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CompletedNCT01250756Updated Feb 26, 2013Results posted

A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

A Phase 4 interventional study of 7-pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in Healthy Subjects, sponsored by Pfizer. Completed at 18 sites in Japan. Open to participants aged 3 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-26.

Sponsored by Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
3 Months to 6 Months
Sex
All
01

Study summary

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

02

Conditions studied

  • Healthy Subjects

Keywords

  • vaccine
  • pneumococcal conjugate
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

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

04

Who can participate

Ages eligible
3 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
  • Available for entire study period and whose parent/legal guardian can be reached by telephone.
  • Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion criteria

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
  • Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
321 participants (actual)

Study arms

  • Experimental
    1

    Experimental

    Biological: 7-pneumococcal conjugate vaccine (7vPnC) · Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

  • Experimental
    2

    Active comparator

    Biological: DTaP

Interventions

  • Biological7-pneumococcal conjugate vaccine (7vPnC)

    0.5 mL per dose, 4 doses

  • Biologicaldiphtheria, tetanus, and acellular pertussis vaccine (DTaP)

    0.5 mL per dose, 4 doses

  • BiologicalDTaP

    0.5 mL per dose, 4 doses

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

    Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).

    Time frame: 1 month after the infant series

  2. Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

    Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.

    Time frame: 1 month after the infant series

  3. Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

    Time frame: 1 month after the infant series

  4. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series

    Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

    Time frame: 1 month after the infant series

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

    Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

    Time frame: 1 month after the infant series

Secondary outcomes

  1. Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

    Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.

    Time frame: 1 month after the toddler dose

  2. Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

    GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.

    Time frame: 1 month after the toddler dose

  3. Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

    Time frame: 1 month after the toddler dose

  4. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose

    Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

    Time frame: 1 month after the toddler dose

  5. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

    Time frame: 1 month after the toddler dose

  6. Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

    Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

    Time frame: Pre-toddler dose, 1 month after the toddler dose

  7. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3

    Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

    Time frame: 1 month after the catch-up dose 3

  8. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

    Time frame: 1 month after the catch-up dose 3

Other outcomes

  1. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Dose 1 of the infant series

  2. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Dose 2 of the infant series

  3. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Dose 3 of the infant series

  4. Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after the toddler dose

  5. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Catch-up Dose 1

  6. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Catch-up Dose 2

  7. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

    Time frame: Within 7 days after Catch-up Dose 3

  8. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Dose 1 of the infant series

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

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Dose 2 of the infant series

  10. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Dose 3 of the infant series

  11. Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after the toddler dose

  12. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Catch-up Dose 1

  13. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Catch-up Dose 2

  14. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

    Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

    Time frame: Within 7 days after Catch-up Dose 3

07

Results

Posted Feb 26, 2013

Participant flow

Infant Series
Participant flow — Infant Series
Milestone7vPnC + DTaPDTaP (Catch-up 7vPnC)
Started161160
Vaccinated dose 1159158
Vaccinated dose 2147157
Vaccinated dose 3133155
Completed133153
Not completed287
Withdrew: Withdrawal by subject45
Withdrew: Randomized, not vaccinated22
Withdrew: Other220
After Infant Series
Participant flow — After Infant Series
Milestone7vPnC + DTaPDTaP (Catch-up 7vPnC)
Started133153
Completed122149
Not completed114
Withdrew: Adverse event52
Withdrew: Withdrawal by subject41
Withdrew: Other21
Toddler Dose
Participant flow — Toddler Dose
Milestone7vPnC + DTaPDTaP (Catch-up 7vPnC)
Started122149
Completed122148
Not completed01
Withdrew: Adverse event01
After Toddler Dose
Participant flow — After Toddler Dose
Milestone7vPnC + DTaPDTaP (Catch-up 7vPnC)
Started0148
Completed0147
Not completed01
Withdrew: Adverse event01

Outcome measures

PrimaryPercentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).

Time frame:
1 month after the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Diphtheria100.0 (97.2 to 100.0)100.0 (97.6 to 100.0)
Tetanus100.0 (97.2 to 100.0)100.0 (97.6 to 100.0)
Pertussis toxoid (PT)100.0 (97.2 to 100.0)100.0 (97.6 to 100.0)
Filamentous hemagglutinin (FHA)100.0 (97.2 to 100.0)100.0 (97.6 to 100.0)
PrimaryGeometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.

Time frame:
1 month after the infant series
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
IU/mL7vPnC + DTaPDTaP (Catch-up 7vPnC)
Diphtheria1.38 (1.27 to 1.49)0.99 (0.91 to 1.09)
Tetanus1.91 (1.69 to 2.16)2.05 (1.83 to 2.29)
PrimaryGeometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

Time frame:
1 month after the infant series
Reported as:
Geometric mean · EU/mL
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
EU/mL7vPnC + DTaPDTaP (Catch-up 7vPnC)
Pertussis toxoid (PT)76.79 (70.81 to 83.28)83.56 (77.54 to 90.05)
Filamentous hemagglutinin (FHA)72.89 (65.80 to 80.74)77.85 (71.01 to 85.35)
PrimaryPercentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

Time frame:
1 month after the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants7vPnC + DTaP
4100.0 (97.2 to 100.0)
6B99.2 (95.9 to 100.0)
9V100.0 (97.2 to 100.0)
1499.2 (95.9 to 100.0)
18C99.2 (95.8 to 100.0)
19F97.7 (93.5 to 99.5)
23F98.5 (94.6 to 99.8)
PrimaryGeometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Time frame:
1 month after the infant series
Reported as:
Geometric mean · mcg/mL
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
mcg/mL7vPnC + DTaP
411.82 (10.50 to 13.31)
6B4.23 (3.61 to 4.97)
9V5.96 (5.37 to 6.62)
1416.61 (14.66 to 18.81)
18C5.48 (4.76 to 6.31)
19F8.85 (7.54 to 10.40)
23F4.17 (3.54 to 4.91)
SecondaryPercentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.

Time frame:
1 month after the toddler dose
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Diphtheria100.0 (97.0 to 100.0)100.0 (97.5 to 100.0)
Tetanus100.0 (97.0 to 100.0)100.0 (97.5 to 100.0)
Pertussis toxoid (PT)100.0 (97.0 to 100.0)100.0 (97.5 to 100.0)
Filamentous hemagglutinin (FHA)100.0 (97.0 to 100.0)100.0 (97.5 to 100.0)
SecondaryGeometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.

Time frame:
1 month after the toddler dose
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
IU/mL7vPnC + DTaPDTaP (Catch-up 7vPnC)
Diphtheria2.56 (2.35 to 2.78)2.14 (1.94 to 2.35)
Tetanus2.53 (2.26 to 2.82)3.04 (2.74 to 3.38)
SecondaryGeometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

Time frame:
1 month after the toddler dose
Reported as:
Geometric mean · EU/mL
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
EU/mL7vPnC + DTaPDTaP (Catch-up 7vPnC)
PT106.54 (96.10 to 118.12)130.62 (119.60 to 142.65)
FHA120.99 (109.75 to 133.39)145.38 (132.41 to 159.63)
SecondaryPercentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose

Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

Time frame:
1 month after the toddler dose
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Percentage of participants7vPnC + DTaP
4100.0 (97.0 to 100.0)
6B100.0 (97.0 to 100.0)
9V100.0 (97.0 to 100.0)
14100.0 (97.0 to 100.0)
18C99.2 (95.5 to 100.0)
19F99.2 (95.5 to 100.0)
23F100.0 (97.0 to 100.0)
SecondaryGeometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame:
1 month after the toddler dose
Reported as:
Geometric mean · mcg/mL
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
mcg/mL7vPnC + DTaP
412.15 (10.35 to 14.26)
6B10.66 (8.96 to 12.68)
9V6.43 (5.57 to 7.42)
1415.83 (13.81 to 18.14)
18C6.53 (5.49 to 7.76)
19F9.70 (8.15 to 11.56)
23F10.17 (8.58 to 12.07)
SecondaryGeometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Time frame:
Pre-toddler dose, 1 month after the toddler dose
Reported as:
Geometric mean · Fold Rise
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Fold Rise7vPnC + DTaP
46.74 (5.75 to 7.90)
6B5.89 (5.09 to 6.81)
9V4.34 (3.81 to 4.93)
143.63 (3.22 to 4.09)
18C6.90 (6.06 to 7.85)
19F6.37 (5.35 to 7.59)
23F8.10 (7.01 to 9.35)
SecondaryPercentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3

Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

Time frame:
1 month after the catch-up dose 3
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Percentage of participantsDTaP (Catch-up 7vPnC)
4100.0 (97.5 to 100.0)
6B99.3 (96.3 to 100.0)
9V100.0 (97.5 to 100.0)
14100.0 (97.5 to 100.0)
18C99.3 (96.3 to 100.0)
19F100.0 (97.5 to 100.0)
23F99.3 (96.3 to 100.0)
SecondaryGeometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Time frame:
1 month after the catch-up dose 3
Reported as:
Geometric mean · mcg/mL
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
mcg/mLDTaP (Catch-up 7vPnC)
46.63 (5.91 to 7.44)
6B4.30 (3.75 to 4.93)
9V3.48 (3.12 to 3.89)
1411.55 (10.30 to 12.95)
18C3.10 (2.69 to 3.57)
19F5.16 (4.45 to 5.99)
23F4.41 (3.78 to 5.14)
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Dose 1 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Erythema-Any (n= 152, 152)57.214.5
Erythema-Mild (n= 152, 151)52.612.6
Erythema-Moderate (n= 148, 152)14.92.0
Erythema-Severe (n= 148, 151)0.00.0
Induration-Any (n= 149, 153)40.37.8
Induration-Mild (n= 149, 153)38.37.8
Induration-Moderate (n= 148, 151)10.10.0
Induration-Severe (n= 148, 151)0.00.0
Tenderness-Any (n= 148, 151)12.20.7
Tenderness-Significant (n= 148, 151)0.00.0
Any local reaction (n= 152, 154)66.415.6
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Dose 2 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Erythema-Any (n= 142, 150)64.139.3
Erythema-Mild (n= 142, 150)58.533.3
Erythema-Moderate (n= 134, 147)32.16.8
Erythema-Severe (n= 133, 147)0.00.0
Induration-Any (n= 137, 150)51.830.0
Induration-Mild (n= 137, 150)49.628.7
Induration-Moderate (n= 134, 148)23.96.8
Induration-Severe (n= 133, 147)0.00.0
Tenderness-Any (n= 133, 147)7.54.1
Tenderness-Significant (n= 133, 147)0.00.0
Any local reaction (n= 143, 151)69.245.0
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Dose 3 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Erythema-Any (n= 123, 144)52.830.6
Erythema-Mild (n= 123, 143)46.328.0
Erythema-Moderate (n= 120, 139)20.05.8
Erythema-Severe (n= 118, 138)0.00.0
Induration-Any (n= 124, 144)44.419.4
Induration-Mild (n= 124, 144)42.719.4
Induration-Moderate (n= 119, 139)11.82.2
Induration-Severe (n= 118, 138)0.00.0
Tenderness-Any (n= 119, 138)5.03.6
Tenderness-Significant (n= 118, 138)0.00.0
Any local reaction (n= 126, 145)61.133.1
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after the toddler dose
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Erythema-Any (n= 108, 137)51.932.1
Erythema-Mild (n= 106, 137)48.128.5
Erythema-Moderate (n= 102, 134)23.57.5
Erythema-Severe (n= 98, 133)0.00.0
Induration-Any (n= 108, 137)42.623.4
Induration-Mild (n= 108, 137)40.719.7
Induration-Moderate (n= 99, 133)16.26.8
Induration-Severe (n= 98, 133)0.00.0
Tenderness-Any (n= 99, 136)11.14.4
Tenderness-Significant (n= 98, 133)0.00.0
Any local reaction (n= 110, 138)56.439.1
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Catch-up Dose 1
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Erythema-Any (n= 139)51.8
Erythema-Mild (n= 139)45.3
Erythema-Moderate (n= 136)10.3
Erythema-Severe (n= 135)0.0
Induration-Any (n= 138)34.8
Induration-Mild (n= 138)32.6
Induration-Moderate (n= 135)8.1
Induration-Severe (n= 135)0.0
Tenderness-Any (n= 136)8.1
Tenderness-Significant (n= 135)0.0
Any local reaction (n= 141)54.6
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Catch-up Dose 2
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Erythema-Any (n= 144)50.7
Erythema-Mild (n= 144)45.1
Erythema-Moderate (n= 140)13.6
Erythema-Severe (n= 138)0.0
Induration-Any (n= 144)32.6
Induration-Mild (n= 143)30.1
Induration-Moderate (n= 140)15.0
Induration-Severe (n= 138)0.0
Tenderness-Any (n= 139)5.0
Tenderness-Significant (n= 138)0.0
Any local reaction (n= 145)55.2
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \[cm\]); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

Time frame:
Within 7 days after Catch-up Dose 3
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Erythema-Any (n= 134)32.1
Erythema-Mild (n= 133)27.1
Erythema-Moderate (n= 131)9.9
Erythema-Severe (n= 130)0.0
Induration-Any (n= 134)27.6
Induration-Mild (n= 133)24.8
Induration-Moderate (n= 131)9.9
Induration-Severe (n= 130)0.0
Tenderness-Any (n= 132)6.8
Tenderness-Significant (n= 130)0.0
Any local reaction (n= 137)40.9
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Dose 1 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=149,152)18.815.8
Fever >39 but =<40.0 degrees C(n=148,151)2.02.0
Fever >40 degrees C(n=148,151)0.00.0
Decreased appetite(n=148,151)8.87.9
Irritability(n=151,151)15.29.3
Increased sleep(n=150,153)32.025.5
Decreased sleep(n=151,151)16.615.2
Hives (urticaria)(n=148,151)1.40.7
Antipyretic medication to treat symptom(n=148,151)1.41.3
Any systemic event(n=154,153)57.848.4
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Dose 2 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=138,149)25.415.4
Fever >39 but =<40.0 degrees C(n=135,147)2.20.0
Fever >40 degrees C(n=133,147)0.00.7
Decreased appetite(n=135,147)11.95.4
Irritability(n=134,149)19.412.1
Increased sleep(n=136,148)19.112.8
Decreased sleep(n=140,151)17.115.2
Hives (urticaria)(n=133,147)3.00.0
Antipyretic medication to treat symptom(n=134,147)2.22.0
Any systemic event(n=142,153)53.538.6
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Dose 3 of the infant series
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=120,141)19.214.9
Fever >39 but =<40.0 degrees C(n=118,138)1.70.7
Fever >40 degrees C(n=118,138)0.00.0
Decreased appetite(n=119,138)8.46.5
Irritability(n=118,139)10.27.2
Increased sleep(n=119,141)16.018.4
Decreased sleep(n=120,140)6.714.3
Hives (urticaria)(n=119,138)1.70.0
Antipyretic medication to treat symptom(n=119,138)1.72.2
Any systemic event(n=122,143)39.336.4
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after the toddler dose
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Percentage of participants7vPnC + DTaPDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=103,135)34.022.2
Fever >39 but =<40.0 degrees C(n=99,132)5.12.3
Fever >40 degrees C(n=98,132)1.00.0
Decreased appetite(n=100,133)9.08.3
Irritability(n=100,134)17.09.7
Increased sleep(n=103,135)20.415.6
Decreased sleep(n=101,133)10.97.5
Hives (urticaria)(n=98,133)1.00.8
Antipyretic medication to treat symptom(n=98,133)4.14.5
Any systemic event(n=108,138)52.839.9
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Catch-up Dose 1
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=139)32.4
Fever >39 but =<40.0 degrees C(n=135)2.2
Fever >40 degrees C(n=135)0.0
Decreased appetite(n=136)8.1
Irritability(n=136)12.5
Increased sleep(n=136)17.6
Decreased sleep(n=136)11.8
Hives (urticaria)(n=135)0.7
Antipyretic medication to treat symptom(n=136)5.9
Any systemic event(n=139)49.6
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Catch-up Dose 2
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=140)32.1
Fever >39 but =<40.0 degrees C(n=138)5.1
Fever >40 degrees C(n=138)0.7
Decreased appetite(n=138)10.9
Irritability(n=138)11.6
Increased sleep(n=138)15.9
Decreased sleep(n=139)10.1
Hives (urticaria)(n=138)2.2
Antipyretic medication to treat symptom(n=138)5.1
Any systemic event(n=141)47.5
Other pre-specifiedPercentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

Systemic events (any fever \>= 37.5 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame:
Within 7 days after Catch-up Dose 3
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Percentage of participantsDTaP (Catch-up 7vPnC)
Fever >=37.5 but =<39 degrees C(n=134)26.9
Fever >39 but =<40.0 degrees C(n=130)0.8
Fever >40 degrees C(n=130)0.0
Decreased appetite(n=130)6.2
Irritability(n=131)9.2
Increased sleep(n=131)10.7
Decreased sleep(n=131)6.9
Hives (urticaria)(n=131)0.8
Antipyretic medication to treat symptom(n=130)1.5
Any systemic event(n=136)39.0

Adverse events

Collected over AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
7vPnC + DTaP - Infant Series—3/159 (1.9%)123/159 (77.4%)
DTaP (Catch-up 7vPnC)- Infant Series—7/158 (4.4%)126/158 (79.7%)
7vPnC + DTaP - After the Infant Series—10/159 (6.3%)20/159 (12.6%)
DTaP (Catch-up 7vPnC) - After the Infant Series—7/158 (4.4%)129/158 (81.6%)
7vPnC + DTaP - Toddler Dose—0/122 (0%)72/122 (59%)
DTaP (Catch-up 7vPnC) - Toddler Dose—4/149 (2.7%)96/149 (64.4%)
DTaP (Catch-up 7vPnC) - After the Toddler Dose—1/149 (0.7%)85/149 (57%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
Event7vPnC + DTaP - Infant SeriesDTaP (Catch-up 7vPnC)- Infant Series7vPnC + DTaP - After the Infant SeriesDTaP (Catch-up 7vPnC) - After the Infant Series7vPnC + DTaP - Toddler DoseDTaP (Catch-up 7vPnC) - Toddler DoseDTaP (Catch-up 7vPnC) - After the Toddler Dose
Febrile convulsionNervous system disorders0/1590/1584/1592/1580/1221/1491/149
BronchopneumoniaInfections and infestations0/1590/1580/1590/1580/1222/1490/149
PneumoniaInfections and infestations0/1590/1582/1590/1580/1220/1490/149
Burns second degreeInjury, poisoning and procedural complications0/1590/1580/1590/1580/1221/1490/149
Inguinal herniaGastrointestinal disorders0/1591/1580/1590/1580/1220/1490/149
IntussusceptionGastrointestinal disorders0/1591/1581/1591/1580/1220/1490/149
PyrexiaGeneral disorders0/1591/1580/1590/1580/1220/1490/149
Gastroenteritis viralInfections and infestations1/1591/1581/1590/1580/1220/1490/149
Respiratory syncytial virus bronchitisInfections and infestations1/1591/1580/1590/1580/1220/1490/149
Bronchitis bacterialInfections and infestations0/1591/1580/1590/1580/1220/1490/149
Most frequent other events
Showing 10 of 177
Most frequent other events
Event7vPnC + DTaP - Infant SeriesDTaP (Catch-up 7vPnC)- Infant Series7vPnC + DTaP - After the Infant SeriesDTaP (Catch-up 7vPnC) - After the Infant Series7vPnC + DTaP - Toddler DoseDTaP (Catch-up 7vPnC) - Toddler DoseDTaP (Catch-up 7vPnC) - After the Toddler Dose
Erythema (Any)Skin and subcutaneous tissue disorders91/14259/150—73/144———
Erythema (Mild)Skin and subcutaneous tissue disorders83/14250/150—65/144———
Erythema (Any)Skin and subcutaneous tissue disorders87/15222/152—72/13956/10844/137—
Erythema (Any)Skin and subcutaneous tissue disorders65/12344/144————43/134
Erythema (Mild)Skin and subcutaneous tissue disorders80/15219/151—63/13951/10639/137—
Induration (Any)Skin and subcutaneous tissue disorders71/13745/150—47/144———
Induration (Mild)Skin and subcutaneous tissue disorders68/13743/150—43/143———
Erythema (Mild)Skin and subcutaneous tissue disorders57/12340/143————36/133
Induration (Any)Skin and subcutaneous tissue disorders55/12428/144————37/134
Induration (Mild)Skin and subcutaneous tissue disorders53/12428/144————33/133

Baseline characteristics

Age Continuous
Age Continuous(months)7vPnC + DTaPDTaP (Catch-up 7vPnC)Total
Mean3.8 ± 0.913.9 ± 0.943.9 ± 0.93
Sex: Female, Male
Sex: Female, Male(Participants)7vPnC + DTaPDTaP (Catch-up 7vPnC)Total
Female8082162
Male8178159
08

Study locations

18 sites
  • Sotobo Children's Clinic
    Isumi-city, Chiba, Japan
  • Matsuyama Red Cross Hospital
    Matsuyama-city, Ehime, Japan
  • Yamashita Pediatrics Clinic
    Itoshima, Fukuoka, Japan
  • Yokoyama Children's Clinic
    Kasuga, Fukuoka, Japan
  • Tenshi Hospital
    Sapporo-city, Hokkaido, Japan
  • Furuta Children's Clinic
    Sapporo, Hokkaido, Japan
  • Watanabe Pediatric Allergy Clinic
    Sapporo, Hokkaido, Japan
  • Yamanaka Tatsuru Pediatrics
    Sapporo, Hokkaido, Japan
  • Matsuda Pediatrics Clinic
    Kuwana, Mie, Japan
  • Kawasaki Medical School, Department of Pediatrics
    Kurashiki, Okayama, Japan
  • Momotaro Clinic
    Okayama-city, Okayama, Japan
  • Hug Hug Kids Clinic
    Toyonaka, Osaka, Japan
  • Shibuya Clinic
    Kumagaya-city, Saitama, Japan
  • Tsubaki Children's Clinic
    Chiba, Japan
  • Kiyomatsu Childrens Clinic
    Fukuoka, Japan
  • National Hospital Organization Fukuoka National Hospital
    Fukuoka, Japan
  • Shindo Children's Clinic
    Fukuoka, Japan
  • Takasaki Clinic Pedatrics and Child Health
    Fukuoka, Japan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01250756
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 1, 2010
Start date
Nov 2010
Primary completion
Mar 2012
Completion
Mar 2012
Results posted
Feb 26, 2013
Last update
Feb 26, 2013

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 Jan 2013. You cannot join it, but the record below documents what was studied.

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