Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00708682
Collaborator
(none)
225
9
1
22
25
1.1
Study Details
Study Description
Brief Summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
225 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
Study Start Date
:
Jul 1, 2008
Actual Primary Completion Date
:
May 1, 2010
Actual Study Completion Date
:
May 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Biological: 13-valent pneumococcal conjugate vaccine
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series [1 month after the infant series (7 months of age)]
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Secondary Outcome Measures
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series [1 month after dose 2 of the infant series (5 months of age)]
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose [1 month after the toddler dose (13 months of age)]
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Other Outcome Measures
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series [Dose 2 of infant series (4 months of age)]
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
- GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series [Dose 3 of infant series (6 months of age)]
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
- GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose [Toddler Dose (12 months of age)]
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.
- Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) [Within 4 days after dose 1 of Infant Series (2 months of age)]
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) [Within 4 days after dose 2 of Infant Series (4 months of age)]
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) [Within 4 days after dose 3 (6 months of age)]
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) [Within 4 days after toddler dose (12 months of age)]
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) [Within 4 days after dose 1 of Infant Series (2 months of age)]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) [Within 4 days after dose 2 of Infant Series (4 months of age)]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) [Within 4 days after dose 3 of Infant Series (6 months of age)]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) [Within 4 days after toddler dose (12 months of age)]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Eligibility Criteria
Criteria
Ages Eligible for Study:
42 Days
to 98 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
-
Able to complete three blood draws during study
-
At least 3.5 kg at enrollment
Exclusion Criteria:
-
Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
-
Immune deficiency, bleeding disorder or significant chronic medical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guadalajara | Jalisco | Mexico | 44080 | |
| 2 | Morelia | Michoacan | Mexico | 58070 | |
| 3 | Cuernavaca | Morelos | Mexico | 62508 | |
| 4 | Monterrey | Nuevo Leon | Mexico | 64460 | |
| 5 | Merida | Yucatan | Mexico | 9700 | |
| 6 | Distrio Federal | Mexico | 14080 | ||
| 7 | Distrio Federal | Mexico | 4530 | ||
| 8 | Oaxaca | Mexico | 71220 | ||
| 9 | Puebla | Mexico | 72190 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00708682
Other Study ID Numbers:
- 6096A1-3009
First Posted:
Jul 2, 2008
Last Update Posted:
Oct 25, 2011
Last Verified:
Oct 1, 2011
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Period Title: Infant Series | |
| STARTED | 225 |
| Vaccinated Dose 1 | 223 |
| Vaccinated Dose 2 | 214 |
| Vaccinated Dose 3 | 194 |
| COMPLETED | 192 |
| NOT COMPLETED | 33 |
| Period Title: Infant Series | |
| STARTED | 192 |
| COMPLETED | 191 |
| NOT COMPLETED | 1 |
| Period Title: Infant Series | |
| STARTED | 191 |
| COMPLETED | 183 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Overall Participants | 225 |
| Age (months) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [months] |
2.1
(0.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
109
48.4%
|
| Male |
116
51.6%
|
Outcome Measures
| Title | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series |
|---|---|
| Description | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Time Frame | 1 month after the infant series (7 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 171 |
| Common serotypes - serotype 4 |
100.0
44.4%
|
| Common serotypes - serotype 6B |
97.7
43.4%
|
| Common serotypes - serotype 9V |
98.2
43.6%
|
| Common serotypes - serotype 14 |
98.8
43.9%
|
| Common serotypes - serotype 18C |
98.8
43.9%
|
| Common serotypes - serotype 19F |
98.2
43.6%
|
| Common serotypes - serotype 23F |
92.9
41.3%
|
| Additional serotypes - serotype 1 |
99.4
44.2%
|
| Additional serotypes - serotype 3 |
94.1
41.8%
|
| Additional serotypes - serotype 5 |
98.2
43.6%
|
| Additional serotypes - serotype 6A |
98.8
43.9%
|
| Additional serotypes - serotype 7F |
98.8
43.9%
|
| Additional serotypes - serotype 19A |
99.4
44.2%
|
| Title | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series |
|---|---|
| Description | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Time Frame | 1 month after dose 2 of the infant series (5 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 195 |
| Common serotypes - serotype 4 |
100.0
44.4%
|
| Common serotypes - serotype 6B |
80.9
36%
|
| Common serotypes - serotype 9V |
95.9
42.6%
|
| Common serotypes - serotype 14 |
99.0
44%
|
| Common serotypes - serotype 18C |
93.3
41.5%
|
| Common serotypes - serotype 19F |
98.5
43.8%
|
| Common serotypes - serotype 23F |
77.9
34.6%
|
| Additional serotypes - serotype 1 |
98.5
43.8%
|
| Additional serotypes - serotype 3 |
96.4
42.8%
|
| Additional serotypes - serotype 5 |
97.4
43.3%
|
| Additional serotypes - serotype 6A |
94.9
42.2%
|
| Additional serotypes - serotype 7F |
99.0
44%
|
| Additional serotypes - serotype 19A |
99.5
44.2%
|
| Title | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose |
|---|---|
| Description | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Time Frame | 1 month after the toddler dose (13 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 155 |
| Common serotypes - serotype 4 |
100.0
44.4%
|
| Common serotypes - serotype 6B |
99.4
44.2%
|
| Common serotypes - serotype 9V |
100.0
44.4%
|
| Common serotypes - serotype 14 |
100.0
44.4%
|
| Common serotypes - serotype 18C |
100.0
44.4%
|
| Common serotypes - serotype 19F |
100.0
44.4%
|
| Common serotypes - serotype 23F |
99.4
44.2%
|
| Additional serotypes - serotype 1 |
100.0
44.4%
|
| Additional serotypes - serotype 3 |
96.7
43%
|
| Additional serotypes - serotype 5 |
100.0
44.4%
|
| Additional serotypes - serotype 6A |
100.0
44.4%
|
| Additional serotypes - serotype 7F |
100.0
44.4%
|
| Additional serotypes - serotype 19A |
100.0
44.4%
|
| Title | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series |
|---|---|
| Description | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
| Time Frame | Dose 2 of infant series (4 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable 2-Dose Infant Immunogenicity population |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 195 |
| Common serotypes - serotype 4 |
3.54
|
| Common serotypes - serotype 6B |
0.84
|
| Common serotypes - serotype 9V |
1.82
|
| Common serotypes - serotype 14 |
5.54
|
| Common serotypes - serotype 18C |
1.80
|
| Common serotypes - serotype 19F |
4.14
|
| Common serotypes - serotype 23F |
0.84
|
| Additional serotypes - serotype 1 |
3.41
|
| Additional serotypes - serotype 3 |
1.11
|
| Additional serotypes - serotype 5 |
1.89
|
| Additional serotypes - serotype 6A |
1.86
|
| Additional serotypes - serotype 7F |
2.98
|
| Additional serotypes - serotype 19A |
3.52
|
| Title | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series |
|---|---|
| Description | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
| Time Frame | Dose 3 of infant series (6 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable 3-Dose Infant Immunogenicity population |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 171 |
| Common serotypes - serotype 4 |
3.48
|
| Common serotypes - serotype 6B |
5.02
|
| Common serotypes - serotype 9V |
2.34
|
| Common serotypes - serotype 14 |
9.35
|
| Common serotypes - serotype 18C |
2.50
|
| Common serotypes - serotype 19F |
3.75
|
| Common serotypes - serotype 23F |
1.83
|
| Additional serotypes - serotype 1 |
4.23
|
| Additional serotypes - serotype 3 |
1.17
|
| Additional serotypes - serotype 5 |
3.11
|
| Additional serotypes - serotype 6A |
4.08
|
| Additional serotypes - serotype 7F |
3.71
|
| Additional serotypes - serotype 19A |
4.19
|
| Title | GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose |
|---|---|
| Description | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series. |
| Time Frame | Toddler Dose (12 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 137 |
| Common serotypes - serotype 4 |
5.10
|
| Common serotypes - serotype 6B |
15.41
|
| Common serotypes - serotype 9V |
3.76
|
| Common serotypes - serotype 14 |
10.62
|
| Common serotypes - serotype 18C |
3.93
|
| Common serotypes - serotype 19F |
11.33
|
| Common serotypes - serotype 23F |
5.70
|
| Additional serotypes - serotype 1 |
5.86
|
| Additional serotypes - serotype 3 |
1.62
|
| Additional serotypes - serotype 5 |
4.75
|
| Additional serotypes - serotype 6A |
11.64
|
| Additional serotypes - serotype 7F |
5.81
|
| Additional serotypes - serotype 19A |
8.95
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) |
|---|---|
| Description | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 1 of Infant Series (2 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 214 |
| Tenderness: Any |
63.5
28.2%
|
| Tenderness: Significant |
12.4
5.5%
|
| Swelling: Any |
31.2
13.9%
|
| Swelling: Mild |
25.1
11.2%
|
| Swelling: Moderate |
11.9
5.3%
|
| Swelling: Severe |
0
0%
|
| Redness: Any |
33.8
15%
|
| Redness: Mild |
27.9
12.4%
|
| Redness: Moderate |
10.6
4.7%
|
| Redness: Severe |
0
0%
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) |
|---|---|
| Description | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 2 of Infant Series (4 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 196 |
| Tenderness: Any |
69.4
30.8%
|
| Tenderness: Significant |
12.6
5.6%
|
| Swelling: Any |
29.9
13.3%
|
| Swelling: Mild |
20.0
8.9%
|
| Swelling: Moderate |
13.3
5.9%
|
| Swelling: Severe |
0
0%
|
| Redness: Any |
28.9
12.8%
|
| Redness: Mild |
19.5
8.7%
|
| Redness: Moderate |
12.3
5.5%
|
| Redness: Severe |
0
0%
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) |
|---|---|
| Description | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 3 (6 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 168 |
| Tenderness: Any |
61.3
27.2%
|
| Tenderness: Significant |
15.4
6.8%
|
| Swelling: Any |
29.4
13.1%
|
| Swelling: Mild |
19.0
8.4%
|
| Swelling: Moderate |
14.6
6.5%
|
| Swelling: Severe |
0
0%
|
| Redness: Any |
31.8
14.1%
|
| Redness: Mild |
20.9
9.3%
|
| Redness: Moderate |
13.9
6.2%
|
| Redness: Severe |
0
0%
|
| Title | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) |
|---|---|
| Description | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after toddler dose (12 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 154 |
| Tenderness: Any |
43.7
19.4%
|
| Tenderness: Significant |
3.8
1.7%
|
| Swelling: Any |
21.3
9.5%
|
| Swelling: Mild |
8.1
3.6%
|
| Swelling: Moderate |
15.8
7%
|
| Swelling: Severe |
0
0%
|
| Redness: Any |
22.0
9.8%
|
| Redness: Mild |
8.8
3.9%
|
| Redness: Moderate |
15.7
7%
|
| Redness: Severe |
0
0%
|
| Title | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) |
|---|---|
| Description | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 1 of Infant Series (2 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 217 |
| Fever ≥38 degrees C but ≤39 degrees C |
7.0
3.1%
|
| Fever >39 degrees C but ≤40 degrees C |
0
0%
|
| Fever >40 degrees C |
0
0%
|
| Decreased appetite |
31.0
13.8%
|
| Irritability |
69.8
31%
|
| Increased sleep |
37.2
16.5%
|
| Decreased sleep |
32.8
14.6%
|
| Title | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) |
|---|---|
| Description | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 2 of Infant Series (4 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 198 |
| Fever ≥38 degrees C but ≤39 degrees C |
18.5
8.2%
|
| Fever >39 degrees C but ≤40 degrees C |
0.6
0.3%
|
| Fever >40 degrees C |
0
0%
|
| Decreased appetite |
29.3
13%
|
| Irritability |
62.2
27.6%
|
| Increased sleep |
24.5
10.9%
|
| Decreased sleep |
35.1
15.6%
|
| Title | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) |
|---|---|
| Description | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after dose 3 of Infant Series (6 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 172 |
| Fever ≥38 degrees C but ≤39 degrees C |
18.3
8.1%
|
| Fever >39 degrees C but ≤40 degrees C |
2.2
1%
|
| Fever >40 degrees C |
0
0%
|
| Decreased appetite |
25.7
11.4%
|
| Irritability |
63.2
28.1%
|
| Increased sleep |
22.9
10.2%
|
| Decreased sleep |
37.3
16.6%
|
| Title | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) |
|---|---|
| Description | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Time Frame | Within 4 days after toddler dose (12 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. |
| Arm/Group Title | 13vPnC |
|---|---|
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose) |
| Measure Participants | 162 |
| Fever ≥38 degrees C but ≤39 degrees C |
23.0
10.2%
|
| Fever >39 degrees C but ≤40 degrees C |
0
0%
|
| Fever >40 degrees C |
0
0%
|
| Decreased appetite |
33.8
15%
|
| Irritability |
46.7
20.8%
|
| Increased sleep |
17.9
8%
|
| Decreased sleep |
22.0
9.8%
|
Adverse Events
| Time Frame | Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||
| Arm/Group Title | Infant Series 13vPnC | After the Infant Series 13vPnC | Toddler Dose 13vPnC | |||
| Arm/Group Description | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series). Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively. | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age). | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96. | |||
All Cause Mortality |
||||||
| Infant Series 13vPnC | After the Infant Series 13vPnC | Toddler Dose 13vPnC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Infant Series 13vPnC | After the Infant Series 13vPnC | Toddler Dose 13vPnC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/223 (1.3%) | 3/223 (1.3%) | 2/191 (1%) | |||
| Cardiac disorders | ||||||
| Myocarditis | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| General disorders | ||||||
| Pyrexia | 1/223 (0.4%) | 1/223 (0.4%) | 0/191 (0%) | |||
| Infections and infestations | ||||||
| Bronchiolitis | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Pneumonia | 0/223 (0%) | 1/223 (0.4%) | 0/191 (0%) | |||
| Acute sinusitis | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Nervous system disorders | ||||||
| Seizure anoxic | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Psychiatric disorders | ||||||
| Breath holding | 0/223 (0%) | 1/223 (0.4%) | 0/191 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Vascular disorders | ||||||
| Kawasaki's disease | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Infant Series 13vPnC | After the Infant Series 13vPnC | Toddler Dose 13vPnC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 182/223 (81.6%) | 3/223 (1.3%) | 96/191 (50.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Deficiency Anaemia | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 13/223 (5.8%) | 0/223 (0%) | 8/191 (4.2%) | |||
| Gastrooesophageal reflux disease | 6/223 (2.7%) | 0/223 (0%) | 0/191 (0%) | |||
| Mouth ulceration | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Mucous stools | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Vomiting | 0/223 (0%) | 0/223 (0%) | 7/191 (3.7%) | |||
| General disorders | ||||||
| Pyrexia | 6/223 (2.7%) | 0/223 (0%) | 14/191 (7.3%) | |||
| Vaccination site pain | 0/223 (0%) | 0/223 (0%) | 3/191 (1.6%) | |||
| Vaccination site erythema | 0/223 (0%) | 0/223 (0%) | 2/191 (1%) | |||
| Vaccination site swelling | 0/223 (0%) | 0/223 (0%) | 2/191 (1%) | |||
| Irritability | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Fever ≥38°C but ≤39°C | 14/199 (7%) | 0/0 (NaN) | 32/139 (23%) | |||
| Fever ≥38°C but ≤39°C | 33/178 (18.5%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Fever ≥38°C but ≤39°C | 26/142 (18.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Fever >39°C but ≤40°C | 0/199 (0%) | 0/0 (NaN) | 0/132 (0%) | |||
| Fever >39°C but ≤40°C | 1/175 (0.6%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Fever >39°C but ≤40°C | 3/138 (2.2%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Fever >40°C | 0/199 (0%) | 0/0 (NaN) | 0/132 (0%) | |||
| Fever >40°C | 0/175 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Fever >40°C | 0/138 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Decreased appetite | 63/203 (31%) | 0/0 (NaN) | 51/151 (33.8%) | |||
| Decreased appetite | 55/188 (29.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Decreased appetite | 38/148 (25.7%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Irritability | 148/212 (69.8%) | 0/0 (NaN) | 71/152 (46.7%) | |||
| Irritability | 120/193 (62.2%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Irritability | 103/163 (63.2%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Increased sleep | 77/207 (37.2%) | 0/0 (NaN) | 25/140 (17.9%) | |||
| Increased sleep | 45/184 (24.5%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Increased sleep | 35/153 (22.9%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Decreased sleep | 67/204 (32.8%) | 0/0 (NaN) | 31/141 (22%) | |||
| Decreased sleep | 66/188 (35.1%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Decreased sleep | 56/150 (37.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Hepatobiliary disorders | ||||||
| Hepatomegaly | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Immune system disorders | ||||||
| Allergy to arthropod bite | 0/223 (0%) | 1/223 (0.4%) | 0/191 (0%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 33/223 (14.8%) | 0/223 (0%) | 8/191 (4.2%) | |||
| Viral upper respiratory tract infection | 11/223 (4.9%) | 0/223 (0%) | 0/191 (0%) | |||
| Pharyngitis | 7/223 (3.1%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Bronchiolitis | 6/223 (2.7%) | 0/223 (0%) | 0/191 (0%) | |||
| Viral rhinitis | 5/223 (2.2%) | 0/223 (0%) | 0/191 (0%) | |||
| Rhinitis | 4/223 (1.8%) | 0/223 (0%) | 0/191 (0%) | |||
| Viral pharyngitis | 4/223 (1.8%) | 0/223 (0%) | 0/191 (0%) | |||
| Influenza | 3/223 (1.3%) | 0/223 (0%) | 4/191 (2.1%) | |||
| Impetigo | 2/223 (0.9%) | 0/223 (0%) | 0/191 (0%) | |||
| Acarodermatitis | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Body tinea | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Bronchitis | 1/223 (0.4%) | 0/223 (0%) | 2/191 (1%) | |||
| Conjunctivitis viral | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Croup infectious | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Cystitis | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Oral candidiasis | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Pyoderma | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Upper respiratory tract infection | 1/223 (0.4%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Urinary tract infection | 1/223 (0.4%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Acute sinusitis | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Ear infection | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Gastroenteritis | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Pharyngotonsillitis | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Varicella | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Injury, poisoning and procedural complications | ||||||
| Traumatic brain injury | 2/223 (0.9%) | 0/223 (0%) | 0/191 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Malnutrition | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Decreased appetite | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Nervous system disorders | ||||||
| Grand mal convulsion | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| Cephalhaematoma | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 5/223 (2.2%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Rhinitis allergic | 3/223 (1.3%) | 0/223 (0%) | 0/191 (0%) | |||
| Rhinorrhoea | 2/223 (0.9%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Bronchospasm | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis diaper | 3/223 (1.3%) | 0/223 (0%) | 0/191 (0%) | |||
| Rash maculo-papular | 3/223 (1.3%) | 0/223 (0%) | 0/191 (0%) | |||
| Rash morbilliform | 2/223 (0.9%) | 0/223 (0%) | 0/191 (0%) | |||
| Seborrhoeic dermatitis | 2/223 (0.9%) | 2/223 (0.9%) | 0/191 (0%) | |||
| Dermatitis atopic | 1/223 (0.4%) | 1/223 (0.4%) | 0/191 (0%) | |||
| Eczema | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Erythema | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Heat rash | 1/223 (0.4%) | 0/223 (0%) | 0/191 (0%) | |||
| Dermatitis | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Prurigo | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Urticaria | 0/223 (0%) | 0/223 (0%) | 1/191 (0.5%) | |||
| Tenderness (any) | 134/211 (63.5%) | 0/0 (NaN) | 66/151 (43.7%) | |||
| Tenderness (any) | 136/196 (69.4%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Tenderness (any) | 100/163 (61.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Tenderness (significant) | 25/202 (12.4%) | 0/0 (NaN) | 5/132 (3.8%) | |||
| Tenderness (significant) | 23/183 (12.6%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Tenderness (significant) | 22/143 (15.4%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (any) | 64/205 (31.2%) | 0/0 (NaN) | 30/141 (21.3%) | |||
| Swelling (any) | 56/187 (29.9%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (any) | 45/153 (29.4%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (mild) | 51/203 (25.1%) | 0/0 (NaN) | 11/136 (8.1%) | |||
| Swelling (mild) | 37/185 (20%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (mild) | 28/147 (19%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (moderate) | 24/201 (11.9%) | 0/0 (NaN) | 22/139 (15.8%) | |||
| Swelling (moderate) | 24/180 (13.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (moderate) | 21/144 (14.6%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (severe) | 0/199 (0%) | 0/0 (NaN) | 0/132 (0%) | |||
| Swelling (severe) | 0/177 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Swelling (severe) | 0/138 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (any) | 69/204 (33.8%) | 0/0 (NaN) | 31/141 (22%) | |||
| Redness (any) | 54/187 (28.9%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (any) | 49/154 (31.8%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (mild) | 57/204 (27.9%) | 0/0 (NaN) | 12/136 (8.8%) | |||
| Redness (mild) | 36/185 (19.5%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (mild) | 31/148 (20.9%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (moderate) | 21/199 (10.6%) | 0/0 (NaN) | 22/140 (15.7%) | |||
| Redness (moderate) | 22/179 (12.3%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (moderate) | 20/144 (13.9%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (severe) | 0/199 (0%) | 0/0 (NaN) | 0/132 (0%) | |||
| Redness (severe) | 0/177 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
| Redness (severe) | 0/138 (0%) | 0/0 (NaN) | 0/0 (NaN) | |||
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 Clinical Trials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquires@Pfizer.com |
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00708682
Other Study ID Numbers:
- 6096A1-3009
First Posted:
Jul 2, 2008
Last Update Posted:
Oct 25, 2011
Last Verified:
Oct 1, 2011