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CompletedNCT00689351Updated Jun 28, 2011Results posted

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

A Phase 2 interventional study of 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine in Pneumococcal Vaccine, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 6 sites in Korea, Republic of. Open to participants aged 42 Days to 98 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
42 Days to 98 Days
Sex
All
01

Study summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.

02

Conditions studied

  • Pneumococcal Vaccine

Keywords

  • Prevention
  • against
  • pneumococcal
  • disease
  • Vaccine
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 98 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy 2-month-old-infants (42 to 98 days)
  • Available for the entire study period (14 months)

Exclusion criteria

Exclusion Criteria:

  • Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
  • A previous severe reaction to any vaccine or vaccine-related component
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    1

    13vPnC

    Biological: 13-valent pneumococcal conjugate vaccine

  • Active comparator
    2

    7vPnC

    Biological: 7-valent pneumococcal conjugate vaccine

Interventions

  • Biological13-valent pneumococcal conjugate vaccine

    13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

  • Biological7-valent pneumococcal conjugate vaccine

    7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series

    Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).

    Time frame: 1 month after the infant series (7 months of age)

Secondary outcomes

  1. Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose

    Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.

    Time frame: 1 month after the toddler dose (13 months of age)

Other outcomes

  1. Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series

    Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.

    Time frame: 1 month after the infant series (7 months of age)

  2. Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose

    Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.

    Time frame: 1 month after the Toddler Dose (13 months of age)

  3. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)

    Pre-specified 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 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.

    Time frame: Within 4 days after dose 1 (2 months of age)

  4. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

    Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

    Time frame: Within 4 days after dose 2 (4 months of age)

  5. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

    Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

    Time frame: Within 4 days after dose 3 (6 months of age)

  6. Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)

    Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

    Time frame: Within 4 days after toddler dose (12 months of age)

  7. Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

    Pre-specified 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 (2 months of age)

  8. Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

    Pre-specified 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 (4 months of age)

  9. Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

    Pre-specified 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 (6 months of age)

  10. Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)

    Pre-specified 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)

07

Results

Posted Jan 11, 2011

Participant flow

Infant Series of Dosing
Participant flow — Infant Series of Dosing
Milestone13vPnC7vPnC
Started9189
Vaccinated dose 18889
Vaccinated dose 28688
Vaccinated dose 38588
Completed8588
Not completed61
Withdrew: Parent/legal guardian request50
Withdrew: Adverse event10
Withdrew: Lost to follow-up01
After Infant Series
Participant flow — After Infant Series
Milestone13vPnC7vPnC
Started8588
Completed8488
Not completed10
Withdrew: Parent/legal guardian request10
Toddler Dose
Participant flow — Toddler Dose
Milestone13vPnC7vPnC
Started8488
Completed8488
Not completed00

Outcome measures

PrimaryPercentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).

Time frame:
1 month after the infant series (7 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series
percentage of participants13vPnC7vPnC
Serotype 4100.0 (95.7 to 100.0)100.0 (95.8 to 100.0)
Serotype 6B98.8 (93.5 to 100.0)100.0 (95.8 to 100.0)
Serotype 9V100.0 (95.7 to 100.0)100.0 (95.8 to 100.0)
Serotype 14100.0 (95.7 to 100.0)100.0 (95.7 to 100.0)
Serotype 18C100.0 (95.7 to 100.0)100.0 (95.8 to 100.0)
Serotype 19F97.6 (91.6 to 99.7)98.8 (93.6 to 100.0)
Serotype 23F98.8 (93.5 to 100.0)98.8 (93.6 to 100.0)
Serotype 1100.0 (95.7 to 100.0)2.4 (0.3 to 8.2)
Serotype 3100.0 (95.7 to 100.0)2.4 (0.3 to 8.2)
Serotype 5100.0 (95.7 to 100.0)57.5 (45.9 to 68.5)
Serotype 6A97.6 (91.6 to 99.7)72.3 (61.4 to 81.6)
Serotype 7F100.0 (95.7 to 100.0)4.8 (1.3 to 11.7)
Serotype 19A100.0 (95.7 to 100.0)100.0 (95.6 to 100.0)
SecondaryPercentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose

Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.

Time frame:
1 month after the toddler dose (13 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
percentage of participants13vPnC7vPnC
Serotype 4100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 6B100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 9V100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 1498.7 (93.1 to 100.0)100.0 (95.7 to 100.0)
Serotype 18C100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 19F100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 23F100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Serotype 1100.0 (95.5 to 100.0)1.3 (0.0 to 6.9)
Serotype 3100.0 (95.5 to 100.0)12.0 (5.9 to 21.0)
Serotype 5100.0 (95.5 to 100.0)92.4 (84.2 to 97.2)
Serotype 6A98.8 (93.2 to 100.0)100.0 (95.7 to 100.0)
Serotype 7F100.0 (95.4 to 100.0)23.6 (13.2 to 37.0)
Serotype 19A100.0 (95.5 to 100.0)98.8 (93.5 to 100.0)
Other pre-specifiedGeometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series

Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.

Time frame:
1 month after the infant series (7 months of age)
Reported as:
Geometric mean · Mcg/mL
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
Mcg/mL13vPnC7vPnC
Serotype 45.40 (4.62 to 6.30)6.97 (5.94 to 8.18)
Serotype 6B5.71 (4.64 to 7.03)4.88 (3.96 to 6.01)
Serotype 9V3.33 (2.90 to 3.83)3.78 (3.31 to 4.33)
Serotype 1414.83 (12.38 to 17.77)16.29 (13.36 to 19.85)
Serotype 18C4.57 (3.98 to 5.24)4.73 (4.09 to 5.47)
Serotype 19F3.88 (3.18 to 4.72)4.20 (3.55 to 4.96)
Serotype 23F4.29 (3.56 to 5.16)4.11 (3.40 to 4.98)
Serotype 17.44 (6.25 to 8.85)0.02 (0.02 to 0.03)
Serotype 31.60 (1.35 to 1.89)0.04 (0.03 to 0.05)
Serotype 55.06 (4.37 to 5.85)0.39 (0.30 to 0.49)
Serotype 6A5.73 (4.64 to 7.07)0.64 (0.49 to 0.82)
Serotype 7F6.97 (6.07 to 8.00)0.04 (0.03 to 0.05)
Serotype 19A5.94 (5.13 to 6.89)2.65 (2.29 to 3.06)
Statistical analysis
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.77 · 95% CI 0.62 to 0.97CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 1.17 · 95% CI 0.87 to 1.57CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.88 · 95% CI 0.73 to 1.07CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.91 · 95% CI 0.70 to 1.19CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.97 · 95% CI 0.79 to 1.18CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.92 · 95% CI 0.71 to 1.19CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 1.04 · 95% CI 0.80 to 1.36CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 329.44 · 95% CI 242.98 to 446.67CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 40.79 · 95% CI 30.27 to 54.97CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 13.12 · 95% CI 9.92 to 17.34CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 9.01 · 95% CI 6.46 to 12.56CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 165.90 · 95% CI 122.95 to 223.85CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 2.24 · 95% CI 1.83 to 2.75CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Other pre-specifiedGeometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose

Antibody GMC along with corresponding 2-sided 95% CI 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. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.

Time frame:
1 month after the Toddler Dose (13 months of age)
Reported as:
Geometric mean · Mcg/mL
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
Mcg/mL13vPnC7vPnC
Serotype 46.46 (5.29 to 7.90)8.25 (6.88 to 9.89)
Serotype 6B16.81 (14.36 to 19.68)15.14 (11.91 to 19.25)
Serotype 9V4.59 (3.91 to 5.38)4.83 (4.12 to 5.67)
Serotype 1411.51 (9.59 to 13.80)15.64 (13.07 to 18.72)
Serotype 18C6.86 (5.67 to 8.29)7.44 (6.27 to 8.83)
Serotype 19F7.75 (6.30 to 9.53)5.35 (4.52 to 6.33)
Serotype 23F10.95 (8.77 to 13.66)10.44 (8.60 to 12.68)
Serotype 19.29 (7.65 to 11.28)0.04 (0.03 to 0.05)
Serotype 31.65 (1.40 to 1.95)0.10 (0.08 to 0.13)
Serotype 58.92 (7.62 to 10.45)1.31 (1.09 to 1.56)
Serotype 6A13.58 (11.28 to 16.36)3.33 (2.67 to 4.14)
Serotype 7F11.17 (9.33 to 13.37)0.10 (0.07 to 0.14)
Serotype 19A10.12 (8.55 to 11.98)2.38 (2.04 to 2.78)
Statistical analysis
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.78 · 95% CI 0.60 to 1.02CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 1.11 · 95% CI 0.83 to 1.48CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.95 · 95% CI 0.76 to 1.19CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.74 · 95% CI 0.57 to 0.95CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 0.92 · 95% CI 0.72 to 1.19CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 1.45 · 95% CI 1.11 to 1.88CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 1.05 · 95% CI 0.78 to 1.40CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 234.33 · 95% CI 176.33 to 311.41CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 16.63 · 95% CI 12.19 to 22.69CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 6.84 · 95% CI 5.39 to 8.67CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 4.08 · 95% CI 3.07 to 5.43CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 110.92 · 95% CI 77.09 to 159.59CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
  • 13vPnC vs 7vPnC · Student t distribution · Ratio of geometric means: 4.25 · 95% CI 3.39 to 5.33CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).
Other pre-specifiedPercentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)

Pre-specified 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 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.

Time frame:
Within 4 days after dose 1 (2 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness: Any (n=23,26)31.934.2
Tenderness: Significant (n=6,2)8.82.8
Swelling: Any (n=14,18)19.724.7
Swelling: Mild (n=8,18)11.624.7
Swelling: Moderate (n=7,4)10.15.7
Redness: Any (n=27,22)37.529.3
Redness: Mild (n=23,19)32.925.3
Redness: Moderate (n=4,3)5.84.3
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.862
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.157
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.550
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.052
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.366
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.301
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.362
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.718
Other pre-specifiedPercentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

Time frame:
Within 4 days after dose 2 (4 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness: Any (n=23,24)38.337.5
Tenderness: Significant (n=0,3)0.05.0
Swelling: Any (n=22,18)35.528.6
Swelling: Mild (n=18,15)29.524.6
Swelling: Moderate (n=4,4)7.16.6
Redness: Any (n=20,25)32.838.5
Redness: Mild (n=18,24)29.536.9
Redness: Moderate (n=4,3)7.15.1
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.245
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.447
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.684
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.578
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.451
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.712
Other pre-specifiedPercentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

Time frame:
Within 4 days after dose 3 (6 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness: Any (n=15,16)23.427.1
Tenderness: Significant (n=0,1)0.01.9
Swelling: Any (n=18,14)27.723.3
Swelling: Mild (n=13,13)21.022.0
Swelling: Moderate (n=7,4)11.37.0
Redness: Any (n=19,16)30.226.2
Redness: Mild (n=12,15)20.025.0
Redness: Moderate (n=7,3)11.55.6
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.681
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.482
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.683
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.533
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.692
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.662
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.331
Other pre-specifiedPercentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)

Pre-specified 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 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

Time frame:
Within 4 days after toddler dose (12 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness: Any (n=19,14)33.925.9
Tenderness: Significant (n=3,1)5.92.0
Swelling: Any (n=11,10)22.418.9
Swelling: Mild (n=4,7)8.213.5
Swelling: Moderate (n=9,4)18.47.8
Swelling: Severe (n=1,0)2.00.0
Redness: Any (n=15,12)28.822.2
Redness: Mild (n=9,10)17.618.5
Redness: Moderate (n=8,3)16.06.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.409
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.617
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.807
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.527
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.144
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.495
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.506
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.200
Other pre-specifiedPercentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

Pre-specified 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 (2 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
percentage of participants13vPnC7vPnC
Fever ≥38 degrees C but ≤39 degrees C (n=11,9)15.912.5
Decreased appetite (n=23,22)32.428.9
Irritability (n=38,56)49.470.9
Increased sleep (n=37,30)49.339.0
Decreased sleep (n=28,38)37.850.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.633
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.721
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.009
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.253
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.143
Other pre-specifiedPercentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

Pre-specified 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 (4 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
percentage of participants13vPnC7vPnC
Fever ≥38 degrees C but ≤39 degrees C (n=6,8)10.913.1
Decreased appetite (n=16,28)27.144.4
Irritability (n=25,36)40.353.7
Increased sleep (n=17,16)28.826.2
Decreased sleep (n=18,27)30.040.9
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.781
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.060
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.159
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.839
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.264
Other pre-specifiedPercentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

Pre-specified 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 (6 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
percentage of participants13vPnC7vPnC
Fever ≥38 degrees C but ≤39 degrees C (n=8,5)13.69.3
Fever >39 degrees C but ≤40 degrees C (n=0,1)0.02.0
Decreased appetite (n=14,16)23.028.1
Irritability (n=13,25)21.041.7
Increased sleep (n=18,12)29.521.1
Decreased sleep (n=10,17)16.429.3
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.563
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.468
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.535
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.019
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.398
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.125
Other pre-specifiedPercentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)

Pre-specified 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)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
percentage of participants13vPnC7vPnC
Fever ≥38 degrees C but ≤39 degrees C (n=7,10)13.719.6
Fever >39 degrees C but ≤40 degrees C (n=1,0)2.00.0
Decreased appetite (n=13,15)22.827.8
Irritability (n=18,21)30.537.5
Increased sleep (n=11,8)21.215.4
Decreased sleep (n=11,20)20.434.5
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.596
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.663
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.439
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.613
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.138

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Infant Series 13vPnC—8/88 (9.1%)78/88 (88.6%)
Infant Series 7vPnC—9/89 (10.1%)75/89 (84.3%)
After the Infant Series 13vPnC—9/88 (10.2%)18/88 (20.5%)
After the Infant Series 7vPnC—12/89 (13.5%)19/89 (21.3%)
Toddler Dose 13vPnC—3/84 (3.6%)28/84 (33.3%)
Toddler Dose 7vPnC—3/88 (3.4%)36/88 (40.9%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventInfant Series 13vPnCInfant Series 7vPnCAfter the Infant Series 13vPnCAfter the Infant Series 7vPnCToddler Dose 13vPnCToddler Dose 7vPnC
BronchiolitisInfections and infestations2/884/891/881/890/840/88
PneumoniaInfections and infestations3/881/891/881/891/841/88
GastroenteritisInfections and infestations1/880/893/882/891/840/88
Otitis media acuteInfections and infestations0/880/891/883/890/840/88
Urinary tract infectionInfections and infestations0/882/890/881/890/840/88
BronchitisInfections and infestations1/880/891/881/891/841/88
Inguinal herniaGastrointestinal disorders0/880/891/880/890/840/88
Soft tissue inflammationGeneral disorders0/880/890/880/890/841/88
Kawasaki's diseaseInfections and infestations1/880/890/880/890/840/88
HerpanginaInfections and infestations0/880/891/881/890/840/88
Most frequent other events
Showing 10 of 135
Most frequent other events
EventInfant Series 13vPnCInfant Series 7vPnCAfter the Infant Series 13vPnCAfter the Infant Series 7vPnCToddler Dose 13vPnCToddler Dose 7vPnC
IrritabilityGeneral disorders38/7756/79——18/5921/56
IrritabilityGeneral disorders25/6236/67————
Decreased sleepGeneral disorders28/7438/76——11/5420/58
Increased sleepGeneral disorders37/7530/77——11/528/52
Decreased appetiteGeneral disorders16/5928/63————
IrritabilityGeneral disorders13/6225/60————
Decreased sleepGeneral disorders18/6027/66————
Redness (any)Skin and subcutaneous tissue disorders20/6125/65————
Tenderness (any)Skin and subcutaneous tissue disorders23/6024/64————
Redness (any)Skin and subcutaneous tissue disorders27/7222/75——15/5212/54

Baseline characteristics

Age Continuous
Age Continuous(months)13vPnC7vPnCTotal
Mean2.1 ± 0.32.1 ± 0.22.1 ± 0.2
Sex: Female, Male
Sex: Female, Male(Participants)13vPnC7vPnCTotal
Female453984
Male465096
08

Study locations

6 sites
  • Pfizer Investigational Site
    Incheon, Bupyeong-gu 400-711, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, Jongno-gu 110-744, Korea, Republic of
  • Pfizer Investigational Site
    Incheon, Jung-gu 400-711, Korea, Republic of
  • Pfizer Investigational Site
    Kyunggi, Koyang 412-270, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, Seodaemun-gu 120-752, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, Yeongdeungpo-gu 150-950, Korea, Republic of
09

References and documents

Publications

  • Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6. PubMed 23011012 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00689351
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jun 3, 2008
Start date
Jun 2008
Primary completion
Dec 2009
Completion
Dec 2009
Results posted
Jan 11, 2011
Last update
Jun 28, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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