Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708682
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : February 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Vaccines, Pneumococcal
Intervention Biological: 13-valent pneumococcal conjugate vaccine
Enrollment 225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 13vPnC
Hide 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
Reason Not Completed
Adverse Event             1
Lost to Follow-up             4
Protocol Violation             1
Parent/legal guardian request             6
Failed to return             2
Other             19
Period Title: After Infant Series
Started 192
Completed 191
Not Completed 1
Reason Not Completed
Parent/Legal Guardian Request             1
Period Title: Toddler Dose
Started 191
Completed 183
Not Completed 8
Reason Not Completed
Parent/Legal Guardian Request             1
Lost to Follow-up             3
Failed to Return             4
Arm/Group Title 13vPnC
Hide 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 Number of Baseline Participants 225
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 225 participants
2.1  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants
Female
109
  48.4%
Male
116
  51.6%
1.Primary Outcome
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Common serotypes - serotype 4
100.0
(97.9 to 100.0)
Common serotypes - serotype 6B
97.7
(94.1 to 99.4)
Common serotypes - serotype 9V
98.2
(94.9 to 99.6)
Common serotypes - serotype 14
98.8
(95.8 to 99.9)
Common serotypes - serotype 18C
98.8
(95.8 to 99.9)
Common serotypes - serotype 19F
98.2
(95.0 to 99.6)
Common serotypes - serotype 23F
92.9
(87.9 to 96.3)
Additional serotypes - serotype 1
99.4
(96.8 to 100.0)
Additional serotypes - serotype 3
94.1
(89.4 to 97.1)
Additional serotypes - serotype 5
98.2
(95.0 to 99.6)
Additional serotypes - serotype 6A
98.8
(95.8 to 99.9)
Additional serotypes - serotype 7F
98.8
(95.8 to 99.9)
Additional serotypes - serotype 19A
99.4
(96.8 to 100.0)
2.Secondary Outcome
Title Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 195
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Common serotypes - serotype 4
100.0
(98.1 to 100.0)
Common serotypes - serotype 6B
80.9
(74.7 to 86.2)
Common serotypes - serotype 9V
95.9
(92.1 to 98.2)
Common serotypes - serotype 14
99.0
(96.3 to 99.9)
Common serotypes - serotype 18C
93.3
(88.9 to 96.4)
Common serotypes - serotype 19F
98.5
(95.5 to 99.7)
Common serotypes - serotype 23F
77.9
(71.5 to 83.6)
Additional serotypes - serotype 1
98.5
(95.6 to 99.7)
Additional serotypes - serotype 3
96.4
(92.7 to 98.5)
Additional serotypes - serotype 5
97.4
(94.1 to 99.2)
Additional serotypes - serotype 6A
94.9
(90.8 to 97.5)
Additional serotypes - serotype 7F
99.0
(96.3 to 99.9)
Additional serotypes - serotype 19A
99.5
(97.2 to 100.0)
3.Secondary Outcome
Title Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 155
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Common serotypes - serotype 4
100.0
(97.6 to 100.0)
Common serotypes - serotype 6B
99.4
(96.5 to 100.0)
Common serotypes - serotype 9V
100.0
(97.6 to 100.0)
Common serotypes - serotype 14
100.0
(97.6 to 100.0)
Common serotypes - serotype 18C
100.0
(97.6 to 100.0)
Common serotypes - serotype 19F
100.0
(97.6 to 100.0)
Common serotypes - serotype 23F
99.4
(96.5 to 100.0)
Additional serotypes - serotype 1
100.0
(97.6 to 100.0)
Additional serotypes - serotype 3
96.7
(92.5 to 98.9)
Additional serotypes - serotype 5
100.0
(97.6 to 100.0)
Additional serotypes - serotype 6A
100.0
(97.6 to 100.0)
Additional serotypes - serotype 7F
100.0
(97.6 to 100.0)
Additional serotypes - serotype 19A
100.0
(97.6 to 100.0)
4.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable 2-Dose Infant Immunogenicity population
Arm/Group Title 13vPnC
Hide 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 Number of Participants Analyzed 195
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Common serotypes - serotype 4
3.54
(3.16 to 3.97)
Common serotypes - serotype 6B
0.84
(0.71 to 0.98)
Common serotypes - serotype 9V
1.82
(1.60 to 2.08)
Common serotypes - serotype 14
5.54
(4.72 to 6.50)
Common serotypes - serotype 18C
1.80
(1.56 to 2.07)
Common serotypes - serotype 19F
4.14
(3.59 to 4.78)
Common serotypes - serotype 23F
0.84
(0.71 to 0.99)
Additional serotypes - serotype 1
3.41
(3.00 to 3.89)
Additional serotypes - serotype 3
1.11
(1.01 to 1.23)
Additional serotypes - serotype 5
1.89
(1.67 to 2.13)
Additional serotypes - serotype 6A
1.86
(1.60 to 2.16)
Additional serotypes - serotype 7F
2.98
(2.70 to 3.29)
Additional serotypes - serotype 19A
3.52
(3.07 to 4.03)
5.Other Pre-specified Outcome
Title GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable 3-Dose Infant Immunogenicity population
Arm/Group Title 13vPnC
Hide 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 Number of Participants Analyzed 171
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Common serotypes - serotype 4
3.48
(3.12 to 3.88)
Common serotypes - serotype 6B
5.02
(4.27 to 5.90)
Common serotypes - serotype 9V
2.34
(2.11 to 2.60)
Common serotypes - serotype 14
9.35
(8.07 to 10.82)
Common serotypes - serotype 18C
2.50
(2.23 to 2.81)
Common serotypes - serotype 19F
3.75
(3.28 to 4.29)
Common serotypes - serotype 23F
1.83
(1.55 to 2.17)
Additional serotypes - serotype 1
4.23
(3.73 to 4.79)
Additional serotypes - serotype 3
1.17
(1.03 to 1.33)
Additional serotypes - serotype 5
3.11
(2.75 to 3.52)
Additional serotypes - serotype 6A
4.08
(3.56 to 4.68)
Additional serotypes - serotype 7F
3.71
(3.34 to 4.12)
Additional serotypes - serotype 19A
4.19
(3.71 to 4.74)
6.Other Pre-specified Outcome
Title GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 137
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Common serotypes - serotype 4
5.10
(4.41 to 5.89)
Common serotypes - serotype 6B
15.41
(12.92 to 18.38)
Common serotypes - serotype 9V
3.76
(3.29 to 4.29)
Common serotypes - serotype 14
10.62
(9.16 to 12.32)
Common serotypes - serotype 18C
3.93
(3.45 to 4.48)
Common serotypes - serotype 19F
11.33
(9.68 to 13.26)
Common serotypes - serotype 23F
5.70
(4.81 to 6.77)
Additional serotypes - serotype 1
5.86
(5.08 to 6.75)
Additional serotypes - serotype 3
1.62
(1.42 to 1.84)
Additional serotypes - serotype 5
4.75
(4.18 to 5.40)
Additional serotypes - serotype 6A
11.64
(9.93 to 13.64)
Additional serotypes - serotype 7F
5.81
(5.18 to 6.51)
Additional serotypes - serotype 19A
8.95
(7.84 to 10.23)
7.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 214
Measure Type: Number
Unit of Measure: Percentage of participants
Tenderness: Any 63.5
Tenderness: Significant 12.4
Swelling: Any 31.2
Swelling: Mild 25.1
Swelling: Moderate 11.9
Swelling: Severe 0
Redness: Any 33.8
Redness: Mild 27.9
Redness: Moderate 10.6
Redness: Severe 0
8.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: Percentage of participants
Tenderness: Any 69.4
Tenderness: Significant 12.6
Swelling: Any 29.9
Swelling: Mild 20.0
Swelling: Moderate 13.3
Swelling: Severe 0
Redness: Any 28.9
Redness: Mild 19.5
Redness: Moderate 12.3
Redness: Severe 0
9.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 168
Measure Type: Number
Unit of Measure: Percentage of participants
Tenderness: Any 61.3
Tenderness: Significant 15.4
Swelling: Any 29.4
Swelling: Mild 19.0
Swelling: Moderate 14.6
Swelling: Severe 0
Redness: Any 31.8
Redness: Mild 20.9
Redness: Moderate 13.9
Redness: Severe 0
10.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 154
Measure Type: Number
Unit of Measure: Percentage of participants
Tenderness: Any 43.7
Tenderness: Significant 3.8
Swelling: Any 21.3
Swelling: Mild 8.1
Swelling: Moderate 15.8
Swelling: Severe 0
Redness: Any 22.0
Redness: Mild 8.8
Redness: Moderate 15.7
Redness: Severe 0
11.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 217
Measure Type: Number
Unit of Measure: Percentage of participants
Fever ≥38 degrees C but ≤39 degrees C 7.0
Fever >39 degrees C but ≤40 degrees C 0
Fever >40 degrees C 0
Decreased appetite 31.0
Irritability 69.8
Increased sleep 37.2
Decreased sleep 32.8
12.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 198
Measure Type: Number
Unit of Measure: Percentage of participants
Fever ≥38 degrees C but ≤39 degrees C 18.5
Fever >39 degrees C but ≤40 degrees C 0.6
Fever >40 degrees C 0
Decreased appetite 29.3
Irritability 62.2
Increased sleep 24.5
Decreased sleep 35.1
13.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentage of participants
Fever ≥38 degrees C but ≤39 degrees C 18.3
Fever >39 degrees C but ≤40 degrees C 2.2
Fever >40 degrees C 0
Decreased appetite 25.7
Irritability 63.2
Increased sleep 22.9
Decreased sleep 37.3
14.Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 162
Measure Type: Number
Unit of Measure: Percentage of participants
Fever ≥38 degrees C but ≤39 degrees C 23.0
Fever >39 degrees C but ≤40 degrees C 0
Fever >40 degrees C 0
Decreased appetite 33.8
Irritability 46.7
Increased sleep 17.9
Decreased sleep 22.0
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Infant Series 13vPnC After the Infant Series 13vPnC Toddler Dose 13vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/223 (1.35%)   3/223 (1.35%)   2/191 (1.05%) 
Cardiac disorders       
Myocarditis * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
General disorders       
Pyrexia * 1  1/223 (0.45%)  1/223 (0.45%)  0/191 (0.00%) 
Infections and infestations       
Bronchiolitis * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Pneumonia * 1  0/223 (0.00%)  1/223 (0.45%)  0/191 (0.00%) 
Acute sinusitis * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Nervous system disorders       
Seizure anoxic * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Psychiatric disorders       
Breath holding * 1  0/223 (0.00%)  1/223 (0.45%)  0/191 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Vascular disorders       
Kawasaki's disease * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infant Series 13vPnC After the Infant Series 13vPnC Toddler Dose 13vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   182/223 (81.61%)   3/223 (1.35%)   96/191 (50.26%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Deficiency Anaemia * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  13/223 (5.83%)  0/223 (0.00%)  8/191 (4.19%) 
Gastrooesophageal reflux disease * 1  6/223 (2.69%)  0/223 (0.00%)  0/191 (0.00%) 
Mouth ulceration * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Mucous stools * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Vomiting * 1  0/223 (0.00%)  0/223 (0.00%)  7/191 (3.66%) 
General disorders       
Pyrexia * 1  6/223 (2.69%)  0/223 (0.00%)  14/191 (7.33%) 
Vaccination site pain * 1  0/223 (0.00%)  0/223 (0.00%)  3/191 (1.57%) 
Vaccination site erythema * 1  0/223 (0.00%)  0/223 (0.00%)  2/191 (1.05%) 
Vaccination site swelling * 1  0/223 (0.00%)  0/223 (0.00%)  2/191 (1.05%) 
Irritability * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Fever ≥38°C but ≤39°C  4 [1]  14/199 (7.04%)  0/0  32/139 (23.02%) 
Fever ≥38°C but ≤39°C  4 [2]  33/178 (18.54%)  0/0  0/0 
Fever ≥38°C but ≤39°C  4 [3]  26/142 (18.31%)  0/0  0/0 
Fever >39°C but ≤40°C  4 [4]  0/199 (0.00%)  0/0  0/132 (0.00%) 
Fever >39°C but ≤40°C  4 [5]  1/175 (0.57%)  0/0  0/0 
Fever >39°C but ≤40°C  4 [6]  3/138 (2.17%)  0/0  0/0 
Fever >40°C  4 [7]  0/199 (0.00%)  0/0  0/132 (0.00%) 
Fever >40°C  4 [8]  0/175 (0.00%)  0/0  0/0 
Fever >40°C  4 [9]  0/138 (0.00%)  0/0  0/0 
Decreased appetite  4 [10]  63/203 (31.03%)  0/0  51/151 (33.77%) 
Decreased appetite  4 [11]  55/188 (29.26%)  0/0  0/0 
Decreased appetite  4 [12]  38/148 (25.68%)  0/0  0/0 
Irritability  4 [13]  148/212 (69.81%)  0/0  71/152 (46.71%) 
Irritability  4 [14]  120/193 (62.18%)  0/0  0/0 
Irritability  4 [15]  103/163 (63.19%)  0/0  0/0 
Increased sleep  4 [16]  77/207 (37.20%)  0/0  25/140 (17.86%) 
Increased sleep  4 [17]  45/184 (24.46%)  0/0  0/0 
Increased sleep  4 [18]  35/153 (22.88%)  0/0  0/0 
Decreased sleep  4 [19]  67/204 (32.84%)  0/0  31/141 (21.99%) 
Decreased sleep  4 [20]  66/188 (35.11%)  0/0  0/0 
Decreased sleep  4 [21]  56/150 (37.33%)  0/0  0/0 
Hepatobiliary disorders       
Hepatomegaly * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Immune system disorders       
Allergy to arthropod bite * 1  0/223 (0.00%)  1/223 (0.45%)  0/191 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  33/223 (14.80%)  0/223 (0.00%)  8/191 (4.19%) 
Viral upper respiratory tract infection * 1  11/223 (4.93%)  0/223 (0.00%)  0/191 (0.00%) 
Pharyngitis * 1  7/223 (3.14%)  0/223 (0.00%)  1/191 (0.52%) 
Bronchiolitis * 1  6/223 (2.69%)  0/223 (0.00%)  0/191 (0.00%) 
Viral rhinitis * 1  5/223 (2.24%)  0/223 (0.00%)  0/191 (0.00%) 
Rhinitis * 1  4/223 (1.79%)  0/223 (0.00%)  0/191 (0.00%) 
Viral pharyngitis * 1  4/223 (1.79%)  0/223 (0.00%)  0/191 (0.00%) 
Influenza * 1  3/223 (1.35%)  0/223 (0.00%)  4/191 (2.09%) 
Impetigo * 1  2/223 (0.90%)  0/223 (0.00%)  0/191 (0.00%) 
Acarodermatitis * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Body tinea * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Bronchitis * 1  1/223 (0.45%)  0/223 (0.00%)  2/191 (1.05%) 
Conjunctivitis viral * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Croup infectious * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Cystitis * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Oral candidiasis * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Pyoderma * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Upper respiratory tract infection * 1  1/223 (0.45%)  0/223 (0.00%)  1/191 (0.52%) 
Urinary tract infection * 1  1/223 (0.45%)  0/223 (0.00%)  1/191 (0.52%) 
Acute sinusitis * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Ear infection * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Gastroenteritis * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Pharyngotonsillitis * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Varicella * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Injury, poisoning and procedural complications       
Traumatic brain injury * 1  2/223 (0.90%)  0/223 (0.00%)  0/191 (0.00%) 
Metabolism and nutrition disorders       
Malnutrition * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Decreased appetite * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Nervous system disorders       
Grand mal convulsion * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Cephalhaematoma * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/223 (2.24%)  0/223 (0.00%)  1/191 (0.52%) 
Rhinitis allergic * 1  3/223 (1.35%)  0/223 (0.00%)  0/191 (0.00%) 
Rhinorrhoea * 1  2/223 (0.90%)  0/223 (0.00%)  1/191 (0.52%) 
Bronchospasm * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis diaper * 1  3/223 (1.35%)  0/223 (0.00%)  0/191 (0.00%) 
Rash maculo-papular * 1  3/223 (1.35%)  0/223 (0.00%)  0/191 (0.00%) 
Rash morbilliform * 1  2/223 (0.90%)  0/223 (0.00%)  0/191 (0.00%) 
Seborrhoeic dermatitis * 1  2/223 (0.90%)  2/223 (0.90%)  0/191 (0.00%) 
Dermatitis atopic * 1  1/223 (0.45%)  1/223 (0.45%)  0/191 (0.00%) 
Eczema * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Erythema * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Heat rash * 1  1/223 (0.45%)  0/223 (0.00%)  0/191 (0.00%) 
Dermatitis * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Prurigo * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Urticaria * 1  0/223 (0.00%)  0/223 (0.00%)  1/191 (0.52%) 
Tenderness (any)  2 [22]  134/211 (63.51%)  0/0  66/151 (43.71%) 
Tenderness (any)  3 [23]  136/196 (69.39%)  0/0  0/0 
Tenderness (any)  2 [24]  100/163 (61.35%)  0/0  0/0 
Tenderness (significant)  2 [25]  25/202 (12.38%)  0/0  5/132 (3.79%) 
Tenderness (significant)  2 [26]  23/183 (12.57%)  0/0  0/0 
Tenderness (significant)  2 [27]  22/143 (15.38%)  0/0  0/0 
Swelling (any)  2 [28]  64/205 (31.22%)  0/0  30/141 (21.28%) 
Swelling (any)  2 [29]  56/187 (29.95%)  0/0  0/0 
Swelling (any)  2 [30]  45/153 (29.41%)  0/0  0/0 
Swelling (mild)  2 [31]  51/203 (25.12%)  0/0  11/136 (8.09%) 
Swelling (mild)  2 [32]  37/185 (20.00%)  0/0  0/0 
Swelling (mild)  2 [33]  28/147 (19.05%)  0/0  0/0 
Swelling (moderate)  2 [34]  24/201 (11.94%)  0/0  22/139 (15.83%) 
Swelling (moderate)  2 [35]  24/180 (13.33%)  0/0  0/0 
Swelling (moderate)  2 [36]  21/144 (14.58%)  0/0  0/0 
Swelling (severe)  2 [37]  0/199 (0.00%)  0/0  0/132 (0.00%) 
Swelling (severe)  2 [38]  0/177 (0.00%)  0/0  0/0 
Swelling (severe)  2 [39]  0/138 (0.00%)  0/0  0/0 
Redness (any)  2 [40]  69/204 (33.82%)  0/0  31/141 (21.99%) 
Redness (any)  2 [41]  54/187 (28.88%)  0/0  0/0 
Redness (any)  2 [42]  49/154 (31.82%)  0/0  0/0 
Redness (mild)  2 [43]  57/204 (27.94%)  0/0  12/136 (8.82%) 
Redness (mild)  2 [44]  36/185 (19.46%)  0/0  0/0 
Redness (mild)  2 [45]  31/148 (20.95%)  0/0  0/0 
Redness (moderate)  2 [46]  21/199 (10.55%)  0/0  22/140 (15.71%) 
Redness (moderate)  2 [47]  22/179 (12.29%)  0/0  0/0 
Redness (moderate)  2 [48]  20/144 (13.89%)  0/0  0/0 
Redness (severe)  2 [49]  0/199 (0.00%)  0/0  0/132 (0.00%) 
Redness (severe)  2 [50]  0/177 (0.00%)  0/0  0/0 
Redness (severe)  2 [51]  0/138 (0.00%)  0/0  0/0 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, Local reactions
3
Term from vocabulary, Local reaction
4
Term from vocabulary, Systemic Events
[1]
Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C
[2]
Infant Series Dose 2; Fever ≥38°C but ≤39°C
[3]
Infant Series Dose 3; Fever ≥38°C but ≤39°C
[4]
Infant Series Dose 1 and Toddler Dose; Fever >39°C but ≤40°C
[5]
Infant Series Dose 2; Fever >39°C but ≤40°C
[6]
Infant Series Dose 3; Fever >39°C but ≤40°C
[7]
Infant Series Dose 1 and Toddler Dose; Fever >40°C
[8]
Infant Series Dose 2; Fever >40°C
[9]
Infant Series Dose 3; Fever >40°C
[10]
Infant Series Dose 1 and Toddler Dose; Decreased appetite
[11]
Infant Series Dose 2; Decreased appetite
[12]
Infant Series Dose 3; Decreased appetite
[13]
Infant Series Dose 1 and Toddler Dose; Irritability
[14]
Infant Series Dose 2; Irritability
[15]
Infant Series Dose 3; Irritability
[16]
Infant Series Dose 1 and Toddler Dose; Increased sleep
[17]
Infant Series Dose 2; Increased sleep
[18]
Infant Series Dose 3; Increased sleep
[19]
Infant Series Dose 1 and Toddler Dose; Decreased sleep
[20]
Infant Series Dose 2; Decreased sleep
[21]
Infant Series Dose 3; Decreased sleep
[22]
Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination
[23]
Infant Series Dose 2; tenderness (any)=present at site of vaccination
[24]
Infant Series Dose 3; tenderness (any)=present at site of vaccination
[25]
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement
[26]
Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement
[27]
Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement
[28]
Infant Series Dose 1 and Toddler Dose; swelling (any)=present at site of vaccination
[29]
Infant Series Dose 2; swelling (any)=present at site of vaccination
[30]
Infant Series Dose 3; swelling (any)=present at site of vaccination
[31]
Infant Series Dose 1 and Toddler Dose; swelling (mild)=present at site of vaccination
[32]
Infant Series Dose 2; swelling (mild)=present at site of vaccination
[33]
Infant Series Dose 3; swelling (mild)=present at site of vaccination
[34]
Infant Series Dose 1 and Toddler Dose; swelling (moderate)=present at site of vaccination
[35]
Infant Series Dose 2; swelling (moderate)=present at site of vaccination
[36]
Infant Series Dose 3; swelling (moderate)=present at site of vaccination
[37]
Infant Series Dose 1 and Toddler Dose; swelling (severe)=present at site of vaccination
[38]
Infant Series Dose 2; swelling (severe)=present at site of vaccination
[39]
Infant Series Dose 3; swelling (severe)=present at site of vaccination
[40]
Infant Series Dose 1 and Toddler Dose; redness (any)=present at site of vaccination
[41]
Infant Series Dose 2; redness (any)=present at site of vaccination
[42]
Infant Series Dose 3; redness (any)=present at site of vaccination
[43]
Infant Series Dose 1 and Toddler Dose; redness (mild)=present at site of vaccination
[44]
Infant Series Dose 2; redness (mild)=present at site of vaccination
[45]
Infant Series Dose 3; redness (mild)=present at site of vaccination
[46]
Infant Series Dose 1 and Toddler Dose; redness (moderate)=present at site of vaccination
[47]
Infant Series Dose 2; redness (moderate)=present at site of vaccination
[48]
Infant Series Dose 3; redness (moderate)=present at site of vaccination
[49]
Infant Series Dose 1 and Toddler Dose; redness (severe)=present at site of vaccination
[50]
Infant Series Dose 2; redness (severe)=present at site of vaccination
[51]
Infant Series Dose 3; redness (severe)=present at site of vaccination
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquires@Pfizer.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00708682    
Other Study ID Numbers: 6096A1-3009
First Submitted: June 27, 2008
First Posted: July 2, 2008
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: October 25, 2011