Trial Outcomes & Findings for Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China (NCT NCT00952367)
NCT ID: NCT00952367
Last Updated: 2012-04-23
Results Overview
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
COMPLETED
3641 participants
Day 1
2012-04-23
Participant Flow
In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population.
Participant milestones
| Measure |
All Enrolled Participants
Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
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|---|---|
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Overall Study
STARTED
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3641
|
|
Overall Study
COMPLETED
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3635
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
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Overall Study
Noncoordination
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1
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|
Overall Study
Protocol Violation
|
3
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Baseline Characteristics
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Baseline characteristics by cohort
| Measure |
Per-protocol Population
n=3600 Participants
In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Age Continuous
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14.9 months
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
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1718 Participants
n=5 Participants
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Sex: Female, Male
Male
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1882 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1Population: Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Beijing (n=600)
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12.5 percentage of participants
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Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Shanghai (n=614)
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7.2 percentage of participants
|
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Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Jinan (n=594)
|
16.6 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Nanjing (n=598)
|
9.3 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Wuhan (n=596)
|
10.5 percentage of participants
|
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Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Dongguan (n=598)
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18.9 percentage of participants
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PRIMARY outcome
Timeframe: Day 1Population: PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.
Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.
Outcome measures
| Measure |
Per-protocol Population
n=451 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
19F
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28.4 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
14
|
7.5 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
19A
|
6.7 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
15
|
6.7 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
6B
|
6.4 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
NO6A/NO6B
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3.5 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
NO23F
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2.0 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
18
|
1.6 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
10
|
1.1 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
8
|
0.9 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
11
|
0.9 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
20
|
0.7 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
22
|
0.7 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
33
|
0.4 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
7
|
0.2 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
4
|
0.2 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
9
|
0.2 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
NO19A/NO19F
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0.2 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
G
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8.9 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
H
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3.1 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
D
|
0.9 percentage of participants
|
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
I
|
0.7 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
E
|
0.7 percentage of participants
|
|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
F
|
0.2 percentage of participants
|
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
NO(Without capsule)
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3.5 percentage of participants
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|
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
23F
|
6.0 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
6A
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5.8 percentage of participants
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
17
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2.0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: PP. n=number of participants analyzed at that site.
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Beijing (n=600)
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4.3 percentage of participants
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Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Shanghai (n=614)
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8.0 percentage of participants
|
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Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Jinan (n=594)
|
5.7 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Nanjing (n=598)
|
2.3 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Wuhan (n=596)
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3.4 percentage of participants
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Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Dongguan (n=598)
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4.2 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: PP. n=number of participants analyzed at that site.
A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
|
|---|---|
|
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Beijing (n=600)
|
11.7 percentage of participants
|
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Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Shanghai (n=614)
|
11.1 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Jinan (n=594)
|
9.8 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Nanjing (n=598)
|
7.9 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Wuhan (n=596)
|
8.2 percentage of participants
|
|
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Dongguan (n=598)
|
17.4 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.
Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.
Outcome measures
| Measure |
Per-protocol Population
n=451 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Penicillin (Old Criteria)
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18.6 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Penicillin
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1.1 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Amoxicillin/clavulanic acid
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1.1 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Cefuroxime
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23.5 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Cefatriaxone
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4.0 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Azithromycin
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83.6 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Erythromycin
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83.6 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Levofloxacin
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0.2 percentage of isolates
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Moxifloxacin
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0.0 percentage of isolates
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SECONDARY outcome
Timeframe: Day 1Population: PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.
Categories are types of antibiotics.
Outcome measures
| Measure |
Per-protocol Population
n=168 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Cefatriaxone
|
0.0 percentage of isolates
|
|
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Azithromycin
|
1.2 percentage of isolates
|
|
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Levofloxacin
|
0.0 percentage of isolates
|
|
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Moxifloxacin
|
2.4 percentage of isolates
|
|
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Ampicillin
|
19.6 percentage of isolates
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Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Cefuroxime
|
0.0 percentage of isolates
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SECONDARY outcome
Timeframe: Day 1Population: PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.
Categories are types of antibiotics.
Outcome measures
| Measure |
Per-protocol Population
n=396 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Cefuroxime
|
0.0 percentage of isolates
|
|
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Cefatriaxone
|
0.0 percentage of isolates
|
|
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Azithromycin
|
21.0 percentage of isolates
|
|
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Levofloxacin
|
0.0 percentage of isolates
|
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Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Erythromycin
|
22.7 percentage of isolates
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SECONDARY outcome
Timeframe: Day 1Population: PP
Risk factors include age of mother bearing (less than or equal to \[\<=\] 30 years versus \[vs\] more than \[\>\] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi \[RMB\], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to \[\>=\] 10000 RMB); whether have brothers or sisters (yes vs no).
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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|---|---|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Age of mother bearing, <=30 years vs >30 years
|
0.248 relative risk
Standard Error 0.070
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Household register, local vs nonlocal
|
-0.116 relative risk
Standard Error 0.062
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Mother's education, illiteracy vs postgraduate
|
1.087 relative risk
Standard Error 0.396
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Mother's education, elementary vs postgraduate
|
0.326 relative risk
Standard Error 0.199
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Mother's education, junior middle vs postgraduate
|
0.209 relative risk
Standard Error 0.149
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Mother's education, senior high vs postgraduate
|
-0.068 relative risk
Standard Error 0.157
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Mother's education, college vs postgraduate
|
-0.643 relative risk
Standard Error 0.175
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Monthly income, <600 RMB vs >=10000 RMB
|
0.508 relative risk
Standard Error 0.251
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Monthly income, 600 to 1999 RMB vs >= 10000 RMB
|
0.448 relative risk
Standard Error 0.175
|
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Monthly income, 2000 to 4999 RMB vs >= 10000 RMB
|
0.396 relative risk
Standard Error 0.172
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Monthly income, 5000-7999 RMB vs >= 10000 RMB
|
-0.230 relative risk
Standard Error 0.254
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Monthly income, 8000 to 9999 RMB vs >= 10000 RMB
|
-0.834 relative risk
Standard Error 0.615
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Whether have brothers or sisters, no vs yes
|
-0.331 relative risk
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Day 1Population: PP
Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
|
|---|---|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Birth information, preterm vs full-term birth
|
-0.683 relative risk
Standard Error 0.359
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Household register, local vs nonlocal
|
-0.204 relative risk
Standard Error 0.099
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Feeding, pure breast feeding vs pure formula milk
|
0.227 relative risk
Standard Error 0.113
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Feeding, mixed feeding vs pure formula milk
|
-0.287 relative risk
Standard Error 0.138
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Father's education, illiteracy vs postgraduate
|
2.857 relative risk
Standard Error 1.047
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Father's education, junior middle vs postgraduate
|
-0.093 relative risk
Standard Error 0.298
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Father's education, senior high vs postgraduate
|
-0.411 relative risk
Standard Error 0.306
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Father's education, college vs postgraduate
|
-0.559 relative risk
Standard Error 0.316
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Father's education, elementary vs postgraduate
|
-0.126 relative risk
Standard Error 0.448
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Living space per capita, continuous variables
|
-0.016 relative risk
Standard Error 0.009
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Vaccination history of Hib, no vs yes
|
-0.158 relative risk
Standard Error 0.085
|
SECONDARY outcome
Timeframe: Day 1Population: PP
Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).
Outcome measures
| Measure |
Per-protocol Population
n=3600 Participants
Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
|
|---|---|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Birth information, preterm vs full-term birth
|
-0.412 relative risk
Standard Error 0.175
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Household register, local vs nonlocal
|
-0.303 relative risk
Standard Error 0.065
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Mother's education, illiteracy vs graduate
|
0.280 relative risk
Standard Error 0.479
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Mother's education, elementary vs graduate
|
0.104 relative risk
Standard Error 0.214
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Mother's education, junior middle vs graduate
|
0.199 relative risk
Standard Error 0.153
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Mother's education, senior high vs postgraduate
|
0.166 relative risk
Standard Error 0.159
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Mother's education, college vs postgraduate
|
-0.270 relative risk
Standard Error 0.174
|
|
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Whether have brothers or sisters, no vs yes
|
-0.203 relative risk
Standard Error 0.063
|
Adverse Events
Per-protocol Population
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 Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER