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Fever After Simultaneous Versus Sequential Vaccination in Young Children

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ClinicalTrials.gov Identifier: NCT03165981
Recruitment Status : Completed
First Posted : May 24, 2017
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Kaiser Permanente
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Fever After Vaccination
Fever
Febrile Seizure
Interventions Biological: PCV13
Biological: DTaP
Biological: IIV
Enrollment 221
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started [1] 110 111
Per Protocol Population [2] 99 107
Completed 99 107
Not Completed 11 4
[1]
Intent-to-treat Population: enrolled, randomized and received at least one study vaccine at V1
[2]
Excludes those w/o valid temperature data on D1-2 following V1-2 or with major protocol violations
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 99 107 206
Hide Baseline Analysis Population Description
Per Protocol Population
Age, Continuous  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 99 participants 107 participants 206 participants
14.1
(12.0 to 16.6)
14.8
(12.0 to 16.9)
14.7
(12.0 to 16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Female
48
  48.5%
55
  51.4%
103
  50.0%
Male
51
  51.5%
52
  48.6%
103
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Hispanic or Latino
21
  21.2%
22
  20.6%
43
  20.9%
Not Hispanic or Latino
78
  78.8%
85
  79.4%
163
  79.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
American Indian or Alaska Native
7
   7.1%
9
   8.4%
16
   7.8%
Asian
6
   6.1%
11
  10.3%
17
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.9%
2
   1.0%
Black or African American
10
  10.1%
6
   5.6%
16
   7.8%
White
52
  52.5%
57
  53.3%
109
  52.9%
More than one race
18
  18.2%
19
  17.8%
37
  18.0%
Unknown or Not Reported
6
   6.1%
3
   2.8%
9
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 99 participants 107 participants 206 participants
99 107 206
Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Any Private
63
  63.6%
84
  78.5%
147
  71.4%
Public
18
  18.2%
10
   9.3%
28
  13.6%
None
18
  18.2%
13
  12.1%
31
  15.0%
Number of Children Living in Home  
Median (Full Range)
Unit of measure:  Children
Number Analyzed 99 participants 107 participants 206 participants
2
(1 to 7)
2
(1 to 5)
2
(1 to 7)
Day Care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
Full-time (4-5 days/weeks)
22
  22.2%
34
  31.8%
56
  27.2%
Part-time (3 or less/weeks)
17
  17.2%
16
  15.0%
33
  16.0%
None
60
  60.6%
57
  53.3%
117
  56.8%
Gestational Age in Weeks  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 99 participants 107 participants 206 participants
39
(34 to 42)
39
(34 to 42)
39
(34 to 42)
Birth Weight in Pounds  
Median (Full Range)
Unit of measure:  Pounds
Number Analyzed 99 participants 107 participants 206 participants
7.25
(4.69 to 10.31)
7.13
(3.50 to 10.75)
7.13
(3.50 to 10.75)
Receipt of 1st or Only Dose of Influenza Vaccine for the Season  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
90
  90.9%
102
  95.3%
192
  93.2%
Receipt of 2nd Dose of Influenza Vaccine for the Season  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
9
   9.1%
5
   4.7%
14
   6.8%
Receipt of Concomitant Vaccine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 107 participants 206 participants
87
  87.9%
98
  91.6%
185
  89.8%
1.Primary Outcome
Title Number of Participants With Fever Following Vaccination
Hide Description 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.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
8
   8.1%
10
   9.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7588
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.36 to 2.10
Estimation Comments RR is adjusted by site.
2.Secondary Outcome
Title Number of Participants With Fever Visit 1
Hide Description Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
8
   8.1%
9
   8.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .9412
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.39 to 2.40
Estimation Comments RR is adjusted by site.
3.Secondary Outcome
Title Number of Participants With Fever Visit 2
Hide Description Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3408
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
4.Secondary Outcome
Title Number of Participants With Grade 2 and/or 3 Following Visit 1
Hide Description 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)
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.0%
5
   4.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8325
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.24 to 3.13
Estimation Comments RR is adjusted by site.
5.Secondary Outcome
Title Number of Participants With Grade 2 and/or 3 Following Visit 2
Hide Description Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3408
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
6.Secondary Outcome
Title Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2
Hide Description 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.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.0%
6
   5.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6101
Comments [Not Specified]
Method Mantel Haenszel
Comments Mantel Haenzel is stratified by site.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.21 to 2.48
Estimation Comments RR is adjusted by site.
7.Secondary Outcome
Title Duration of Fever - Visit 1
Hide Description 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.
Time Frame 8 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Mean (Full Range)
Unit of Measure: Fever Days
1.3
(1 to 2)
1.4
(1 to 3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Duration of Fever - Visit 2
Hide Description 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.
Time Frame 8 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Mean (Full Range)
Unit of Measure: Fever Days
0
(0 to 0)
3
(3 to 3)
9.Secondary Outcome
Title Duration of Fever - Visit 1 and 2 Combined
Hide Description 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.
Time Frame 8 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Mean (Full Range)
Unit of Measure: Fever Days
1.3
(1 to 2)
1.6
(1 to 3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simultaneous Vaccination Arm, Sequential Vaccination Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Medical Care Utilization - Visit 1
Hide Description 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.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Medical Care Utilization - Visit 2
Hide Description 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.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Medical Care Utilization - Visit 1 and 2 Combined
Hide Description 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.
Time Frame 2 days post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 99 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Adverse events were collected through 8 days post Visit 2.
Adverse Event Reporting Description 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.
 
Arm/Group Title Simultaneous Vaccination Arm Sequential Vaccination Arm
Hide Arm/Group Description

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

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

All-Cause Mortality
Simultaneous Vaccination Arm Sequential Vaccination Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)      0/107 (0.00%)    
Hide Serious Adverse Events
Simultaneous Vaccination Arm Sequential Vaccination Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/99 (0.00%)      1/107 (0.93%)    
General disorders     
Dehydration  [1]  0/99 (0.00%)  0 1/107 (0.93%)  1
Indicates events were collected by systematic assessment
[1]
Subject presented with fever, upper respiratory symptoms, decreased oral intake and dehydration 13 days after Visit 1. The SAE was considered unrelated to vaccination by the investigator.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Simultaneous Vaccination Arm Sequential Vaccination Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/99 (0.00%)      0/107 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Emmanuel B. Walter
Organization: Duke University
Phone: 919-620-5346
EMail: chip.walter@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03165981    
Other Study ID Numbers: Pro00082484
200 2012 53663 0009 ( Other Grant/Funding Number: CDC )
First Submitted: May 23, 2017
First Posted: May 24, 2017
Results First Submitted: December 31, 2018
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019