A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01298544
Collaborator
(none)
335
10
1
3.9
33.5
8.5
Study Details
Study Description
Brief Summary
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
335 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518
Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Mar 1, 2011
Actual Study Completion Date
:
Mar 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: All subjects
|
Procedure: Blood draw
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose [Day 1 (36 months after toddler dose)]
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Other Outcome Measures
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose [Day 1 (36 months after toddler dose)]
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female subjects who participated in and completed Wyeth study 0887X 101518.
-
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
-
Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
-
History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
-
Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chengxiang Town Hospital | Longan County | Guangxi | China | 532700 |
| 2 | Longan County CDC | Longan County | Guangxi | China | 532700 |
| 3 | Nanyu Town Hospital | Longan County | Guangxi | China | 532701 |
| 4 | Yanjiang Town Hospital | Longan County | Guangxi | China | 532702 |
| 5 | Natong Town Hospital | Longan County | Guangxi | China | 532703 |
| 6 | Qiaojian Town Hospital | Longan County | Guangxi | China | 532707 |
| 7 | Gutan Village Hospital | Longan County | Guangxi | China | 532708 |
| 8 | Dingdang Town Hospital | Longan County | Guangxi | China | 532709 |
| 9 | Yangwan Hospital | Longan County | Guangxi | China | 532715 |
| 10 | GuangXi Center for Disease Prevention and Control | Nanning | Guangxi | China | 530028 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01298544
Other Study ID Numbers:
- B1841009
- 6114A1-4001
First Posted:
Feb 17, 2011
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | All eligible participants who completed a previous study, 0887X-101518 (NCT00488826), were invited to participate in this study, at a timepoint at least 3 years after their last vaccination in study 0887X-101518. |
|---|---|
| Pre-assignment Detail | No vaccines administered during study. However, participants assessed according to the vaccine group they were assigned to in study 0887X-101518: 7-valent pneumococcal conjugate vaccine (7vPnC) alone (Group 1), 7vPnC given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Group 2), or DTaP alone (Group 3). |
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | All randomized participants |
| Period Title: Overall Study | |
| STARTED | 335 |
| COMPLETED | 335 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | All randomized participants |
| Overall Participants | 335 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
5.04
(0.150)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
149
44.5%
|
| Male |
186
55.5%
|
Outcome Measures
| Title | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose |
|---|---|
| Description | Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. |
| Time Frame | Day 1 (36 months after toddler dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations. |
| Arm/Group Title | 7vPnC | 7vPnC and DTaP | DTaP Alone |
|---|---|---|---|
| Arm/Group Description | No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age. | No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age. | No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3). |
| Measure Participants | 123 | 121 | 91 |
| Serotype 4 |
0.98
|
0.66
|
0.41
|
| Serotype 6B |
11.35
|
9.24
|
3.37
|
| Serotype 9V |
1.35
|
1.29
|
1.05
|
| Serotype 14 |
4.50
|
3.02
|
0.55
|
| Serotype 18C |
0.80
|
0.77
|
0.34
|
| Serotype 19F |
10.14
|
5.67
|
1.70
|
| Serotype 23F |
3.31
|
2.71
|
1.44
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 4 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.68 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 0.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 6B | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 9V | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 14 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.67 | |
| Confidence Interval |
(2-Sided) 95% 0.45 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 18C | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 19F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.56 | |
| Confidence Interval |
(2-Sided) 95% 0.40 to 0.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 23F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 4 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.97 | |
| Confidence Interval |
(2-Sided) 95% 1.39 to 2.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 6B | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 3.04 | |
| Confidence Interval |
(2-Sided) 95% 2.41 to 3.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 9V | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.26 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 1.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 14 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 6.66 | |
| Confidence Interval |
(2-Sided) 95% 4.53 to 9.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 18C | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 2.34 | |
| Confidence Interval |
(2-Sided) 95% 1.68 to 3.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 19F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 4.47 | |
| Confidence Interval |
(2-Sided) 95% 3.29 to 6.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 23F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 2.08 | |
| Confidence Interval |
(2-Sided) 95% 1.65 to 2.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | |
| Title | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose |
|---|---|
| Description | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants. |
| Time Frame | Day 1 (36 months after toddler dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity population |
| Arm/Group Title | 7vPnC | 7vPnC and DTaP | DTaP Alone |
|---|---|---|---|
| Arm/Group Description | No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age. | No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age. | No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3). |
| Measure Participants | 123 | 121 | 91 |
| Serotype 4 |
82.9
24.7%
|
64.5
NaN
|
48.8
NaN
|
| Serotype 6B |
100.0
29.9%
|
100.0
NaN
|
97.8
NaN
|
| Serotype 9V |
93.5
27.9%
|
94.2
NaN
|
83.5
NaN
|
| Serotype 14 |
95.1
28.4%
|
91.7
NaN
|
63.7
NaN
|
| Serotype 18C |
81.3
24.3%
|
69.4
NaN
|
45.5
NaN
|
| Serotype 19F |
100.0
29.9%
|
97.5
NaN
|
92.2
NaN
|
| Serotype 23F |
100.0
29.9%
|
99.2
NaN
|
93.4
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 4 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | -18.5 | |
| Confidence Interval |
(2-Sided) 95% -29.4 to -7.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 6B | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -3.1 to 3.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 9V | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% -5.9 to 7.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 14 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | -3.4 | |
| Confidence Interval |
(2-Sided) 95% -10.3 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 18C | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | -11.9 | |
| Confidence Interval |
(2-Sided) 95% -22.7 to -1.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 19F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | -2.5 | |
| Confidence Interval |
(2-Sided) 95% -7.1 to 0.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP |
|---|---|---|
| Comments | Serotype 23F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | -0.8 | |
| Confidence Interval |
(2-Sided) 95% -4.5 to 2.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 4 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 25.0 | |
| Confidence Interval |
(2-Sided) 95% 12.7 to 37.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 6B | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 2.2 | |
| Confidence Interval |
(2-Sided) 95% -0.011 to 7.715 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 9V | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 10.3 | |
| Confidence Interval |
(2-Sided) 95% 1.9 to 19.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 14 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 29.7 | |
| Confidence Interval |
(2-Sided) 95% 19.4 to 40.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 18C | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 30.0 | |
| Confidence Interval |
(2-Sided) 95% 17.9 to 41.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 19F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 6.5 | |
| Confidence Interval |
(2-Sided) 95% 1.2 to 13.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | 7vPnC, 7vPnC and DTaP, DTaP Alone |
|---|---|---|
| Comments | Serotype 23F | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions |
| Estimated Value | 6.2 | |
| Confidence Interval |
(2-Sided) 95% 1.8 to 13.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage. | |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Entire Study Population | |
| Arm/Group Description | All randomized participants | |
All Cause Mortality |
||
| Entire Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Entire Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/335 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Entire Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/335 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer 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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01298544
Other Study ID Numbers:
- B1841009
- 6114A1-4001
First Posted:
Feb 17, 2011
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018