CClinicalTrials.gg
Sign In
CompletedNCT00688870Updated Oct 7, 2022Results posted

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

A Phase 3 interventional study of 13-valent pneumococcal conjugate vaccine (13vPnC) and 7-valent pneumococcal conjugate vaccine (7vPnC) in Vaccines and Pneumococcal Conjugate Vaccine, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 2 sites in Taiwan. Open to participants aged 42 Days to 98 Days. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
168
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 Taiwan.

02

Conditions studied

  • Vaccines
  • Pneumococcal Conjugate Vaccine

Keywords

  • Prevention against pneumococcal disease
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
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    1

    13vPnC

    Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

  • Active comparator
    2

    7vPnC

    Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

Interventions

  • Biological13-valent pneumococcal conjugate vaccine (13vPnC)

    13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

  • Biological7-valent pneumococcal conjugate vaccine (7vPnC)

    7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.

    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (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.

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

Secondary outcomes

  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose

    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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.

    Time frame: 1 month after toddler dose (16 months of age)

Other outcomes

  1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series

    Antibody GMC as measured in mcg/mL 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.

    Time frame: 1 month after the 3-dose infant series (7 months of age)

  2. GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose

    Antibody GMC as measured in mcg/mL 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.

    Time frame: 1 month after the toddler dose (16 months of age)

  3. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (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 and redness present); Mild (0.5 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 1 of the infant series (2 Months of Age)

  4. Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (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 and redness present); Mild (0.5 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 of the infant series (4 months of age)

  5. Percentage of Participants With Pre-specified Local Reactions: Infant Series 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 and redness present); Mild (0.5 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 of the infant series (6 months of age)

  6. Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 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 and redness present); Mild (0.5 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 the toddler dose (15 months of age)

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

    Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, 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 the infant series (2 months of age)

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

    Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, 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 the infant series (4 months of age)

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

    Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, 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 the infant series (6 months of age)

  10. Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).

    Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 4 days after the toddler dose (15 months of age)

07

Results

Posted May 12, 2011
Limitations and caveats
Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.

Participant flow

Subjects were recruited in Taiwan from June 2008 to Nov 2009

Infant Series
Participant flow — Infant Series
Milestone13vPnC7vPnC
Started8484
Vaccinated dose 18384
Vaccinated dose 28084
Vaccinated dose 38084
Completed8084
Not completed40
Withdrew: Parent or legal guardian request40
After Infant Series
Participant flow — After Infant Series
Milestone13vPnC7vPnC
Started8084
Completed8084
Not completed00
Toddler Dose
Participant flow — Toddler Dose
Milestone13vPnC7vPnC
Started8084
Completed8084
Not completed00

Outcome measures

PrimaryPercentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.

Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (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.

Time frame:
1 month after the infant series (7 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 1 Month After the Infant Series.
percentage of participants13vPnC7vPnC
Common Serotypes - Serotype 498.8 (93.2 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 6B100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 9V98.8 (93.2 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 14100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 18C100.0 (95.5 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 19F98.8 (93.2 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 23F95.0 (87.7 to 98.6)100.0 (95.7 to 100.0)
Additional Serotypes - Serotype 198.8 (93.2 to 100.0)2.4 (0.3 to 8.4)
Additional Serotypes - Serotype 397.5 (91.3 to 99.7)2.4 (0.3 to 8.4)
Additional Serotypes - Serotype 598.8 (93.2 to 100.0)61.5 (49.8 to 72.3)
Additional Serotypes - Serotype 6A100.0 (95.5 to 100.0)77.1 (66.6 to 85.6)
Additional Serotypes - Serotype 7F100.0 (95.5 to 100.0)2.4 (0.3 to 8.4)
Additional Serotypes - Serotype 19A100.0 (95.5 to 100.0)100.0 (95.6 to 100.0)
Statistical analysis
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.2 · 95% CI -6.8 to 3.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.2 · 95% CI -6.8 to 3.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.2 · 95% CI -6.8 to 3.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -5.0 · 95% CI -12.3 to -0.3
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 96.3 · 95% CI 89.4 to 99.2
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 95.1 · 95% CI 87.7 to 98.6
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 37.2 · 95% CI 26.2 to 48.9
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 22.9 · 95% CI 14.4 to 33.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 97.6 · 95% CI 91.6 to 99.7
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.5
SecondaryPercentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose

Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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.

Time frame:
1 month after toddler dose (16 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose
percentage of participants13vPnC7vPnC
Common Serotypes - Serotype 498.7 (93.1 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 6B100.0 (95.4 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 9V98.7 (93.1 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 14100.0 (95.4 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 18C100.0 (95.4 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 19F98.7 (93.1 to 100.0)100.0 (95.7 to 100.0)
Common Serotypes - Serotype 23F100.0 (95.4 to 100.0)100.0 (95.7 to 100.0)
Additional Serotypes - Serotype 1100.0 (95.4 to 100.0)5.0 (1.4 to 12.3)
Additional Serotypes - Serotype 396.2 (89.3 to 99.2)13.8 (7.1 to 23.3)
Additional Serotypes - Serotype 5100.0 (95.4 to 100.0)90.4 (81.9 to 95.7)
Additional Serotypes - Serotype 6A100.0 (95.4 to 100.0)100.0 (95.7 to 100.0)
Additional Serotypes - Serotype 7F100.0 (95.4 to 100.0)6.3 (2.1 to 14.0)
Additional Serotypes - Serotype 19A100.0 (95.4 to 100.0)98.8 (93.5 to 100.0)
Statistical analysis
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.3 · 95% CI -6.9 to 3.1
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.3 · 95% CI -6.9 to 3.1
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: -1.3 · 95% CI -6.9 to 3.1
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 95.0 · 95% CI 87.7 to 98.6
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 82.5 · 95% CI 72.0 to 90.1
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 9.6 · 95% CI 3.8 to 18.1
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 0.0 · 95% CI -4.6 to 4.4
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 93.8 · 95% CI 86.0 to 97.9
  • 13vPnC vs 7vPnC · Chan and Zhang · Difference: 1.2 · 95% CI -3.4 to 6.5
Other pre-specifiedGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series

Antibody GMC as measured in mcg/mL 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.

Time frame:
1 month after the 3-dose infant series (7 months of age)
Reported as:
Geometric mean · GMC mcg/mL
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
GMC mcg/mL13vPnC7vPnC
Common serotypes - serotype 42.89 (2.45 to 3.42)4.64 (4.00 to 5.37)
Common serotypes - serotype 6B4.37 (3.58 to 5.33)4.82 (4.09 to 5.67)
Common serotypes - serotype 9V1.97 (1.70 to 2.27)2.92 (2.55 to 3.34)
Common serotypes - serotype 149.76 (8.34 to 11.43)11.59 (9.79 to 13.71)
Common serotypes - serotype 18C2.39 (2.04 to 2.82)3.07 (2.64 to 3.56)
Common serotypes - serotype 19F3.60 (3.00 to 4.32)4.77 (4.17 to 5.47)
Common serotypes - serotype 23F1.93 (1.56 to 2.37)3.25 (2.78 to 3.80)
Additional serotypes - serotype 14.14 (3.45 to 4.96)0.02 (0.02 to 0.02)
Additional serotypes - serotype 31.20 (1.00 to 1.45)0.05 (0.04 to 0.06)
Additional serotypes - serotype 52.47 (2.09 to 2.92)0.43 (0.35 to 0.53)
Additional serotypes - serotype 6A4.57 (3.92 to 5.34)0.79 (0.63 to 0.99)
Additional serotypes - serotype 7F3.67 (3.14 to 4.29)0.04 (0.03 to 0.05)
Additional serotypes - serotype 19A3.69 (3.20 to 4.24)2.46 (2.13 to 2.84)
Statistical analysis
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.62 · 95% CI 0.50 to 0.78Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.91 · 95% CI 0.70 to 1.17Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.67 · 95% CI 0.55 to 0.82Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.84 · 95% CI 0.67 to 1.06Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.78 · 95% CI 0.63 to 0.97Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.75 · 95% CI 0.60 to 0.94Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.59 · 95% CI 0.46 to 0.77Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 202.58 · 95% CI 157.04 to 261.32Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 24.11 · 95% CI 18.46 to 31.49Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 5.69 · 95% CI 4.37 to 7.41Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 5.82 · 95% CI 4.42 to 7.67Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 96.10 · 95% CI 75.60 to 122.17Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 1.50 · 95% CI 1.23 to 1.83Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Other pre-specifiedGMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose

Antibody GMC as measured in mcg/mL 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.

Time frame:
1 month after the toddler dose (16 months of age)
Reported as:
Geometric mean · GMC mcg/mL
GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
GMC mcg/mL13vPnC7vPnC
Common serotypes - serotype 44.06 (3.34 to 4.93)6.34 (5.26 to 7.65)
Common serotypes - serotype 6B13.62 (11.08 to 16.73)13.28 (10.87 to 16.21)
Common serotypes - serotype 9V3.18 (2.66 to 3.80)3.88 (3.27 to 4.60)
Common serotypes - serotype 148.17 (6.53 to 10.22)12.04 (9.90 to 14.63)
Common serotypes - serotype 18C3.67 (3.00 to 4.49)4.87 (4.01 to 5.90)
Common serotypes - serotype 19F8.07 (6.58 to 9.90)7.41 (6.16 to 8.92)
Common serotypes - serotype 23F5.51 (4.46 to 6.81)7.97 (6.55 to 9.68)
Additional serotypes - serotype 17.62 (6.30 to 9.21)0.03 (0.02 to 0.03)
Additional serotypes - serotype 31.29 (1.09 to 1.53)0.12 (0.09 to 0.16)
Additional serotypes - serotype 54.57 (3.87 to 5.39)0.95 (0.80 to 1.13)
Additional serotypes - serotype 6A11.55 (9.66 to 13.81)3.79 (3.01 to 4.76)
Additional serotypes - serotype 7F5.91 (4.95 to 7.06)0.06 (0.04 to 0.07)
Additional serotypes - serotype 19A8.82 (7.45 to 10.43)1.98 (1.69 to 2.32)
Statistical analysis
  • 13vPnC vs 7vPnC · Ratio of gmc: 0.64 · 95% CI 0.49 to 0.84Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 1.03 · 95% CI 0.77 to 1.36Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.82 · 95% CI 0.64 to 1.05Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.68 · 95% CI 0.51 to 0.91Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.75 · 95% CI 0.57 to 0.99Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 1.09 · 95% CI 0.83 to 1.43Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 0.69 · 95% CI 0.52 to 0.92Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 303.73 · 95% CI 213.63 to 431.83Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 10.65 · 95% CI 7.77 to 14.62Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 4.79 · 95% CI 3.78 to 6.08Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 3.05 · 95% CI 2.28 to 4.08Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 105.00 · 95% CI 75.60 to 145.84Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
  • 13vPnC vs 7vPnC · Ratio of gmcs: 4.45 · 95% CI 3.54 to 5.60Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Other pre-specifiedPercentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (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 and redness present); Mild (0.5 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 1 of the infant series (2 Months of Age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
percentage of participants13vPnC7vPnC
Tenderness - Any31.334.2
Tenderness - Significant5.39.3
Swelling - Any25.611.8
Swelling - Mild24.411.8
Swelling - Moderate1.40.0
Swelling - Severe0.00.0
Redness - Any29.928.9
Redness - Mild26.026.3
Redness - Moderate8.12.7
Redness - Severe0.00.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.735
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.533
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.039
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.059
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.275
Other pre-specifiedPercentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (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 and redness present); Mild (0.5 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 of the infant series (4 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness - Any23.622.4
Tenderness - Significant2.91.4
Swelling - Any12.915.3
Swelling - Mild12.915.3
Swelling - Moderate0.00.0
Swelling - Severe0.00.0
Redness - Any17.120.3
Redness - Mild17.117.6
Redness - Moderate0.02.8
Redness - Severe0.00.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.617
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.810
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.810
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.674
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.497
Other pre-specifiedPercentage of Participants With Pre-specified Local Reactions: Infant Series 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 and redness present); Mild (0.5 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 of the infant series (6 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
percentage of participants13vPnC7vPnC
Tenderness - Any19.417.9
Tenderness - Significant0.01.5
Swelling - Any16.94.6
Swelling - Mild15.44.6
Swelling - Moderate3.10.0
Swelling - Severe0.00.0
Redness - Any20.913.8
Redness - Mild18.213.8
Redness - Moderate4.50.0
Redness - Severe0.00.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.044
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.076
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.496
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.361
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.635
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.244
Other pre-specifiedPercentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 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 and redness present); Mild (0.5 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 the toddler dose (15 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
percentage of participants13vPnC7vPnC
Tenderness - Any10.922.7
Tenderness - Significant0.00.0
Swelling - Any7.95.7
Swelling - Mild6.35.7
Swelling - Moderate1.60.0
Swelling - Severe0.00.0
Redness - Any15.412.9
Redness - Mild13.812.9
Redness - Moderate1.60.0
Redness - Severe0.00.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.076
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.735
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.477
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.805
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.477
Other pre-specifiedPercentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

Systemic events (any fever \>=38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, 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 the infant series (2 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
percentage of participants13vPnC7vPnC
Fever >=38 but <=39 degrees C55.050.0
Fever >39 but <=40 degrees C1.41.4
Fever >40 degrees C0.00.0
Decreased appetite50.055.6
Irritability65.070.0
Increased sleep53.250.6
Decreased sleep44.341.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.633
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.527
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.613
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.753
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.748
Other pre-specifiedPercentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, 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 the infant series (4 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
percentage of participants13vPnC7vPnC
Fever >=38 but <=39 degrees C52.143.4
Fever >39 but <=40 degrees C2.92.8
Fever >40 degrees C0.00.0
Decreased appetite50.756.1
Irritability56.057.5
Increased sleep41.143.4
Decreased sleep42.332.5
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.327
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.522
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.872
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.868
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.237
Other pre-specifiedPercentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, 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 the infant series (6 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
percentage of participants13vPnC7vPnC
Fever >=38 but <=39 degrees C31.822.7
Fever >39 but <=40 degrees C4.69.1
Fever >40 degrees C0.01.6
Decreased appetite43.552.0
Irritability42.647.9
Increased sleep40.937.1
Decreased sleep30.933.3
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.329
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.492
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.496
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.322
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.610
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.726
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.855
Other pre-specifiedPercentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).

Systemic events (any fever \>=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 4 days after the toddler dose (15 months of age)
Reported as:
Number · percentage of participants
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
percentage of participants13vPnC7vPnC
Fever >=38 but <=39 degrees C29.221.4
Fever >39 but <=40 degrees C3.24.3
Fever >40 degrees C0.00.0
Decreased appetite27.730.7
Irritability27.727.0
Increased sleep16.716.7
Decreased sleep17.223.0
Statistical analysis
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.326
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.714
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = >0.99
  • 13vPnC vs 7vPnC · Fisher Exact · p = 0.525

Adverse events

Collected over Baseline through 1 month after last study vaccination (16 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=15 months of age.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Infant Series 13vPnC—4/83 (4.8%)81/83 (97.6%)
Infant Series 7vPnC—4/84 (4.8%)77/84 (91.7%)
After the Infant Series 13vPnC—12/83 (14.5%)11/83 (13.3%)
After the Infant Series 7vPnC—9/84 (10.7%)16/84 (19%)
Toddler Dose 13vPnC—0/80 (0%)39/80 (48.8%)
Toddler Dose 7vPnC—3/84 (3.6%)47/84 (56%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventInfant Series 13vPnCInfant Series 7vPnCAfter the Infant Series 13vPnCAfter the Infant Series 7vPnCToddler Dose 13vPnCToddler Dose 7vPnC
GastroenteritisInfections and infestations0/833/842/830/840/801/84
Urinary tract infectionInfections and infestations0/831/841/833/840/800/84
BronchiolitisInfections and infestations1/830/842/832/840/800/84
Otitis media acuteInfections and infestations0/830/842/830/840/800/84
Febrile convulsionNervous system disorders0/830/841/832/840/800/84
IleusGastrointestinal disorders1/830/840/830/840/800/84
BronchopneumoniaInfections and infestations1/831/841/830/840/800/84
Escherichia urinary tract infectionInfections and infestations1/830/841/830/840/800/84
Pneumonia primary atypicalInfections and infestations1/830/840/830/840/800/84
Inguinal herniaGastrointestinal disorders0/830/841/830/840/800/84
Most frequent other events
Showing 10 of 128
Most frequent other events
EventInfant Series 13vPnCInfant Series 7vPnCAfter the Infant Series 13vPnCAfter the Infant Series 7vPnCToddler Dose 13vPnCToddler Dose 7vPnC
IrritabilityGeneral disorders52/8056/80——18/6520/74
Upper respiratory tract infectionInfections and infestations31/8353/840/830/849/808/84
IrritabilityGeneral disorders42/7546/80————
Decreased appetiteGeneral disorders37/7346/82————
Decreased appetiteGeneral disorders39/7845/81——18/6523/75
Fever ≥ 38 degrees C but ≤ 39 degrees CGeneral disorders44/8039/78——19/6515/70
Increased sleepGeneral disorders41/7741/81——11/6612/72
Fever ≥ 38 degrees C but ≤ 39 degrees CGeneral disorders38/7333/76————
Decreased appetiteGeneral disorders30/6939/75————
IrritabilityGeneral disorders29/6834/71————

Baseline characteristics

Age, Continuous
Age, Continuous(months)13vPnC7vPnCTotal
Mean2.2 ± 0.32.3 ± 0.32.2 ± 0.3
Sex: Female, Male
Sex: Female, Male(Participants)13vPnC7vPnCTotal
Female404787
Male443781
Region of Enrollment
Region of Enrollment(Participants)13vPnC7vPnCTotal
Taiwan, Province Of China8484168
08

Study locations

2 sites
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Chang Gung Memorial Hospital - Linko
    Taoyuan Hsien, 333, Taiwan
09

References and documents

Publications

  • Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22. PubMed 22198517 ↗

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00688870
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Responsible party
Sponsor
First posted
Jun 3, 2008
Start date
Jun 5, 2008
Primary completion
Jan 13, 2010
Completion
Jan 13, 2010
Results posted
May 12, 2011
Last update
Oct 7, 2022

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Start the discussion