A Phase 3 interventional study of 13vPnC and 13vPnC in Pneumococcal Vaccines, sponsored by Pfizer. Completed at 7 sites in Sweden. Open to participants aged 140 Days to 392 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-10.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
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Exclusion Criteria:
Biological: 13vPnC
Biological: 13vPnC
13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
13vPnC will be administered by intramuscular injection at approximately 12 months of age.
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time frame: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time frame: 12 months of age (prior to toddler dose)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (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). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
Time frame: Day 1 through Day 7 after vaccination
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 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 or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
Time frame: Day 1 through Day 7 after vaccination
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time frame: Day 1 through 7 after vaccination
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time frame: Day 1 through 7 after vaccination
| Milestone | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Started | 118 | 0 |
| Completed | 118 | 0 |
| Not completed | 0 | 0 |
| Milestone | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Started | 118 | 0 |
| Completed | 118 | 0 |
| Not completed | 0 | 0 |
| Milestone | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Started | 118 | 116 |
| Completed | 116 | 116 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Parent/legal guardian request | 1 | 0 |
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
| mcg/mL | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Common Serotype 4 | 5.27 (4.43 to 6.26) | 5.06 (4.22 to 6.06) |
| Common Serotype 6B | 9.63 (8.01 to 11.57) | 8.75 (6.76 to 11.32) |
| Common Serotype 9V | 3.50 (3.01 to 4.07) | 3.33 (2.88 to 3.84) |
| Common Serotype 14 | 9.22 (7.66 to 11.09) | 9.30 (7.90 to 10.95) |
| Common Serotype 18C | 2.93 (2.50 to 3.44) | 3.87 (3.30 to 4.53) |
| Common Serotype 19F | 7.70 (6.12 to 9.69) | 8.31 (6.39 to 10.81) |
| Common Serotype 23F | 3.27 (2.68 to 3.99) | 4.40 (3.70 to 5.22) |
| Additional Serotype 1 | 14.65 (12.50 to 17.17) | 1.58 (1.30 to 1.93) |
| Additional Serotype 3 | 1.85 (1.59 to 2.15) | 1.34 (1.13 to 1.58) |
| Additional Serotype 5 | 7.02 (5.98 to 8.25) | 1.44 (1.21 to 1.72) |
| Additional Serotype 6A | 6.14 (5.08 to 7.43) | 2.48 (1.89 to 3.26) |
| Additional Serotype 7F | 5.86 (5.11 to 6.72) | 3.55 (3.09 to 4.08) |
| Additional Serotype 19A | 7.25 (6.14 to 8.57) | 13.16 (11.26 to 15.38) |
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
| Percentage of participants | 13vPnC/13vPnC |
|---|---|
| Common Serotype 4 | 99.1 (95.3 to 100.0) |
| Common Serotype 6B | 53.0 (43.5 to 62.4) |
| Common Serotype 9V | 99.1 (95.3 to 100.0) |
| Common Serotype 14 | 96.5 (91.3 to 99.0) |
| Common Serotype 18C | 95.7 (90.1 to 98.6) |
| Common Serotype 19F | 92.2 (85.7 to 96.4) |
| Common Serotype 23F | 62.6 (53.1 to 71.5) |
| Additional Serotype 1 | 80.9 (72.5 to 87.6) |
| Additional Serotype 3 | 100.0 (96.8 to 100.0) |
| Additional Serotype 5 | 83.5 (75.4 to 89.7) |
| Additional Serotype 6A | 36.8 (28.0 to 46.4) |
| Additional Serotype 7F | 93.0 (86.8 to 96.9) |
| Additional Serotype 19A | 87.8 (80.4 to 93.2) |
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
| mcg/mL | 13vPnC/13vPnC |
|---|---|
| Common Serotype 4 | 2.90 (2.48 to 3.40) |
| Common Serotype 6B | 0.40 (0.32 to 0.50) |
| Common Serotype 9V | 1.73 (1.50 to 1.99) |
| Common Serotype 14 | 4.70 (3.72 to 5.92) |
| Common Serotype 18C | 1.56 (1.29 to 1.89) |
| Common Serotype 19F | 3.01 (2.34 to 3.88) |
| Common Serotype 23F | 0.57 (0.46 to 0.70) |
| Additional Serotype 1 | 0.89 (0.73 to 1.08) |
| Additional Serotype 3 | 1.88 (1.65 to 2.14) |
| Additional Serotype 5 | 0.72 (0.62 to 0.84) |
| Additional Serotype 6A | 0.28 (0.23 to 0.34) |
| Additional Serotype 7F | 1.78 (1.48 to 2.15) |
| Additional Serotype 19A | 0.85 (0.73 to 0.99) |
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.
| mcg/mL | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Common Serotype 4 | 0.66 (0.57 to 0.77) | 0.62 (0.53 to 0.72) |
| Common Serotype 6B | 0.83 (0.67 to 1.02) | 0.65 (0.51 to 0.82) |
| Common Serotype 9V | 0.74 (0.65 to 0.85) | 0.70 (0.60 to 0.82) |
| Common Serotype 14 | 1.99 (1.63 to 2.42) | 2.23 (1.85 to 2.69) |
| Common Serotype 18C | 0.35 (0.30 to 0.41) | 0.44 (0.38 to 0.51) |
| Common Serotype 19F | 0.85 (0.70 to 1.03) | 0.81 (0.66 to 1.00) |
| Common Serotype 23F | 0.33 (0.27 to 0.39) | 0.41 (0.34 to 0.49) |
| Additional Serotype 1 | 0.46 (0.40 to 0.53) | 0.01 (0.01 to 0.02) |
| Additional Serotype 3 | 0.40 (0.34 to 0.47) | 0.05 (0.04 to 0.07) |
| Additional Serotype 5 | 1.18 (1.02 to 1.36) | 0.33 (0.26 to 0.42) |
| Additional Serotype 6A | 0.71 (0.60 to 0.85) | 0.24 (0.19 to 0.31) |
| Additional Serotype 7F | 1.08 (0.95 to 1.23) | 0.02 (0.02 to 0.02) |
| Additional Serotype 19A | 1.06 (0.88 to 1.28) | 1.55 (1.32 to 1.81) |
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
| Percentage of participants | 13vPnC/13vPnC |
|---|---|
| Tenderness: Any (n=108) | 36.1 |
| Tenderness: Significant (n=99) | 3.0 |
| Swelling: Any (n=104) | 33.7 |
| Swelling: Mild (n=104) | 31.7 |
| Swelling: Moderate (n=101) | 9.9 |
| Swelling: Severe (n=99) | 0.0 |
| Redness: Any (n=107) | 40.2 |
| Redness: Mild (n=107) | 36.4 |
| Redness: Moderate (n=99) | 4.0 |
| Redness: Severe (n=99) | 0.0 |
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.
| Percentage of participants | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Tenderness: Any (n=104,110) | 59.6 | 52.7 |
| Tenderness: Significant (n=96,103) | 5.2 | 7.8 |
| Swelling: Any (n=104,110) | 53.8 | 54.5 |
| Swelling: Mild (n=104,109) | 50.0 | 52.3 |
| Swelling: Moderate (n=100,105) | 24.0 | 29.5 |
| Swelling: Severe (n=95,101) | 0.0 | 0.0 |
| Redness: Any (n=104,113) | 62.5 | 59.3 |
| Redness: Mild (n=103,113) | 52.4 | 51.3 |
| Redness: Moderate (n=98,106) | 20.4 | 26.4 |
| Redness: Severe (n=95,101) | 0.0 | 0.0 |
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
| Percentage of participants | 13vPnC/13vPnC |
|---|---|
| Fever ≥38 degrees C but ≤39 degrees C (n=103) | 26.2 |
| Fever >39 degrees C but ≤40 degrees C (n=99) | 2.0 |
| Fever >40 degrees C (n=99) | 0.0 |
| Decreased appetite (n=107) | 36.4 |
| Irritability (n=114) | 80.7 |
| Increased sleep (n=106) | 50.9 |
| Decreased sleep (n=112) | 39.3 |
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
| Percentage of participants | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Fever ≥38 degrees C but ≤39 degrees C (n=99,105) | 31.3 | 32.4 |
| Fever >39 degrees C but ≤40 degrees C (n=96,102) | 5.2 | 3.9 |
| Fever >40 degrees C (n=95,101) | 0.0 | 0.0 |
| Decreased appetite (n=103,109) | 46.6 | 44.0 |
| Irritability (n=111,113) | 82.0 | 76.1 |
| Increased sleep (n=101,108) | 49.5 | 38.9 |
| Decreased sleep (n=105,106) | 36.2 | 33.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13vPnC/13vPnC at 5 Months | — | 1/118 (0.8%) | 92/118 (78%) |
| 13vPnC/13vPnC at 6 Months of Age | — | 4/118 (3.4%) | 4/118 (3.4%) |
| 13vPnC/13vPnC at 12 Months | — | 1/116 (0.9%) | 91/116 (78.4%) |
| 13vPnC at 12 Months | — | 0/116 (0%) | 86/116 (74.1%) |
| Event | 13vPnC/13vPnC at 5 Months | 13vPnC/13vPnC at 6 Months of Age | 13vPnC/13vPnC at 12 Months | 13vPnC at 12 Months |
|---|---|---|---|---|
| GastroenteritisInfections and infestations | 0/118 | 4/118 | 0/116 | 0/116 |
| DiarrhoeaGastrointestinal disorders | 1/118 | 0/118 | 1/116 | 0/116 |
| VomitingGastrointestinal disorders | 0/118 | 0/118 | 1/116 | 0/116 |
| BronchitisInfections and infestations | 0/118 | 0/118 | 1/116 | 0/116 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/118 | 0/118 | 1/116 | 0/116 |
| IntussusceptionGastrointestinal disorders | 0/118 | 1/118 | 0/116 | 0/116 |
| Foreign bodyInjury, poisoning and procedural complications | 0/118 | 1/118 | 0/116 | 0/116 |
| Event | 13vPnC/13vPnC at 5 Months | 13vPnC/13vPnC at 6 Months of Age | 13vPnC/13vPnC at 12 Months | 13vPnC at 12 Months |
|---|---|---|---|---|
| IrritabilityGeneral disorders | 92/114 | — | 91/111 | 86/113 |
| Redness (Any)Skin and subcutaneous tissue disorders | 43/107 | — | 65/104 | 67/113 |
| Tenderness (Any)Skin and subcutaneous tissue disorders | 39/108 | — | 62/104 | 58/110 |
| Swelling (Any)Skin and subcutaneous tissue disorders | 35/104 | — | 56/104 | 60/110 |
| Redness (Mild)Skin and subcutaneous tissue disorders | 39/107 | — | 54/103 | 58/113 |
| Swelling (Mild)Skin and subcutaneous tissue disorders | 33/104 | — | 52/104 | 57/109 |
| Increased sleepGeneral disorders | 54/106 | — | 50/101 | 42/108 |
| Decreased appetiteGeneral disorders | 39/107 | — | 48/103 | 48/109 |
| Decreased sleepGeneral disorders | 44/112 | — | 38/105 | 35/106 |
| Fever ≥38°C but ≤39°CGeneral disorders | 27/103 | — | 31/99 | 34/105 |
| Age Continuous(months) | 13vPnC/13vPnC | 13vPnC | Total |
|---|---|---|---|
| Mean | 5.1 ± 0.37 | 11.9 ± 0.52 | 8.5 ± 3.42 |
| Sex/Gender, Customized(participants) | 13vPnC/13vPnC | 13vPnC | Total |
|---|---|---|---|
| Female | 50 | 60 | 110 |
| Male | 68 | 56 | 124 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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