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CompletedNCT00761631Updated Jul 21, 2026Results posted

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

A Phase 3 interventional study of 13 valent pneumococcal conjugate vaccine in Healthy Subjects, sponsored by Pfizer. Completed at 36 sites in United States. Open to participants aged 15 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Non-randomized
Ages
15 Months to 18 Years
Sex
All
01

Study summary

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

02

Conditions studied

  • Healthy Subjects
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
15 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female subjects >15months to \<18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

  • Negative urine pregnancy test for female subjects who are menstruating.

Exclusion criteria

Exclusion Criteria:

  • Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

  • Previous vaccination with Prevnar or any other pneumococcal vaccine.
  • Pregnant or breastfeeding adolescent females.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Masking
None (open label)
Enrollment
1,200 participants (actual)

Study arms

  • Experimental
    Single

    Open label

    Biological: 13 valent pneumococcal conjugate vaccine

Interventions

  • Biological13 valent pneumococcal conjugate vaccine

    Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2

    Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on observed proportion of participants.

    Time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2

  2. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3

    Antibody GMC 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.

    Time frame: 28 to 42 days after dose 1 for Group 3

  3. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4

    Serotype-specific OPA GMTs 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) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.

    Time frame: 28 to 42 days after dose 1 for Group 3 and 4

Other outcomes

  1. Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1

    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).

    Time frame: From the day of dose 1 (Day 1) to Day 7 after dose 1

  2. Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2

    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).

    Time frame: From the day of dose 2 (Day 1) to Day 7 of dose 2

  3. Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1

    Systemic events (any fever \>=38 degrees \[deg\] Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary.

    Time frame: From the day of dose 1 (Day 1) to Day 7 of dose 1

  4. Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2

    Systemic events (any fever \>=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.

    Time frame: From the day of dose 2 (Day 1) to Day 7 of dose 2

07

Results

Posted Aug 10, 2011

Participant flow

Participant flow — Overall Study
Milestone13vPnC Group 1 (Cohort 1)13vPnC Group 2 (Cohort 1)13vPnC Group 1 (Cohort 2)13vPnC Group 2 (Cohort 2)13vPnC Group 313vPnC Group 4
Started126181176119299299
Vaccinated dose 1124179175118294298
Vaccinated dose 21120165000
Completed111174160116277294
Not completed157163225
Withdrew: Parent/legal guardian request838050
Withdrew: Lost to follow-up247161
Withdrew: Protocol violation200151
Withdrew: Randomized, not treated100000
Withdrew: Failed to return101152
Withdrew: Physician decision100000
Withdrew: Other000011

Outcome measures

PrimaryPercentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2

Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on observed proportion of participants.

Time frame:
28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants13vPnC Group 1 (Cohort 1)13vPnC Group 2 (Cohort 1)
Common serotypes - serotype 498.2 (93.5 to 99.8)100.0 (97.9 to 100.0)
Common serotypes - serotype 6B100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Common serotypes - serotype 9V100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Common serotypes - serotype 14100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Common serotypes - serotype 18C100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Common serotypes - serotype 19F100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Common serotypes - serotype 23F99.1 (95.0 to 100.0)100.0 (97.9 to 100.0)
Additional serotypes - serotype 1100.0 (96.7 to 100.0)98.9 (95.9 to 99.9)
Additional serotypes - serotype 394.5 (88.4 to 98.0)92.0 (86.9 to 95.5)
Additional serotypes - serotype 5100.0 (96.7 to 100.0)98.9 (95.9 to 99.9)
Additional serotypes - serotype 6A100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Additional serotypes - serotype 7F100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
Additional serotypes - serotype 19A100.0 (96.7 to 100.0)100.0 (97.9 to 100.0)
PrimaryGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3

Antibody GMC 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.

Time frame:
28 to 42 days after dose 1 for Group 3
Reported as:
Geometric mean · mcg/mL
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
mcg/mL13vPnC Group 3
Common serotypes - serotype 48.45 (7.24 to 9.87)
Common serotypes - serotype 6B53.56 (45.48 to 63.07)
Common serotypes - serotype 9V9.51 (8.38 to 10.78)
Common serotypes - serotype 1429.36 (24.78 to 34.78)
Common serotypes - serotype 18C8.23 (7.13 to 9.51)
Common serotypes - serotype 19F17.58 (14.95 to 20.67)
Common serotypes - serotype 23F11.26 (9.79 to 12.95)
Additional serotypes - serotype 13.57 (3.05 to 4.18)
Additional serotypes - serotype 32.38 (2.07 to 2.74)
Additional serotypes - serotype 55.52 (4.82 to 6.32)
Additional serotypes - serotype 6A21.51 (18.15 to 25.51)
Additional serotypes - serotype 7F6.24 (5.49 to 7.08)
Additional serotypes - serotype 19A17.18 (15.01 to 19.67)
PrimarySerotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4

Serotype-specific OPA GMTs 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) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.

Time frame:
28 to 42 days after dose 1 for Group 3 and 4
Reported as:
Geometric mean · titer
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
titer13vPnC Group 313vPnC Group 4
Common serotypes - serotype 46912 (6101.2 to 7831.4)4629 (4017.2 to 5334.3)
Common serotypes - serotype 6B14224 (12316.4 to 16427.3)14996 (13164.1 to 17083.1)
Common serotypes - serotype 9V4485 (4001.1 to 5027.5)4733 (4203.3 to 5328.4)
Common serotypes - serotype 146894 (6028.3 to 7884.0)4759 (4120.4 to 5497.0)
Common serotypes - serotype 18C6263 (5436.4 to 7215.1)8815 (7738.2 to 10041.0)
Common serotypes - serotype 19F2280 (1949.4 to 2667.6)1559 (1293.3 to 1878.9)
Common serotypes - serotype 23F3808 (3354.7 to 4322.6)3245 (2818.8 to 3735.5)
Additional serotypes - serotype 1319 (271.2 to 376.0)187 (160.4 to 218.6)
Additional serotypes - serotype 3114 (100.4 to 129.4)202 (180.9 to 226.3)
Additional serotypes - serotype 5336 (270.3 to 417.6)491 (426.3 to 565.3)
Additional serotypes - serotype 6A9928 (8457.0 to 11654.8)7514 (6350.8 to 8890.7)
Additional serotypes - serotype 7F6584 (5829.4 to 7435.5)10334 (9099.0 to 11736.8)
Additional serotypes - serotype 19A1276 (1131.7 to 1439.0)1180 (1047.5 to 1329.4)
Statistical analysis
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.5 · 95% CI 1.24 to 1.80
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.9 · 95% CI 0.78 to 1.15
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.9 · 95% CI 0.80 to 1.12
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.4 · 95% CI 1.19 to 1.76
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.7 · 95% CI 0.59 to 0.86
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.5 · 95% CI 1.15 to 1.86
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.2 · 95% CI 0.97 to 1.42
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.7 · 95% CI 1.36 to 2.13
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.6 · 95% CI 0.48 to 0.67
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.7 · 95% CI 0.53 to 0.89
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.3 · 95% CI 1.05 to 1.67
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 0.6 · 95% CI 0.53 to 0.76
  • 13vPnC Group 3 vs 13vPnC Group 4 · Gmt ratio: 1.1 · 95% CI 0.91 to 1.28
Other pre-specifiedPercentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).

Time frame:
From the day of dose 1 (Day 1) to Day 7 after dose 1
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Percentage of participants13vPnC Group 1 (Cohort 1)13vPnC Group 2 (Cohort 1)13vPnC Group 1 (Cohort 2)13vPnC Group 2 (Cohort 2)13vPnC Group 313vPnC Group 4
Tenderness Any (n=108,155, 148,102,265,283)50.961.945.362.786.889.0
Tenderness Significant (n=92,141,133,92,221,242)7.610.65.313.019.543.8
Swelling Any (n=97,144,142,90,226,233)25.822.217.620.037.636.9
Swelling Mild (n=94,143,141,89,220,221)21.320.314.213.521.822.6
Swelling Moderate (n=94,141,135,89,219,226)9.65.77.411.221.921.2
Swelling Severe (n=90,138,131,88,211,214)0.00.00.01.13.31.9
Redness Any (n=103,149,143,91,233,232)39.834.918.936.342.930.2
Redness Mild (n=99,146,143,90,226,226)31.331.516.831.127.921.2
Redness Moderate (n=94,142,135,89,218,221)12.89.95.914.622.014.0
Redness Severe (n=90,138,131,88,212,213)0.00.00.81.13.31.9
Other pre-specifiedPercentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).

Time frame:
From the day of dose 2 (Day 1) to Day 7 of dose 2
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Percentage of participants13vPnC Group 1 (Cohort 1)13vPnC Group 1 (Cohort 2)
Tenderness Any (n=87, 125)57.555.2
Tenderness Significant (n=68, 101)8.89.9
Swelling Any (n=73, 105)23.317.1
Swelling Mild (n=72, 104)22.215.4
Swelling Moderate (n=69, 102)2.97.8
Swelling Severe (n=68, 98)0.00.0
Redness Any (n=76, 110)35.523.6
Redness Mild (n=74, 108)33.818.5
Redness Moderate (n=70, 100)7.16.0
Redness Severe (n=68, 98)0.00.0
Other pre-specifiedPercentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1

Systemic events (any fever \>=38 degrees \[deg\] Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary.

Time frame:
From the day of dose 1 (Day 1) to Day 7 of dose 1
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Percentage of participants13vPnC Group 1 (Cohort 1)13vPnC Group 2 (Cohort 1)13vPnC Group 1 (Cohort 2)13vPnC Group 2 (Cohort 2)13vPnC Group 313vPnC Group 4
Fever >=38 to <=39 degC(n=92,138,137,90,212,214)16.35.117.514.44.25.1
Fever >39 but <=40 degC(n=90,138,130,89,212,212)4.40.74.63.42.40.5
Fever >40 degC (n=90,138,130,88,210,212)0.00.70.01.10.50.5
Decreased appetite (n=99,149,146,94,227,223)42.424.839.734.022.922.9
Irritability (n=108,151,156,102,234,234)60.239.772.452.031.225.2
Increased sleep (n=98,145,146,97,226,229)32.715.937.023.721.226.6
Decreased sleep (n=97,143,140,91,212,224)22.714.032.118.75.718.8
Hives (urticaria) (n=90,139,131,88,213,214)1.10.71.54.51.91.4
Other pre-specifiedPercentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2

Systemic events (any fever \>=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.

Time frame:
From the day of dose 2 (Day 1) to Day 7 of dose 2
Reported as:
Number · Percentage of participants
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Percentage of participants13vPnC Group 1 (Cohort 1)13vPnC Group 1 (Cohort 2)
Fever >=38 but <=39 degC (n=70,101)14.311.9
Fever >39 but <=40 degC (n=68, 100)4.42.0
Fever >40 degC (n=68, 98)0.01.0
Decreased appetite (n=77, 113)40.334.5
Irritability (n=86, 126)65.161.1
Increased sleep (n=75, 109)29.323.9
Decreased sleep (n=77, 112)28.626.8
Hives (urticaria) (n=68, 98)2.90.0

Adverse events

Collected over Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
13vPnC Group 1 (Cohort 1) Dose 1—0/124 (0%)112/124 (90.3%)
13vPnC Group 1 (Cohort 1) Dose 2—2/112 (1.8%)91/112 (81.3%)
13vPnC Group 2 (Cohort 1) Dose 1—1/179 (0.6%)158/179 (88.3%)
13vPnC Group 1 (Cohort 2) Dose 1—1/175 (0.6%)165/175 (94.3%)
13vPnC Group 1 (Cohort 2) Dose 2—4/165 (2.4%)137/165 (83%)
13vPnC Group 2 (Cohort 2) Dose 1—0/118 (0%)107/118 (90.7%)
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)—3/299 (1%)2/299 (0.7%)
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)—1/297 (0.3%)2/297 (0.7%)
13vPnC Group 3—1/294 (0.3%)242/294 (82.3%)
6-Month Follow-up 13vPnC Group 3—0/294 (0%)7/294 (2.4%)
13vPnC Group 4—0/298 (0%)258/298 (86.6%)
6-Month Follow-up 13vPnC Group 4—1/298 (0.3%)4/298 (1.3%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
Event13vPnC Group 1 (Cohort 1) Dose 113vPnC Group 1 (Cohort 1) Dose 213vPnC Group 2 (Cohort 1) Dose 113vPnC Group 1 (Cohort 2) Dose 113vPnC Group 1 (Cohort 2) Dose 213vPnC Group 2 (Cohort 2) Dose 16-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)13vPnC Group 36-Month Follow-up 13vPnC Group 313vPnC Group 46-Month Follow-up 13vPnC Group 4
Gastroenteritis rotavirusInfections and infestations0/1241/1120/1790/1751/1650/1180/2990/2970/2940/2940/2980/298
Respiratory syncytial virus bronchiolitisInfections and infestations0/1241/1120/1790/1750/1650/1180/2990/2970/2940/2940/2980/298
BronchiolitisInfections and infestations0/1240/1120/1790/1751/1650/1180/2990/2970/2940/2940/2980/298
Staphylococcal infectionInfections and infestations0/1240/1120/1790/1751/1650/1180/2990/2970/2940/2940/2980/298
Near drowningInjury, poisoning and procedural complications0/1240/1120/1790/1751/1650/1180/2990/2970/2940/2940/2980/298
AsthmaRespiratory, thoracic and mediastinal disorders0/1240/1120/1791/1750/1650/1180/2990/2970/2940/2940/2981/298
PneumoniaInfections and infestations0/1240/1121/1790/1750/1650/1180/2990/2970/2940/2940/2980/298
WheezingRespiratory, thoracic and mediastinal disorders0/1240/1121/1790/1750/1650/1180/2990/2970/2940/2940/2980/298
AppendicitisInfections and infestations0/1240/1120/1790/1750/1650/1180/2990/2971/2940/2940/2980/298
Status asthmaticusRespiratory, thoracic and mediastinal disorders0/1240/1120/1790/1750/1650/1180/2991/2970/2940/2940/2980/298
Most frequent other events
Showing 10 of 165
Most frequent other events
Event13vPnC Group 1 (Cohort 1) Dose 113vPnC Group 1 (Cohort 1) Dose 213vPnC Group 2 (Cohort 1) Dose 113vPnC Group 1 (Cohort 2) Dose 113vPnC Group 1 (Cohort 2) Dose 213vPnC Group 2 (Cohort 2) Dose 16-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)13vPnC Group 36-Month Follow-up 13vPnC Group 313vPnC Group 46-Month Follow-up 13vPnC Group 4
Tenderness (any)Skin and subcutaneous tissue disorders55/10850/8796/15567/14869/12564/102——230/265—252/283—
IrritabilityGeneral disorders65/10856/8660/151113/15677/12653/102——73/234—59/234—
Tenderness (significant)Skin and subcutaneous tissue disorders7/926/6815/1417/13310/10112/92——43/221—106/242—
Redness (any)Skin and subcutaneous tissue disorders41/10327/7652/14927/14326/11033/91——100/233—70/232—
Decreased appetiteGeneral disorders42/9931/7737/14958/14639/11332/94——52/227—51/223—
Swelling (any)Skin and subcutaneous tissue disorders25/9717/7332/14425/14218/10518/90——85/226—86/233—
Increased sleepGeneral disorders32/9822/7523/14554/14626/10923/97——48/226—61/229—
Redness (mild)Skin and subcutaneous tissue disorders31/9925/7446/14624/14320/10828/90——63/226—48/226—
Decreased sleepGeneral disorders22/9722/7720/14345/14030/11217/91——12/212—42/224—
Swelling (mild)Skin and subcutaneous tissue disorders20/9416/7229/14320/14116/10412/89——48/220—50/221—

Baseline characteristics

Age, Customized
Age, Customized(Participants)13vPnC Group 1 (Cohort 1 and 2)13vPnC Group 2 (Cohort 1 and 2)13vPnC Group 313vPnC Group 4Total
>15 months to <2 years302000302
>=2 years to <5 years030000300
>=5 years to <10 years002990299
>10 years to <18 years000299299
Sex: Female, Male
Sex: Female, Male(Participants)13vPnC Group 1 (Cohort 1 and 2)13vPnC Group 2 (Cohort 1 and 2)13vPnC Group 313vPnC Group 4Total
Female148139155136578
Male154161144163622
08

Study locations

36 sites
  • Central Arkansas Pediatric Clinic
    Benton, Arkansas 72019, United States
  • Northwest Arkansas Pediatric Clinic
    Fayetteville, Arkansas 72703, United States
  • The Children's Clinic of Jonesboro, PA
    Jonesboro, Arkansas 72401, United States
  • Arkansas Pediatric Clinic
    Little Rock, Arkansas 72205, United States
  • Little Rock Children's Clinic, PA
    Little Rock, Arkansas 72205, United States
  • Edinger Medical Group
    Fountain Valley, California 92708, United States
  • Loma Linda University
    Loma Linda, California 92350, United States
  • Loma Linda University
    Loma Linda, California 92354, United States
  • UCLA School of Medicine - Center for Vaccine Research
    Torrance, California 90509, United States
  • USF College of Medicine
    Tampa, Florida 33606, United States
  • Pediatric and Adolescent Medicine, PA
    Marietta, Georgia 30062, United States
  • Pediatric and Adolescent Medicine, PA
    Woodstock, Georgia 30189, United States
  • Northern Illinois Research Associates
    DeKalb, Illinois 60115, United States
  • Pediatric Infectious Diseases
    Louisville, Kentucky 40202-3830, United States
  • Pediatric Infectious Diseases
    Louisville, Kentucky 40202, United States
  • Aspen Medical Group
    Saint Paul, Minnesota 55108, United States
  • Primary Care Pediatric Clinic
    Lebanon, New Hampshire 03756, United States
  • Hunterdon Pediatrics Associates
    Whitehouse Station, New Jersey 08889, United States
  • Elmwood Pediatric Group
    Rochester, New York 14618, United States
  • Cary Pediatric Center
    Cary, North Carolina 27518, United States
  • MedCenter One/ Q&R Clinic
    Bismarck, North Dakota 58501, United States
  • Dakota Clinicl / Innovis Hospital
    Fargo, North Dakota 58103, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45206, United States
  • Shelly Senders & Associates
    Cleveland, Ohio 44121, United States
  • Oklahoma State University Center for Health
    Tulsa, Oklahoma 74127, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Premier Medical Group
    Clarksville, Tennessee 37043, United States
  • University of Texas Medical Branch at Galveston
    Galveston, Texas 77555, United States
  • Southwest Children's Research Associates
    San Antonio, Texas 78229, United States
  • Cottonwood Pediatrics
    Murray, Utah 84107, United States
  • University of Utah, Department of Pediatrics
    Salt Lake City, Utah 84132, United States
  • Families First Pediatrics
    South Jordan, Utah 84095, United States
  • Advanced Pediatrics
    Vienna, Virginia 22180, United States
  • The Vancouver Clinic 700 N.E. 87th Avenue
    Vancouver, Washington 98664, United States
  • The Vancouver Clinic 700 N.E. 87th Avenue
    Vancouver, Washington 98686, United States
  • The Monroe Clinic
    Monroe, Wisconsin 53566, United States
09

References and documents

Publications

  • Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056. PubMed 24136369 ↗
  • Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a. PubMed 21983216 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00761631
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 29, 2008
Start date
Nov 18, 2008
Primary completion
Aug 10, 2010
Completion
Aug 10, 2010
Results posted
Aug 10, 2011
Last update
Jul 21, 2026

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 Mar 2019. You cannot join it, but the record below documents what was studied.

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