Streptococcus Pneumoniae Infections
Conditions
Brief summary
This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.
Interventions
OTHERNasopharyngeal swab
Nasopharyngeal swab
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 12-18 months
Exclusion criteria
* Use of antibiotics up to 15 days prior to study inclusion * Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible * Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion. * Received any pneumococcal vaccine in the past. * Children who have already provided a NP sample in the same study period. * Any relevant hemorrhagic disorder. * Any febrile process (fever ≥ 38°C) at time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Day 1 | 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. |
| Percentage of Participants With Serotypes of Streptococcus Pneumoniae | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Day 1 | 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. |
| Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Day 1 | Categories are types of antibiotics. |
| Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Day 1 | Categories are types of antibiotics. |
| Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Day 1 | 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. |
| Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B | Day 1 | 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). |
| Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Day 1 | 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). |
| Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Day 1 | 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). |
| Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Day 1 | 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Per-protocol Population 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. | 3,600 |
| Total | 3,600 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Noncoordination | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Per-protocol Population |
|---|---|
| Age Continuous | 14.9 months STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 1718 Participants |
| Sex: Female, Male Male | 1882 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,600 |
| serious Total, serious adverse events | 0 / 3,600 |
Outcome results
Primary
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Beijing (n=600) | 12.5 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Shanghai (n=614) | 7.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Jinan (n=594) | 16.6 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Nanjing (n=598) | 9.3 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Wuhan (n=596) | 10.5 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | Dongguan (n=598) | 18.9 percentage of participants |
Primary
Percentage of Participants With Serotypes of Streptococcus Pneumoniae
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.
Time frame: Day 1
Population: PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 6B | 6.4 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | NO6A/NO6B | 3.5 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 17 | 2.0 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | NO23F | 2.0 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 18 | 1.6 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 10 | 1.1 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 8 | 0.9 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 11 | 0.9 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 20 | 0.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 22 | 0.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 33 | 0.4 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 7 | 0.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 4 | 0.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 9 | 0.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | NO19A/NO19F | 0.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | G | 8.9 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | H | 3.1 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | D | 0.9 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | I | 0.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | E | 0.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | F | 0.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | NO(Without capsule) | 3.5 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 23F | 6.0 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 6A | 5.8 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 19F | 28.4 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 14 | 7.5 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 19A | 6.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 15 | 6.7 percentage of participants |
Secondary
Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Categories are types of antibiotics.
Time frame: Day 1
Population: PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Cefuroxime | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Cefatriaxone | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Azithromycin | 1.2 percentage of isolates |
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Levofloxacin | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Moxifloxacin | 2.4 percentage of isolates |
| Per-protocol Population | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Ampicillin | 19.6 percentage of isolates |
Secondary
Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Categories are types of antibiotics.
Time frame: Day 1
Population: PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Cefuroxime | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Cefatriaxone | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Azithromycin | 21.0 percentage of isolates |
| Per-protocol Population | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Levofloxacin | 0.0 percentage of isolates |
| Per-protocol Population | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Erythromycin | 22.7 percentage of isolates |
Secondary
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
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.
Time frame: Day 1
Population: PP. n=number of participants analyzed at that site.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Beijing (n=600) | 4.3 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Shanghai (n=614) | 8.0 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Jinan (n=594) | 5.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Nanjing (n=598) | 2.3 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Wuhan (n=596) | 3.4 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | Dongguan (n=598) | 4.2 percentage of participants |
Secondary
Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
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.
Time frame: Day 1
Population: PP. n=number of participants analyzed at that site.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Beijing (n=600) | 11.7 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Shanghai (n=614) | 11.1 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Jinan (n=594) | 9.8 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Nanjing (n=598) | 7.9 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Wuhan (n=596) | 8.2 percentage of participants |
| Per-protocol Population | Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | Dongguan (n=598) | 17.4 percentage of participants |
Secondary
Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
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.
Time frame: Day 1
Population: PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Penicillin (Old Criteria) | 18.6 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Penicillin | 1.1 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Amoxicillin/clavulanic acid | 1.1 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Cefuroxime | 23.5 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Cefatriaxone | 4.0 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Azithromycin | 83.6 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Erythromycin | 83.6 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Levofloxacin | 0.2 percentage of isolates |
| Per-protocol Population | Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | Moxifloxacin | 0.0 percentage of isolates |
Secondary
Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
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).
Time frame: Day 1
Population: PP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per-protocol Population | 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 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B | Household register, local vs nonlocal | -0.204 relative risk | Standard Error 0.099 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
Comparison: Birth information, preterm birth vs full-term birthp-value: 0.05795% CI: [0.062, 1.044]Chi-squared
Comparison: Household register, local vs nonlocalp-value: 0.0495% CI: [0.451, 0.981]Chi-squared
Comparison: Feeding manners within 6 months, pure breast feeding vs pure formula milk feedingp-value: 0.04495% CI: [0.758, 1.844]Chi-squared
Comparison: Feeding manners within 6 months, mixed feeding vs pure formula milk feedingp-value: 0.03895% CI: [0.42, 1.191]Chi-squared
Comparison: Father's education level, illiteracy vs postgraduate or abovep-value: 0.00695% CI: [3.993, 2130.5]Chi-squared
Comparison: Father's education level, elementary school vs postgraduate or abovep-value: 0.77895% CI: [0.537, 40.608]Chi-squared
Comparison: Father's education level, junior high school vs postgraduate or abovep-value: 0.75695% CI: [0.649, 35.956]Chi-squared
Comparison: Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or abovep-value: 0.17995% CI: [0.474, 26.03]Chi-squared
Comparison: Father's education level, college/university vs postgraduate or abovep-value: 0.07795% CI: [0.412, 22.292]Chi-squared
Comparison: Living space per capita, continuous variablesp-value: 0.05695% CI: [0.968, 1]Chi-squared
Comparison: Vaccination history of Hib, no vs yesp-value: 0.06495% CI: [0.522, 1.018]Chi-squared
Secondary
Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
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).
Time frame: Day 1
Population: PP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Birth information, preterm vs full-term birth | -0.412 relative risk | Standard Error 0.175 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Household register, local vs nonlocal | -0.303 relative risk | Standard Error 0.065 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Mother's education, illiteracy vs graduate | 0.280 relative risk | Standard Error 0.479 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Mother's education, elementary vs graduate | 0.104 relative risk | Standard Error 0.214 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Mother's education, junior middle vs graduate | 0.199 relative risk | Standard Error 0.153 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Mother's education, senior high vs postgraduate | 0.166 relative risk | Standard Error 0.159 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | Mother's education, college vs postgraduate | -0.270 relative risk | Standard Error 0.174 |
| Per-protocol Population | 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 |
Comparison: Birth information, preterm birth vs full-term birthp-value: 0.01995% CI: [0.221, 0.871]Chi-squared
Comparison: Household register, local vs nonlocalp-value: <0.00195% CI: [0.423, 0.703]Chi-squared
Comparison: Mother's education level, illiteracy vs graduate or abovep-value: 0.55995% CI: [0.473, 9.652]Chi-squared
Comparison: Mother's education level, elementary school vs graduate or abovep-value: 0.62695% CI: [0.596, 5.394]Chi-squared
Comparison: Mother's education level, junior middle school vs graduate or abovep-value: 0.19395% CI: [0.699, 5.562]Chi-squared
Comparison: Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or abovep-value: 0.29895% CI: [0.679, 5.353]Chi-squared
Comparison: Mother's education level, college/university vs postgraduate or abovep-value: 0.12295% CI: [0.439, 3.464]Chi-squared
Comparison: Whether have brothers or sisters, no vs yesp-value: 0.00195% CI: [0.52, 0.855]Chi-squared
Secondary
Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
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).
Time frame: Day 1
Population: PP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Age of mother bearing, <=30 years vs >30 years | 0.248 relative risk | Standard Error 0.07 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Household register, local vs nonlocal | -0.116 relative risk | Standard Error 0.062 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Mother's education, illiteracy vs postgraduate | 1.087 relative risk | Standard Error 0.396 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Mother's education, elementary vs postgraduate | 0.326 relative risk | Standard Error 0.199 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Mother's education, junior middle vs postgraduate | 0.209 relative risk | Standard Error 0.149 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Mother's education, senior high vs postgraduate | -0.068 relative risk | Standard Error 0.157 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Mother's education, college vs postgraduate | -0.643 relative risk | Standard Error 0.175 |
| Per-protocol Population | Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | Monthly income, <600 RMB vs >=10000 RMB | 0.508 relative risk | Standard Error 0.251 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
| Per-protocol Population | 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 |
Comparison: Age of mother bearing, \<=30 years vs \>30 yearsp-value: <0.00195% CI: [1.247, 2.159]Chi-squared
Comparison: Household register, local vs nonlocalp-value: 0.0695% CI: [0.622, 1.01]Chi-squared
Comparison: Mother's education level, illiteracy vs postgraduate or abovep-value: 0.00695% CI: [1.672, 32.479]Chi-squared
Comparison: Mother's education level, elementary school vs postgraduate or abovep-value: 0.10295% CI: [1.001, 11.843]Chi-squared
Comparison: Mother's education level, junior middle school vs postgraduate or abovep-value: 0.15995% CI: [0.933, 10.067]Chi-squared
Comparison: Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or abovep-value: 0.66295% CI: [0.71, 7.589]Chi-squared
Comparison: Mother's education level, college/university vs postgraduate or abovep-value: <0.00195% CI: [0.399, 4.277]Chi-squared
Comparison: Family monthly income per capita, \<=600 RMB vs \>=10000 RMBp-value: 0.04395% CI: [0.719, 6.831]Chi-squared
Comparison: Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMBp-value: 0.0195% CI: [0.739, 5.906]Chi-squared
Comparison: Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMBp-value: 0.02195% CI: [0.704, 5.583]Chi-squared
Comparison: Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMBp-value: 0.36495% CI: [0.344, 3.267]Chi-squared
p-value: 0.17595% CI: [0.1, 3.347]Chi-squared
Comparison: Whether have brothers or sisters, no vs yesp-value: <0.00195% CI: [0.4, 0.666]Chi-squared