
185 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Fever Following Vaccination
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Fever Visit 1
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Fever Visit 2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.6°C or ≥ 101.4°F)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Fever Following Visit 1
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Fever Following Visit 2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 days post administrationPopulation: Per Protocol Population
Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 1. Note: fever starting on day 1 or 2 could continue through day 8.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Duration of Fever - Visit 1
|
1.3 Fever Days
Interval 1.0 to 2.0
|
1.4 Fever Days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 8 days post administrationPopulation: Per Protocol Population
Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 2. Note: fever starting on day 1 or 2 could continue through day 8.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Duration of Fever - Visit 2
|
0 Fever Days
Interval 0.0 to 0.0
|
3 Fever Days
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: 8 days post administrationPopulation: Per Protocol Population
Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1 and Visit 2 combined. Note: fever starting on day 1 or 2 could continue through day 8.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Duration of Fever - Visit 1 and 2 Combined
|
1.3 Fever Days
Interval 1.0 to 2.0
|
1.6 Fever Days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Medical Care Utilization - Visit 1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 2.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Medical Care Utilization - Visit 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 days post administrationPopulation: Per Protocol Population
Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1 and Visit 2 combined.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=99 Participants
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 Participants
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
Number of Participants With Medical Care Utilization - Visit 1 and 2 Combined
|
0 Participants
|
0 Participants
|
Adverse Events
Simultaneous Vaccination Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequential Vaccination Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simultaneous Vaccination Arm
n=99 participants at risk
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
Sequential Vaccination Arm
n=107 participants at risk
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|---|---|---|
|
General disorders
Dehydration
|
0.00%
0/99 • Adverse events were collected through 8 days post Visit 2.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 1% (febrile seizure only) were collected and reported. Per protocol, the only AE collected was febrile seizure.
|
0.93%
1/107 • Number of events 1 • Adverse events were collected through 8 days post Visit 2.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 1% (febrile seizure only) were collected and reported. Per protocol, the only AE collected was febrile seizure.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place