Trial Outcomes & Findings for Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage (NCT NCT01109108)
NCT ID: NCT01109108
Last Updated: 2017-03-14
Results Overview
Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae
Recruitment status
COMPLETED
Target enrollment
9000 participants
Primary outcome timeframe
Study years 1-5
Results posted on
2017-03-14
Participant Flow
Children aged 0\<60 months with non-toxic appearance presenting for well child or urgent care visit at urban hospital recruited from July 1, 2010 - March 27, 2015; each child could be enrolled only once per 60 day period.
Participant milestones
| Measure |
Children 0<2 Years of Age
Children 0\<2 years of age with and without respiratory tract infection
|
Children 2<5 Years of Age
Children 2\<5 years of age with and without respiratory tract infection
|
|---|---|---|
|
Overall Study
STARTED
|
4035
|
4755
|
|
Overall Study
COMPLETED
|
4035
|
4755
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
Baseline characteristics by cohort
| Measure |
Children 0<2 Years of Age
n=4035 Participants
Children 0\<2 years of age with and without concurrent respiratory tract infection
|
Children 2<5 Years of Age
n=4755 Participants
Children 2\<5 years of age with and without concurrent respiratory tract infection
|
Total
n=8790 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4035 Participants
n=5 Participants
|
4755 Participants
n=7 Participants
|
8790 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.1 months
STANDARD_DEVIATION 5.7 • n=5 Participants
|
40.0 months
STANDARD_DEVIATION 10.3 • n=7 Participants
|
27.2 months
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1935 Participants
n=5 Participants
|
2402 Participants
n=7 Participants
|
4337 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2100 Participants
n=5 Participants
|
2353 Participants
n=7 Participants
|
4453 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2719 Participants
n=5 Participants
|
3445 Participants
n=7 Participants
|
6164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
445 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
796 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
739 Participants
n=5 Participants
|
828 Participants
n=7 Participants
|
1567 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4035 participants
n=5 Participants
|
4755 participants
n=7 Participants
|
8790 participants
n=5 Participants
|
|
Pneumococcal risk factors
Current RTI (Respiratory tract infection) · Yes
|
1839 Participants
n=5 Participants
|
2108 Participants
n=7 Participants
|
3947 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Current RTI (Respiratory tract infection) · No
|
2196 Participants
n=5 Participants
|
2647 Participants
n=7 Participants
|
4843 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Recent antibiotic use (last 14 days) · Yes
|
535 Participants
n=5 Participants
|
451 Participants
n=7 Participants
|
986 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Recent antibiotic use (last 14 days) · No
|
3500 Participants
n=5 Participants
|
4304 Participants
n=7 Participants
|
7804 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Ever Breastfed · Yes
|
3222 Participants
n=5 Participants
|
3684 Participants
n=7 Participants
|
6906 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Ever Breastfed · No
|
813 Participants
n=5 Participants
|
1071 Participants
n=7 Participants
|
1884 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Current daycare attendance · Yes
|
1217 Participants
n=5 Participants
|
2887 Participants
n=7 Participants
|
4104 Participants
n=5 Participants
|
|
Pneumococcal risk factors
Current daycare attendance · No
|
2818 Participants
n=5 Participants
|
1868 Participants
n=7 Participants
|
4686 Participants
n=5 Participants
|
|
Pneumococcal risk factors
PCV13 Immune · Yes
|
3240 Participants
n=5 Participants
|
3923 Participants
n=7 Participants
|
7163 Participants
n=5 Participants
|
|
Pneumococcal risk factors
PCV13 Immune · No
|
795 Participants
n=5 Participants
|
832 Participants
n=7 Participants
|
1627 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study years 1-5Population: Children colonized with any S. pneumoniae (PCV and non-PCV serotypes)
Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae
Outcome measures
| Measure |
Children 0<2 Years of Age
n=882 Participants
Children 0\<2 years of age with and without respiratory tract infection
|
Children 2<5 Years of Age
n=969 Participants
Children 2\<5 years of age with and without respiratory tract infection
|
|---|---|---|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2014-2015 · Non-PCV13 serotype
|
64 Participants
|
92 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2010-2011 · PCV13 serotype
|
20 Participants
|
31 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2010-2011 · Non-PCV13 serotype
|
166 Participants
|
137 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2011-2012 · PCV13 serotype
|
23 Participants
|
11 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2011-2012 · Non-PCV13 serotype
|
306 Participants
|
297 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2012-2013 · PCV13 serotype
|
6 Participants
|
5 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2012-2013 · Non-PCV13 serotype
|
187 Participants
|
239 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2013-2014 · PCV13 serotype
|
2 Participants
|
5 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2013-2014 · Non-PCV13 serotype
|
108 Participants
|
150 Participants
|
|
Nasopharngeal Colonization With PCV13 S. Pneumoniae
2014-2015 · PCV13 serotype
|
0 Participants
|
2 Participants
|
Adverse Events
Children <2 Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children 2<5 Years of Age
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place