REPLAY: Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00853749
Collaborator
Pfizer (Industry)
89
2
1
7.4
44.5
6
Study Details
Study Description
Brief Summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Study Design
Study Type:
Interventional
Actual Enrollment
:
89 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
Actual Study Start Date
:
May 5, 2009
Actual Primary Completion Date
:
Dec 16, 2009
Actual Study Completion Date
:
Dec 16, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single All subjects will receive a single dose of 13vPnC |
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL intramuscular injection
Procedure: Blood draw
Collection of 10 mL of blood
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving a 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 [Day 28]
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
- Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination [Day 28]
Percentage of participants achieving OPA 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.
Secondary Outcome Measures
- Antibody Response Measured 1 Month After Vaccination (Avidity Assay) [Day 28]
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
- Antibody Response Measured 1 Month After Vaccination (OPA) [Day 28]
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Other Outcome Measures
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination [Day 28]
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.
- Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination [Day 1 through Day 4]
Local reactions were reported by the parent/legal guardian using a diary card. 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). Participants may have been represented in more than 1 category.
- Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination [Day 1 through Day 4]
Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
-
Subjects must be in good health as determined by medical history, physical examination and clinical judgment.
Exclusion Criteria:
-
Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
-
History of documented invasive pneumococcal disease (defined as a positive culture of
- pneumoniae from a normally sterile body site).
-
Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
-
Receipt of immune-globulin within the past 3 months.
-
Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Landspitali University Hospital | Hringbraut | Reykjavik | Iceland | 101 |
| 2 | Midstod Heilsuverndar barna | Reykjavik | Iceland | 109 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00853749
Other Study ID Numbers:
- 6096A1-3013
- B1851012
- 2008-006194-33
First Posted:
Mar 2, 2009
Last Update Posted:
Nov 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Period Title: Overall Study | ||
| STARTED | 50 | 39 |
| Vaccinated | 50 | 39 |
| COMPLETED | 50 | 38 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC | Total |
|---|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). | Total of all reporting groups |
| Overall Participants | 50 | 39 | 89 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
7.6
(0.2)
|
7.6
(0.2)
|
7.6
(0.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
50%
|
20
51.3%
|
45
50.6%
|
| Male |
25
50%
|
19
48.7%
|
44
49.4%
|
Outcome Measures
| Title | Percentage of Participants Achieving a 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 |
|---|---|
| Description | Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 37 |
| Common Serotype 4 |
100.0
200%
|
97.3
249.5%
|
| Common Serotype 6B |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 9V |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 14 |
100.0
200%
|
100.0
256.4%
|
| Common Serotype18C |
100.0
200%
|
97.3
249.5%
|
| Common Serotype 19F |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 23F |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 1 |
100.0
200%
|
97.3
249.5%
|
| Additional Serotype 3 |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 5 |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 6A |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 7F |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 19A |
100.0
200%
|
100.0
256.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 2.7 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to 14.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 6B | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 9V | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.8 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 18C | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 2.7 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to 14.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 19F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 23F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 1 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 2.7 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to 14.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 5 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 6A | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 7F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 19A | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination |
|---|---|
| Description | Percentage of participants achieving OPA 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 | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 37 |
| Common Serotype 4 |
98.0
196%
|
97.2
249.2%
|
| Common Serotype 6B |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 9V |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 14 |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 18C |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 19F |
100.0
200%
|
100.0
256.4%
|
| Common Serotype 23F |
98.0
196%
|
100.0
256.4%
|
| Additional Serotype 1 |
100.0
200%
|
97.3
249.5%
|
| Additional Serotype 3 |
98.0
196%
|
100.0
256.4%
|
| Additional Serotype 5 |
98.0
196%
|
97.3
249.5%
|
| Additional Serotype 6A |
100.0
200%
|
100.0
256.4%
|
| Additional Serotype 7F |
98.0
196%
|
100.0
256.4%
|
| Additional Serotype 19A |
100.0
200%
|
100.0
256.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% -8.6 to 12.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 6B | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.5 to 9.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 9V | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.5 to 9.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.5 to 9.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 18C | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.4 to 10.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 19F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.5 to 10.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for common serotype 23F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -10.8 to 8.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 1 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 2.7 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to 14.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -11.1 to 7.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 5 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% -8.5 to 12.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 6A | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 7F | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -11.3 to 7.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for additional serotype 19A | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in proportions (percentage) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 9.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) |
|---|---|
| Description | Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5). |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 36 |
| Additional serotype 1 |
1.42
|
4.68
|
| Additional serotype 5 |
1.85
|
5.85
|
| Common serotype 6B |
2.43
|
5.48
|
| Common serotype 19F |
2.17
|
2.46
|
| Common serotype 23F |
3.02
|
6.43
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric means |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% 0.22 to 0.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric means |
| Estimated Value | 0.32 | |
| Confidence Interval |
(2-Sided) 95% 0.23 to 0.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric means |
| Estimated Value | 0.44 | |
| Confidence Interval |
(2-Sided) 95% 0.29 to 0.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric means |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric means |
| Estimated Value | 0.47 | |
| Confidence Interval |
(2-Sided) 95% 0.34 to 0.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Title | Antibody Response Measured 1 Month After Vaccination (OPA) |
|---|---|
| Description | Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 37 |
| Common Serotype 4 |
2374
|
3765
|
| Common Serotype 6B |
11156
|
11477
|
| Common Serotype 9V |
1651
|
1713
|
| Common Serotype 14 |
3041
|
3048
|
| Common Serotype 18C |
3230
|
5684
|
| Common Serotype 19F |
1266
|
1198
|
| Common Serotype 23F |
1678
|
2714
|
| Additional Serotype 1 |
217
|
1087
|
| Additional Serotype 3 |
153
|
188
|
| Additional Serotype 5 |
264
|
719
|
| Additional Serotype 6A |
7060
|
5034
|
| Additional Serotype 7F |
5835
|
7887
|
| Additional Serotype 19A |
1256
|
1556
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.35 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.51 to 1.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 1.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.72 to 1.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% 0.12 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.56 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% 0.21 to 0.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% 0.88 to 2.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.54 to 1.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Title | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination |
|---|---|
| Description | Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw. |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 37 |
| Common serotype 4 |
4.18
|
11.34
|
| Common serotype 6B |
29.51
|
41.70
|
| Common serotype 9V |
4.31
|
7.39
|
| Common serotype 14 |
17.47
|
22.78
|
| Common serotype 18C |
2.76
|
4.83
|
| Common serotype 19F |
9.78
|
11.60
|
| Common serotype 23F |
7.89
|
12.25
|
| Additional serotype 1 |
5.28
|
19.43
|
| Additional serotype 3 |
3.28
|
2.87
|
| Additional serotype 5 |
5.75
|
15.98
|
| Additional serotype 6A |
11.16
|
14.07
|
| Additional serotype 7F |
7.13
|
8.05
|
| Additional serotype 19A |
14.62
|
17.07
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) 95% 0.25 to 0.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.44 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.58 | |
| Confidence Interval |
(2-Sided) 95% 0.45 to 0.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.57 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 0.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 95% 0.56 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.64 | |
| Confidence Interval |
(2-Sided) 95% 0.44 to 0.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.27 | |
| Confidence Interval |
(2-Sided) 95% 0.18 to 0.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 1.14 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.36 | |
| Confidence Interval |
(2-Sided) 95% 0.25 to 0.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.79 | |
| Confidence Interval |
(2-Sided) 95% 0.55 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMCs |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | |
| Title | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination |
|---|---|
| Description | Local reactions were reported by the parent/legal guardian using a diary card. 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). Participants may have been represented in more than 1 category. |
| Time Frame | Day 1 through Day 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days and "number analyzed" signifies participants reporting the specific characteristic. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 39 |
| Tenderness: Any |
88.0
176%
|
76.9
197.2%
|
| Tenderness: Significant |
12.0
24%
|
20.5
52.6%
|
| Redness: Any |
50.0
100%
|
66.7
171%
|
| Redness: Mild |
10.0
20%
|
15.8
40.5%
|
| Redness: Moderate |
40.0
80%
|
52.6
134.9%
|
| Redness: Severe |
10.0
20%
|
21.1
54.1%
|
| Swelling: Any |
44.0
88%
|
59.0
151.3%
|
| Swelling: Mild |
16.3
32.6%
|
26.3
67.4%
|
| Swelling: Moderate |
28.6
57.2%
|
44.7
114.6%
|
| Swelling: Severe |
2.0
4%
|
7.9
20.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for any tenderness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.253 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for significant tenderness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.380 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for any redness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.135 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for mild redness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.520 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for moderate redness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.283 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for severe redness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.225 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for any swelling | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.202 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for mild swelling | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.294 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for moderate swelling | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.175 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for severe swelling | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.314 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination |
|---|---|
| Description | Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category. |
| Time Frame | Day 1 through Day 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety; N=number of participants reporting yes for at least 1 day or no for all days and number analyzed signifies participants reporting the specific characteristic. |
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC |
|---|---|---|
| Arm/Group Description | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Measure Participants | 50 | 39 |
| Fever ≥ 38 degrees C but ≤ 39 degrees C |
2.0
4%
|
2.8
7.2%
|
| Decreased appetite |
12.2
24.4%
|
10.3
26.4%
|
| Irritability |
18.4
36.8%
|
11.4
29.2%
|
| Increased sleep |
4.0
8%
|
12.8
32.8%
|
| Decreased sleep |
5.1
10.2%
|
|
| Rash |
6.0
12%
|
2.6
6.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | > .99 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for decreased appetite | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | > .99 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for irritability | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.543 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for increased sleep | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.233 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for decreased sleep | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.198 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PCV/23vPS/13vPnC, PCV/PCV/13vPnC |
|---|---|---|
| Comments | Comparison between treatments for rash | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.628 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||
| Arm/Group Title | PCV/23vPS/13vPnC | PCV/PCV/13vPnC | ||
| Arm/Group Description | For this study, participants received a single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9. | For this study, participants received a single 0.5 mL dose of 13vPnC, administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5. | ||
All Cause Mortality |
||||
| PCV/23vPS/13vPnC | PCV/PCV/13vPnC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PCV/23vPS/13vPnC | PCV/PCV/13vPnC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/39 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PCV/23vPS/13vPnC | PCV/PCV/13vPnC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 44/50 (88%) | 30/39 (76.9%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 1/50 (2%) | 0/39 (0%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 2/50 (4%) | 1/39 (2.6%) | ||
| Diarrhoea | 2/50 (4%) | 0/39 (0%) | ||
| Abdominal pain | 1/50 (2%) | 0/39 (0%) | ||
| Abdominal pain upper | 0/50 (0%) | 1/39 (2.6%) | ||
| General disorders | ||||
| Pyrexia | 1/50 (2%) | 0/39 (0%) | ||
| Fever ≥ 38°C but ≤ 39°C | 1/49 (2%) | 1/36 (2.8%) | ||
| Fever > 39°C but ≤ 40°C | 0/49 (0%) | 0/36 (0%) | ||
| Fever > 40°C | 0/49 (0%) | 0/36 (0%) | ||
| Decreased appetite | 6/49 (12.2%) | 4/39 (10.3%) | ||
| Irritability | 9/49 (18.4%) | 4/35 (11.4%) | ||
| Increased sleep | 2/50 (4%) | 5/39 (12.8%) | ||
| Decreased sleep | 0/48 (0%) | 2/39 (5.1%) | ||
| Rash | 3/50 (6%) | 1/39 (2.6%) | ||
| Infections and infestations | ||||
| Viral infection | 0/50 (0%) | 3/39 (7.7%) | ||
| Influenza | 1/50 (2%) | 1/39 (2.6%) | ||
| Gastroenteritis | 0/50 (0%) | 1/39 (2.6%) | ||
| Pharyngitis | 1/50 (2%) | 0/39 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 0/50 (0%) | 1/39 (2.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 1/50 (2%) | 0/39 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Urticaria | 1/50 (2%) | 0/39 (0%) | ||
| Tenderness (Any) | 44/50 (88%) | 30/39 (76.9%) | ||
| Tenderness (Significant) | 6/50 (12%) | 8/39 (20.5%) | ||
| Redness (Any) | 25/50 (50%) | 26/39 (66.7%) | ||
| Redness (Mild) | 5/50 (10%) | 6/38 (15.8%) | ||
| Redness (Moderate) | 20/50 (40%) | 20/38 (52.6%) | ||
| Redness (Severe) | 5/50 (10%) | 8/38 (21.1%) | ||
| Swelling (Any) | 22/50 (44%) | 23/39 (59%) | ||
| Swelling (Mild) | 8/49 (16.3%) | 10/38 (26.3%) | ||
| Swelling (Moderate) | 14/49 (28.6%) | 17/38 (44.7%) | ||
| Swelling (Severe) | 1/49 (2%) | 3/38 (7.9%) | ||
Limitations/Caveats
Primary analysis based on evaluable immunogenicity population as per analysis plan change.Data for a participant reported in PCV/23vPS/13vPnC instead of PCV/PCV/13vPnC due to data entry error on case report form;this did not affect result conclusion.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00853749
Other Study ID Numbers:
- 6096A1-3013
- B1851012
- 2008-006194-33
First Posted:
Mar 2, 2009
Last Update Posted:
Nov 11, 2021
Last Verified:
Oct 1, 2021