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Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00963235
Collaborator
(none)
331
Enrollment
15
Locations
1
Arm
30
Duration (Months)
22.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.

Condition or Disease Intervention/Treatment Phase
  • Biological: 13-valent pneumococcal conjugate vaccine
  • Procedure: Blood draw
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
331 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Biological: 13-valent pneumococcal conjugate vaccine
Three doses of 13vPnC given 6 months apart.
Other Names:
  • 13vPnC

    • Procedure: Blood draw
    Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.

    Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC [1 month post-dose 2, 1 month post-dose 3]

      Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

    Secondary Outcome Measures

    1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC [1 month post-dose 2, 1 month post-dose 3]

      Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.

    2. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC [1 month post-dose 1, 1 month post-dose 2]

      Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.

    3. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC [1 month post-dose 2, 1 month post-dose 3]

      Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 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 both post-dose 2 and post-dose 3 blood draws.

    4. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC [1 month post-dose 1, 1 month post-dose 2]

      Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 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 both post-dose 2 and post-dose 3 blood draws.

    5. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC [1 month post-dose 2, 1 month post-dose 3]

      GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

    6. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC [1 month post-dose 1, 1 month post-dose 2]

      GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

    Other Outcome Measures

    1. Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1 [Within 14 days post-dose 1]

      Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

    2. Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2 [Within 14 days post-dose 2]

      Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

    3. Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3 [Within 14 days post-dose 3]

      Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

    4. Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1 [Within 14 days post-dose 1]

      Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.

    5. Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2 [Within 14 days post-dose 2]

      Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).

    6. Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3 [Within 14 days post-dose 3]

      Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female subjects aged 18 years or older at the time of enrollment.

    • All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.

    • Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.

    • CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.

    • HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.

    • Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy.

    • Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone.

    • Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.

    • Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)

    Exclusion Criteria:

    • Subjects with active AIDS related illness, including opportunistic infections or malignancy.

    • Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives..

    • Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment.

    • Contraindication to vaccination with pneumococcal conjugate vaccine.

    • Previous anaphylactic reaction to any vaccine or vaccine-related component.

    • History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year.

    • Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.)

    • Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test.

    • History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months.

    • Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease).

    • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.

    • History of splenectomy.

    • Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination).

    • Evidence of dementia or other severe cognitive impairment.

    • Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass.

    • Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.)

    • Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial.

    • Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel.

    Temporary Delay Criteria:

    • Current febrile illness (oral temperature of =38.0°C [100.4°F]) or other acute illness within 48 hours before study vaccine administration.

    • Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration.

    • Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site San Francisco California United States 94115
    2 Pfizer Investigational Site Aurora Colorado United States 80045
    3 Pfizer Investigational Site Washington District of Columbia United States 20009
    4 Pfizer Investigational Site Lexington Kentucky United States 40536
    5 Pfizer Investigational Site Springfield Massachusetts United States 01199
    6 Pfizer Investigational Site St. Louis Missouri United States 63110
    7 Pfizer Investigational Site New York New York United States 10011
    8 Pfizer Investigational Site New York New York United States 10016
    9 Pfizer Investigational Site New York New York United States 10029
    10 Pfizer Investigational Site New York New York United States 10032
    11 Pfizer Investigational Site New York New York United States 10065
    12 Pfizer Investigational Site Rochester New York United States 14642
    13 Pfizer Investigational Site Johnson City Tennessee United States 37604
    14 Pfizer Investigational Site Austin Texas United States 78705
    15 Pfizer Investigational Site Dallas Texas United States 75246

    Sponsors and Collaborators

    • 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:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00963235
    Other Study ID Numbers:
    • 6115A1-3017
    • B1851028
    First Posted:
    Aug 21, 2009
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Pfizer
    vaccine
    13-valent pneumococcal conjugate vaccine
    human immunodeficiency virus
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Pneumococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Period Title: Overall Study
    STARTED 331
    Vaccinated Dose 1 329
    Vaccinated Dose 2 300
    Vaccinated Dose 3 279
    Completed Dose 3 1-month Blood Draw 277
    COMPLETED 271
    NOT COMPLETED 60

    Baseline Characteristics

    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Overall Participants 329
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47.3
    (9.10)
    Sex: Female, Male (Count of Participants)
    Female
    66
    20.1%
    Male
    263
    79.9%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
    Description Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
    Time Frame 1 month post-dose 2, 1 month post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 223
    Serotype 1
    0.94
    Serotype 3
    1.01
    Serotype 4
    1.01
    Serotype 5
    0.99
    Serotype 6A
    1.19
    Serotype 6B
    1.21
    Serotype 7F
    1.07
    Serotype 9V
    1.08
    Serotype 14
    1.08
    Serotype 18C
    1.09
    Serotype 19A
    1.03
    Serotype 19F
    1.17
    Serotype 23F
    1.25
    2. Secondary Outcome
    Title Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
    Description Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
    Time Frame 1 month post-dose 2, 1 month post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 223
    Serotype 1: Dose 2
    2.31
    Serotype 1: Dose 3
    2.18
    Serotype 3: Dose 2
    0.54
    Serotype 3: Dose 3
    0.55
    Serotype 4: Dose 2
    1.62
    Serotype 4: Dose 3
    1.63
    Serotype 5: Dose 2
    3.26
    Serotype 5: Dose 3
    3.23
    Serotype 6A: Dose 2
    3.86
    Serotype 6A: Dose 3
    4.60
    Serotype 6B: Dose 2
    4.49
    Serotype 6B: Dose 3
    5.45
    Serotype 7F: Dose 2
    3.40
    Serotype 7F: Dose 3
    3.62
    Serotype 9V: Dose 2
    2.95
    Serotype 9V: Dose 3
    3.20
    Serotype 14: Dose 2
    7.57
    Serotype 14: Dose 3
    8.16
    Serotype 18C: Dose 2
    2.75
    Serotype 18C: Dose 3
    2.99
    Serotype 19A: Dose 2
    7.57
    Serotype 19A: Dose 3
    7.80
    Serotype 19F: Dose 2
    5.73
    Serotype 19F: Dose 3
    6.70
    Serotype 23F: Dose 2
    3.80
    Serotype 23F: Dose 3
    4.77
    3. Secondary Outcome
    Title Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
    Description Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.
    Time Frame 1 month post-dose 1, 1 month post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 242
    Serotype 1: Dose 1
    2.15
    Serotype 1: Dose 2
    2.36
    Serotype 3: Dose 1
    0.48
    Serotype 3: Dose 2
    0.57
    Serotype 4: Dose 1
    1.37
    Serotype 4: Dose 2
    1.64
    Serotype 5: Dose 1
    2.90
    Serotype 5: Dose 2
    3.29
    Serotype 6A: Dose 1
    2.80
    Serotype 6A: Dose 2
    3.86
    Serotype 6B: Dose 1
    2.90
    Serotype 6B: Dose 2
    4.47
    Serotype 7F: Dose 1
    3.45
    Serotype 7F: Dose 2
    3.41
    Serotype 9V: Dose 1
    2.63
    Serotype 9V: Dose 2
    2.99
    Serotype 14: Dose 1
    6.18
    Serotype 14: Dose 2
    7.60
    Serotype 18C: Dose 1
    2.87
    Serotype 18C: Dose 2
    2.68
    Serotype 19A: Dose 1
    6.53
    Serotype 19A: Dose 2
    7.63
    Serotype 19F: Dose 1
    2.75
    Serotype 19F: Dose 2
    5.70
    Serotype 23F: Dose 1
    2.62
    Serotype 23F: Dose 2
    3.82
    4. Secondary Outcome
    Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
    Description Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 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 both post-dose 2 and post-dose 3 blood draws.
    Time Frame 1 month post-dose 2, 1 month post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 219
    Serotype 1: Dose 2
    41
    Serotype 1: Dose 3
    49
    Serotype 3: Dose 2
    44
    Serotype 3: Dose 3
    56
    Serotype 4: Dose 2
    703
    Serotype 4: Dose 3
    724
    Serotype 5: Dose 2
    67
    Serotype 5: Dose 3
    74
    Serotype 6A: Dose 2
    1780
    Serotype 6A: Dose 3
    2139
    Serotype 6B: Dose 2
    1857
    Serotype 6B: Dose 3
    2447
    Serotype 7F: Dose 2
    942
    Serotype 7F: Dose 3
    1041
    Serotype 9V: Dose 2
    657
    Serotype 9V: Dose 3
    922
    Serotype 14: Dose 2
    746
    Serotype 14: Dose 3
    819
    Serotype 18C: Dose 2
    521
    Serotype 18C: Dose 3
    692
    Serotype 19A: Dose 2
    401
    Serotype 19A: Dose 3
    419
    Serotype 19F: Dose 2
    269
    Serotype 19F: Dose 3
    245
    Serotype 23F: Dose 2
    293
    Serotype 23F: Dose 3
    393
    5. Secondary Outcome
    Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
    Description Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 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 both post-dose 2 and post-dose 3 blood draws.
    Time Frame 1 month post-dose 1, 1 month post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 241
    Serotype 1: Dose 1
    40
    Serotype 1: Dose 2
    40
    Serotype 3: Dose 1
    29
    Serotype 3: Dose 2
    43
    Serotype 4: Dose 1
    622
    Serotype 4: Dose 2
    695
    Serotype 5: Dose 1
    66
    Serotype 5: Dose 2
    65
    Serotype 6A: Dose 1
    976
    Serotype 6A: Dose 2
    1687
    Serotype 6B: Dose 1
    1088
    Serotype 6B: Dose 2
    1789
    Serotype 7F: Dose 1
    786
    Serotype 7F: Dose 2
    927
    Serotype 9V: Dose 1
    423
    Serotype 9V: Dose 2
    695
    Serotype 14: Dose 1
    640
    Serotype 14: Dose 2
    723
    Serotype 18C: Dose 1
    475
    Serotype 18C: Dose 2
    562
    Serotype 19A: Dose 1
    299
    Serotype 19A: Dose 2
    391
    Serotype 19F: Dose 1
    132
    Serotype 19F: Dose 2
    247
    Serotype 23F: Dose 1
    92
    Serotype 23F: Dose 2
    269
    6. Secondary Outcome
    Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
    Description GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
    Time Frame 1 month post-dose 2, 1 month post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 219
    Serotype 1
    1.2
    Serotype 3
    1.3
    Serotype 4
    1.0
    Serotype 5
    1.1
    Serotype 6A
    1.2
    Serotype 6B
    1.3
    Serotype 7F
    1.1
    Serotype 9V
    1.4
    Serotype 14
    1.1
    Serotype 18C
    1.3
    Serotype 19A
    1.0
    Serotype 19F
    0.9
    Serotype 23F
    1.3
    7. Secondary Outcome
    Title Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
    Description GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
    Time Frame 1 month post-dose 1, 1 month post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 241
    Serotype 1
    1.0
    Serotype 3
    1.5
    Serotype 4
    1.1
    Serotype 5
    1.0
    Serotype 6A
    1.7
    Serotype 6B
    1.6
    Serotype 7F
    1.2
    Serotype 9V
    1.6
    Serotype 14
    1.1
    Serotype 18C
    1.2
    Serotype 19A
    1.3
    Serotype 19F
    1.9
    Serotype 23F
    2.9
    8. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
    Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
    Time Frame Within 14 days post-dose 1

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 261
    Redness: any (n = 162)
    5.6
    1.7%
    Redness: mild (n = 161)
    4.3
    1.3%
    Redness: moderate (n = 158)
    1.3
    0.4%
    Redness: severe (n = 157)
    0.0
    0%
    Swelling: any (n = 162)
    6.8
    2.1%
    Swelling: mild (n = 161)
    6.2
    1.9%
    Swelling: moderate (n = 158)
    0.6
    0.2%
    Swelling: severe (n = 158)
    0.6
    0.2%
    Pain: any (n = 260)
    78.8
    24%
    Pain: mild (n = 258)
    76.4
    23.2%
    Pain: moderate (n = 173)
    18.5
    5.6%
    Pain: severe (n = 158)
    1.3
    0.4%
    9. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
    Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
    Time Frame Within 14 days post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 238
    Redness: any (n = 122)
    8.2
    2.5%
    Redness: mild (n = 120)
    6.7
    2%
    Redness: moderate (n = 117)
    1.7
    0.5%
    Redness: severe (n = 117)
    1.7
    0.5%
    Swelling: any (n = 126)
    12.7
    3.9%
    Swelling: mild (n = 125)
    12.0
    3.6%
    Swelling: moderate (n = 116)
    0.9
    0.3%
    Swelling: severe (n = 117)
    1.7
    0.5%
    Pain: any (n = 237)
    81.4
    24.7%
    Pain: mild (n = 230)
    78.7
    23.9%
    Pain: moderate (n = 150)
    33.3
    10.1%
    Pain: severe (n = 123)
    8.1
    2.5%
    10. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
    Description Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
    Time Frame Within 14 days post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 205
    Redness: any (n = 105)
    9.5
    2.9%
    Redness: mild (n = 104)
    8.7
    2.6%
    Redness: moderate (n = 102)
    3.9
    1.2%
    Redness: severe (n = 101)
    1.0
    0.3%
    Swelling: any (n = 107)
    11.2
    3.4%
    Swelling: mild (n = 106)
    8.5
    2.6%
    Swelling: moderate (n = 102)
    3.9
    1.2%
    Swelling: severe (n = 101)
    1.0
    0.3%
    Pain: any (n = 204)
    81.9
    24.9%
    Pain: mild (n = 197)
    80.2
    24.4%
    Pain: moderate (n = 129)
    30.2
    9.2%
    Pain: severe (n = 105)
    5.7
    1.7%
    11. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
    Description Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.
    Time Frame Within 14 days post-dose 1

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 276
    Fever >=38 degrees C (n = 162)
    6.2
    1.9%
    Fever >=38, <38.5 degrees C (n = 160)
    3.8
    1.2%
    Fever >=38.5, <39 degrees C (n = 157)
    1.3
    0.4%
    Fever >=39, =<40 degrees C (n = 159)
    1.3
    0.4%
    Fever >40 degrees C (n = 158)
    0.6
    0.2%
    Fatigue: any (n = 235)
    60.0
    18.2%
    Fatigue: mild (n = 223)
    54.3
    16.5%
    Fatigue: moderate (n = 200)
    37.5
    11.4%
    Fatigue: severe (n = 163)
    6.1
    1.9%
    Headache: any (n = 224)
    61.6
    18.7%
    Headache: mild (n = 216)
    57.4
    17.4%
    Headache: moderate (n = 183)
    31.1
    9.5%
    Headache: severe (n = 160)
    3.1
    0.9%
    Vomiting: any (n = 164)
    11.6
    3.5%
    Vomiting: mild (n = 164)
    11.6
    3.5%
    Vomiting: moderate (n = 157)
    0.0
    0%
    Vomiting: severe (n = 157)
    0.0
    0%
    Diarrhea: any (n = 193)
    44.0
    13.4%
    Diarrhea: mild (n = 191)
    40.3
    12.2%
    Diarrhea: moderate (n = 166)
    12.7
    3.9%
    Diarrhea: severe (n = 160)
    1.9
    0.6%
    New generalized muscle pain: any (n = 234)
    65.0
    19.8%
    New generalized muscle pain: mild (n = 230)
    60.4
    18.4%
    New generalized muscle pain: moderate (n = 183)
    29.5
    9%
    New generalized muscle pain: severe (n = 161)
    3.7
    1.1%
    New generalized joint pain: any (n = 193)
    35.8
    10.9%
    New generalized joint pain: mild (n = 185)
    29.7
    9%
    New generalized joint pain: moderate (n = 172)
    19.2
    5.8%
    New generalized joint pain: severe (n = 159)
    1.3
    0.4%
    Use of medication to treat pain (n = 185)
    29.7
    9%
    Use of medication to treat fever (n = 173)
    17.3
    5.3%
    12. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
    Description Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).
    Time Frame Within 14 days post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 229
    Fever >=38 degrees C (n = 117)
    5.1
    1.6%
    Fever >=38, <38.5 degrees C (n = 116)
    4.3
    1.3%
    Fever >=38.5, <39 degrees C (n = 116)
    0.9
    0.3%
    Fever >=39, =<40 degrees C (n = 115)
    0.0
    0%
    Fever >40 degrees C (n = 115)
    0.0
    0%
    Fatigue: any (n = 188)
    63.3
    19.2%
    Fatigue: mild (n = 176)
    57.4
    17.4%
    Fatigue: moderate (n = 154)
    38.3
    11.6%
    Fatigue: severe (n = 121)
    7.4
    2.2%
    Headache: any (n = 173)
    56.1
    17.1%
    Headache: mild (n = 165)
    48.5
    14.7%
    Headache: moderate (n = 142)
    31.0
    9.4%
    Headache: severe (n = 117)
    3.4
    1%
    Vomiting: any (n = 120)
    7.5
    2.3%
    Vomiting: mild (n = 119)
    6.7
    2%
    Vomiting: moderate (n = 116)
    0.9
    0.3%
    Vomiting: severe (n = 115)
    0.0
    0%
    Diarrhea: any (n = 155)
    44.5
    13.5%
    Diarrhea: mild (n = 147)
    39.5
    12%
    Diarrhea: moderate (n = 130)
    15.4
    4.7%
    Diarrhea: severe (n = 119)
    5.0
    1.5%
    New generalized muscle pain: any (n = 199)
    71.9
    21.9%
    New generalized muscle pain: mild (n = 188)
    66.0
    20.1%
    New generalized muscle pain: moderate (n = 153)
    38.6
    11.7%
    New generalized muscle pain: severe (n = 125)
    10.4
    3.2%
    New generalized joint pain: any (n = 150)
    40.0
    12.2%
    New generalized joint pain: mild (n = 144)
    34.7
    10.5%
    New generalized joint pain: moderate (n = 135)
    21.5
    6.5%
    New generalized joint pain: severe (n = 119)
    3.4
    1%
    Use of medication to treat pain (n = 141)
    35.5
    10.8%
    Use of medication to treat fever (n = 127)
    18.9
    5.7%
    13. Other Pre-specified Outcome
    Title Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
    Description Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).
    Time Frame Within 14 days post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
    Arm/Group Title 13vPnC
    Arm/Group Description Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
    Measure Participants 203
    Fever >=38 degrees C (n = 104)
    7.7
    2.3%
    Fever >=38, <38.5 degrees C (n = 104)
    4.8
    1.5%
    Fever >=38.5, <39 degrees C (n = 101)
    1.0
    0.3%
    Fever >=39, =<40 degrees C (n = 101)
    2.0
    0.6%
    Fever >40 degrees C (n = 101)
    0.0
    0%
    Fatigue: any (n = 160)
    56.3
    17.1%
    Fatigue: mild (n = 149)
    48.3
    14.7%
    Fatigue: moderate (n = 132)
    36.4
    11.1%
    Fatigue: severe (n = 105)
    5.7
    1.7%
    Headache: any (n = 137)
    46.7
    14.2%
    Headache: mild (n = 130)
    40.8
    12.4%
    Headache: moderate (n = 118)
    24.6
    7.5%
    Headache: severe (n = 103)
    4.9
    1.5%
    Vomiting: any (n = 109)
    11.0
    3.3%
    Vomiting: mild (n = 107)
    8.4
    2.6%
    Vomiting: moderate (n = 104)
    4.8
    1.5%
    Vomiting: severe (n = 101)
    0.0
    0%
    Diarrhea: any (n = 134)
    38.8
    11.8%
    Diarrhea: mild (n = 131)
    35.9
    10.9%
    Diarrhea: moderate (n = 109)
    11.9
    3.6%
    Diarrhea: severe (n = 103)
    1.9
    0.6%
    New generalized muscle pain: any (n = 170)
    65.9
    20%
    New generalized muscle pain: mild (n = 155)
    61.3
    18.6%
    New generalized muscle pain: moderate (n = 132)
    31.1
    9.5%
    New generalized muscle pain: severe (n = 110)
    10.0
    3%
    New generalized joint pain: any (n = 129)
    31.8
    9.7%
    New generalized joint pain: mild (n = 119)
    26.1
    7.9%
    New generalized joint pain: moderate (n = 120)
    20.0
    6.1%
    New generalized joint pain: severe (n = 106)
    5.7
    1.7%
    Use of medication to treat pain (n = 122)
    32.0
    9.7%
    Use of medication to treat fever (n = 118)
    25.4
    7.7%

    Adverse Events

    Time Frame Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
    Adverse Event Reporting Description SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
    Arm/Group Title 13vPnC (After Dose 1 and Before Dose 2) 13vPnC (After Dose 2 and Before Dose 3) 13vPnC (After Dose 3 and Before Dose 3 Blood Draw) 13vPnC (After Dose 3 Blood Draw)
    Arm/Group Description Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2. Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3. Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3. Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
    All Cause Mortality
    13vPnC (After Dose 1 and Before Dose 2) 13vPnC (After Dose 2 and Before Dose 3) 13vPnC (After Dose 3 and Before Dose 3 Blood Draw) 13vPnC (After Dose 3 Blood Draw)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    13vPnC (After Dose 1 and Before Dose 2) 13vPnC (After Dose 2 and Before Dose 3) 13vPnC (After Dose 3 and Before Dose 3 Blood Draw) 13vPnC (After Dose 3 Blood Draw)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/329 (7.3%) 14/300 (4.7%) 4/278 (1.4%) 10/329 (3%)
    Blood and lymphatic system disorders
    Anaemia 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Cardiac disorders
    Coronary artery disease 3/329 (0.9%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Myocardial infarction 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Angina pectoris 0/329 (0%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Prinzmetal angina 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Angina unstable 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Gastrointestinal disorders
    Diarrhoea 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Erosive oesophagitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Pancreatitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Small intestinal obstruction 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    General disorders
    Non-cardiac chest pain 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Oedema peripheral 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Chest discomfort 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Hepatobiliary disorders
    Gallbladder disorder 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Cholelithiasis 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Infections and infestations
    Bronchitis viral 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Mediastinal abscess 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Mycobacterium abscessus infection 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Pneumonia streptococcal 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Staphylococcal skin infection 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Anal abscess 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Cytomegalovirus hepatitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Pneumonia 0/329 (0%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Pneumonia cytomegaloviral 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Bronchitis 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Injury, poisoning and procedural complications
    Upper limb fracture 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Procedural pain 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 2/329 (0.6%)
    Carcinoma in situ of penis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Prostate cancer 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Brain neoplasm 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Neuroendocrine carcinoma of the skin 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Tongue neoplasm malignant stage unspecified 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Nervous system disorders
    Complicated migraine 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Convulsion 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Headache 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Convulsion 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Loss of consciousness 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Psychiatric disorders
    Depression 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Substance abuse 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Alcohol abuse 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 1/329 (0.3%)
    Renal and urinary disorders
    Bladder prolapse 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Menometrorrhagia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Pulmonary embolism 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Respiratory failure 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Vascular disorders
    Deep vein thrombosis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Aortic stenosis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Peripheral arterial occlusive disease 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Aortic aneurysm 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Other (Not Including Serious) Adverse Events
    13vPnC (After Dose 1 and Before Dose 2) 13vPnC (After Dose 2 and Before Dose 3) 13vPnC (After Dose 3 and Before Dose 3 Blood Draw) 13vPnC (After Dose 3 Blood Draw)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 244/329 (74.2%) 196/300 (65.3%) 169/278 (60.8%) 30/329 (9.1%)
    Blood and lymphatic system disorders
    Lymphadenopathy 3/329 (0.9%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Anaemia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Coagulopathy 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Polycythaemia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Microcytic anaemia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Cardiac disorders
    Atrial fibrillation 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Palpitations 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Tachycardia 0/329 (0%) 2/300 (0.7%) 0/278 (0%) 1/329 (0.3%)
    Ear and labyrinth disorders
    Deafness neurosensory 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Ear pain 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 1/329 (0.3%)
    Tinnitus 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Vertigo 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Cerumen impaction 0/329 (0%) 0/300 (0%) 3/278 (1.1%) 0/329 (0%)
    Deafness unilateral 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Eustachian tube disorder 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Eye disorders
    Eye irritation 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Vision blurred 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Episcleritis 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Iritis 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Gastrointestinal disorders
    Diarrhoea 5/329 (1.5%) 4/300 (1.3%) 1/278 (0.4%) 1/329 (0.3%)
    Nausea 3/329 (0.9%) 1/300 (0.3%) 2/278 (0.7%) 1/329 (0.3%)
    Gastrooesophageal reflux disease 2/329 (0.6%) 1/300 (0.3%) 0/278 (0%) 3/329 (0.9%)
    Oral pain 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Abdominal distension 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Abdominal pain 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Abdominal pain upper 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Anal fissure 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Constipation 1/329 (0.3%) 4/300 (1.3%) 0/278 (0%) 0/329 (0%)
    Flatulence 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Haemorrhoids 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Inguinal hernia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Pancreatitis acute 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Tongue haemorrhage 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Toothache 1/329 (0.3%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Umbilical hernia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Vomiting 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 1/329 (0.3%)
    Dyspepsia 0/329 (0%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Anogenital dysplasia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dental caries 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dry mouth 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Gastrooesophageal reflux disease 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 3/329 (0.9%)
    Gingival swelling 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Diverticulum 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Dysphagia 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Retching 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Irritable bowel syndrome 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Irritable bowel syndrome 0/329 (0%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    General disorders
    Pyrexia 6/329 (1.8%) 1/300 (0.3%) 2/278 (0.7%) 0/329 (0%)
    Fatigue 4/329 (1.2%) 8/300 (2.7%) 1/278 (0.4%) 1/329 (0.3%)
    Influenza like illness 2/329 (0.6%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Asthenia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Chest pain 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Injection site pain 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Injection site paraesthesia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Oedema 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Oedema peripheral 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Pain 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Non-cardiac chest pain 0/329 (0%) 2/300 (0.7%) 1/278 (0.4%) 0/329 (0%)
    Malaise 0/329 (0%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Chills 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Fever (>=38 degrees C) 10/162 (6.2%) 6/117 (5.1%) 8/104 (7.7%) 0/0 (NaN)
    Fever (>=38 but <38.5 degrees C) 6/160 (3.8%) 5/116 (4.3%) 5/104 (4.8%) 0/0 (NaN)
    Fever (>=38.5 but <39 degrees C) 2/157 (1.3%) 1/116 (0.9%) 1/101 (1%) 0/0 (NaN)
    Fever (>=39 but =<40 degrees C) 2/159 (1.3%) 0/115 (0%) 2/101 (2%) 0/0 (NaN)
    Fever (>40 degrees C) 1/158 (0.6%) 0/115 (0%) 0/101 (0%) 0/0 (NaN)
    Fatigue (Any) 141/235 (60%) 119/188 (63.3%) 90/160 (56.3%) 0/0 (NaN)
    Fatigue (Mild) 121/223 (54.3%) 101/176 (57.4%) 72/149 (48.3%) 0/0 (NaN)
    Fatigue (Moderate) 75/200 (37.5%) 59/154 (38.3%) 48/132 (36.4%) 0/0 (NaN)
    Fatigue (Severe) 10/163 (6.1%) 9/121 (7.4%) 6/105 (5.7%) 0/0 (NaN)
    Headache (Any) 138/224 (61.6%) 97/173 (56.1%) 64/137 (46.7%) 0/0 (NaN)
    Headache (Mild) 124/216 (57.4%) 80/165 (48.5%) 53/130 (40.8%) 0/0 (NaN)
    Headache (Moderate) 57/183 (31.1%) 44/142 (31%) 29/118 (24.6%) 0/0 (NaN)
    Headache (Severe) 5/160 (3.1%) 4/117 (3.4%) 5/103 (4.9%) 0/0 (NaN)
    Vomiting (Any) 19/164 (11.6%) 9/120 (7.5%) 12/109 (11%) 0/0 (NaN)
    Vomiting (Mild) 19/164 (11.6%) 8/119 (6.7%) 9/107 (8.4%) 0/0 (NaN)
    Vomiting (Moderate) 0/157 (0%) 1/116 (0.9%) 5/104 (4.8%) 0/0 (NaN)
    Vomiting (Severe) 0/157 (0%) 0/115 (0%) 0/101 (0%) 0/0 (NaN)
    Diarrhea (Any) 85/193 (44%) 69/155 (44.5%) 52/134 (38.8%) 0/0 (NaN)
    Diarrhea (Mild) 77/191 (40.3%) 58/147 (39.5%) 47/131 (35.9%) 0/0 (NaN)
    Diarrhea (Moderate) 21/166 (12.7%) 20/130 (15.4%) 13/109 (11.9%) 0/0 (NaN)
    Diarrhea (Severe) 3/160 (1.9%) 6/119 (5%) 2/103 (1.9%) 0/0 (NaN)
    New generalized muscle pain (Any) 152/234 (65%) 143/199 (71.9%) 112/170 (65.9%) 0/0 (NaN)
    New generalized muscle pain (Mild) 139/230 (60.4%) 124/188 (66%) 95/155 (61.3%) 0/0 (NaN)
    New generalized muscle pain (Moderate) 54/183 (29.5%) 59/153 (38.6%) 41/132 (31.1%) 0/0 (NaN)
    New generalized muscle pain (Severe) 6/161 (3.7%) 13/125 (10.4%) 11/110 (10%) 0/0 (NaN)
    New generalized joint pain (Any) 69/193 (35.8%) 60/150 (40%) 41/129 (31.8%) 0/0 (NaN)
    New generalized joint pain (Mild) 55/185 (29.7%) 50/144 (34.7%) 31/119 (26.1%) 0/0 (NaN)
    New generalized joint pain (Moderate) 33/172 (19.2%) 29/135 (21.5%) 24/120 (20%) 0/0 (NaN)
    New generalized joint pain (Severe) 2/159 (1.3%) 4/119 (3.4%) 6/106 (5.7%) 0/0 (NaN)
    Hepatobiliary disorders
    Cholelithiasis 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hepatic cirrhosis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hyperbilirubinaemia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hepatic steatosis 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Immune system disorders
    Seasonal allergy 2/329 (0.6%) 2/300 (0.7%) 2/278 (0.7%) 0/329 (0%)
    Food allergy 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Drug hypersensitivity 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Hypersensitivity 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Infections and infestations
    Upper respiratory tract infection 17/329 (5.2%) 8/300 (2.7%) 1/278 (0.4%) 0/329 (0%)
    Folliculitis 5/329 (1.5%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Bronchitis 4/329 (1.2%) 2/300 (0.7%) 4/278 (1.4%) 0/329 (0%)
    Laryngitis 3/329 (0.9%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Sinusitis 3/329 (0.9%) 1/300 (0.3%) 3/278 (1.1%) 0/329 (0%)
    Body tinea 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Herpes zoster 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Pharyngitis 2/329 (0.6%) 0/300 (0%) 2/278 (0.7%) 0/329 (0%)
    Syphilis 2/329 (0.6%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Bronchitis viral 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Cellulitis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Hepatitis C 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Herpes simplex 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Influenza 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Nasopharyngitis 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Orchitis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Paronychia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Pharyngitis streptococcal 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Staphylococcal skin infection 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Urethritis 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Viral diarrhoea 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Viral upper respiratory tract infection 1/329 (0.3%) 3/300 (1%) 0/278 (0%) 0/329 (0%)
    Hordeolum 0/329 (0%) 2/300 (0.7%) 1/278 (0.4%) 0/329 (0%)
    Kidney infection 0/329 (0%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Acute sinusitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Balanitis candida 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Ear infection 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Genital herpes 0/329 (0%) 1/300 (0.3%) 1/278 (0.4%) 2/329 (0.6%)
    Giardiasis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Gonorrhoea 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Post viral fatigue syndrome 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Rhinitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Staphylococcal infection 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Tinea pedis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Urinary tract infection 0/329 (0%) 0/300 (0%) 2/278 (0.7%) 1/329 (0.3%)
    Abscess 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Fungal infection 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Keratitis herpetic 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Lobar pneumonia 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Salmonellosis 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Furuncle 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Pneumonia 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Scrotal abscess 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Respiratory tract infection 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Injury, poisoning and procedural complications
    Wrist fracture 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Alcohol poisoning 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Arthropod sting 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Contusion 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Ligament sprain 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Limb injury 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Thermal burn 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Tibia fracture 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Hand fracture 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Muscle strain 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 1/329 (0.3%)
    Spinal compression fracture 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Skeletal injury 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Procedural pain 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Investigations
    Anal pap smear abnormal 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Prostatic specific antigen increased 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Weight increased 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Blood pressure increased 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    CD4 lymphocytes decreased 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Electrocardiogram PR prolongation 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Liver function test abnormal 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Viral load increased 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Weight decreased 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Alanine aminotransferase increased 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Aspartate aminotransferase increased 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Blood creatinine increased 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Blood testosterone decreased 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hepatic enzyme increased 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Transaminases increased 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 1/329 (0.3%)
    Tuberculin test positive 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Metabolism and nutrition disorders
    Decreased appetite 2/329 (0.6%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Vitamin D deficiency 2/329 (0.6%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Hyperlipidaemia 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 2/329 (0.6%)
    Abnormal loss of weight 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Diabetes mellitus 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hypercholesterolaemia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hyperkalaemia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Iron deficiency 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Type 2 diabetes mellitus 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dehydration 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Hypomagnesaemia 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Musculoskeletal and connective tissue disorders
    Back pain 4/329 (1.2%) 4/300 (1.3%) 0/278 (0%) 3/329 (0.9%)
    Myalgia 4/329 (1.2%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Musculoskeletal pain 3/329 (0.9%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Osteoarthritis 2/329 (0.6%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Arthralgia 1/329 (0.3%) 4/300 (1.3%) 1/278 (0.4%) 1/329 (0.3%)
    Flank pain 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Muscle disorder 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Muscle spasms 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Muscular weakness 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Pain in extremity 1/329 (0.3%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Rotator cuff syndrome 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Trigger finger 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Joint range of motion decreased 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Myalgia intercostal 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Temporomandibular joint syndrome 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Tendonitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Femoroacetabular impingement 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Osteonecrosis 0/329 (0%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Skin papilloma 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Anogenital warts 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Oral neoplasm 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Melanocytic naevus 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Cervicitis human papilloma virus 0/329 (0%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Nervous system disorders
    Headache 9/329 (2.7%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Sinus headache 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Dizziness 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dysgeusia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Hypoaesthesia 1/329 (0.3%) 2/300 (0.7%) 0/278 (0%) 1/329 (0.3%)
    Migraine 1/329 (0.3%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Neuropathy peripheral 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Paraesthesia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 2/329 (0.6%)
    Amnesia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Cervicobrachial syndrome 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Sciatica 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Syncope 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 1/329 (0.3%)
    Tension headache 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Tremor 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Carpal tunnel syndrome 0/329 (0%) 0/300 (0%) 0/278 (0%) 2/329 (0.6%)
    Psychiatric disorders
    Depression 3/329 (0.9%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Anxiety 2/329 (0.6%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Sleep disorder 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Bipolar disorder 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Fear 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Insomnia 1/329 (0.3%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Panic attack 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Post-traumatic stress disorder 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Substance abuse 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Tobacco abuse 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Depression 0/329 (0%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Anxiety disorder 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Major depression 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Mental status changes 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Renal and urinary disorders
    Nephrolithiasis 1/329 (0.3%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Renal failure acute 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Renal failure chronic 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Cervical dysplasia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 1/329 (0.3%)
    Genital pain 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Genital rash 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Gynaecomastia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Menorrhagia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Prostatitis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Uterine cervical squamous metaplasia 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Erectile dysfunction 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Vulvar dysplasia 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Breast mass 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Epididymal cyst 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 6/329 (1.8%) 1/300 (0.3%) 3/278 (1.1%) 1/329 (0.3%)
    Nasal congestion 3/329 (0.9%) 2/300 (0.7%) 1/278 (0.4%) 0/329 (0%)
    Rhinitis allergic 3/329 (0.9%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Productive cough 2/329 (0.6%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dyspnoea 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Epistaxis 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Oropharyngeal pain 1/329 (0.3%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Pulmonary congestion 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Sinus congestion 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Sleep apnoea syndrome 1/329 (0.3%) 3/300 (1%) 0/278 (0%) 2/329 (0.6%)
    Upper-airway cough syndrome 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Wheezing 1/329 (0.3%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Respiratory tract congestion 0/329 (0%) 3/300 (1%) 1/278 (0.4%) 0/329 (0%)
    Asthma 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Bronchitis chronic 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 1/329 (0.3%)
    Chronic obstructive pulmonary disease 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 1/329 (0.3%)
    Skin and subcutaneous tissue disorders
    Rash 7/329 (2.1%) 4/300 (1.3%) 0/278 (0%) 1/329 (0.3%)
    Psoriasis 2/329 (0.6%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Idiopathic urticaria 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Skin exfoliation 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Skin ulcer 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Dermal cyst 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dermatitis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Dermatitis contact 0/329 (0%) 1/300 (0.3%) 1/278 (0.4%) 0/329 (0%)
    Eczema nummular 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Hyperkeratosis 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Ingrowing nail 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Papule 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Skin lesion 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Eczema 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Night sweats 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Urticaria 0/329 (0%) 0/300 (0%) 1/278 (0.4%) 0/329 (0%)
    Redness (Any) 9/162 (5.6%) 10/122 (8.2%) 10/105 (9.5%) 0/0 (NaN)
    Redness (Mild) 7/161 (4.3%) 8/120 (6.7%) 9/104 (8.7%) 0/0 (NaN)
    Redness (Moderate) 2/158 (1.3%) 2/117 (1.7%) 4/102 (3.9%) 0/0 (NaN)
    Redness (Severe) 0/157 (0%) 2/117 (1.7%) 1/101 (1%) 0/0 (NaN)
    Swelling (Any) 11/162 (6.8%) 16/126 (12.7%) 12/107 (11.2%) 0/0 (NaN)
    Swelling (Mild) 10/161 (6.2%) 15/125 (12%) 9/106 (8.5%) 0/0 (NaN)
    Swelling (Moderate) 1/158 (0.6%) 1/116 (0.9%) 4/102 (3.9%) 0/0 (NaN)
    Swelling (Severe) 1/158 (0.6%) 2/117 (1.7%) 1/101 (1%) 0/0 (NaN)
    Pain (Any) 205/260 (78.8%) 193/237 (81.4%) 167/204 (81.9%) 0/0 (NaN)
    Pain (Mild) 197/258 (76.4%) 181/230 (78.7%) 158/197 (80.2%) 0/0 (NaN)
    Pain (Moderate) 32/173 (18.5%) 50/150 (33.3%) 39/129 (30.2%) 0/0 (NaN)
    Pain (Severe) 2/158 (1.3%) 10/123 (8.1%) 6/105 (5.7%) 0/0 (NaN)
    Social circumstances
    Bereavement 0/329 (0%) 1/300 (0.3%) 0/278 (0%) 0/329 (0%)
    Vascular disorders
    Flushing 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Hot flush 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Hypertension 1/329 (0.3%) 2/300 (0.7%) 0/278 (0%) 0/329 (0%)
    Peripheral arterial occlusive disease 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)
    Peripheral vascular disorder 1/329 (0.3%) 0/300 (0%) 0/278 (0%) 0/329 (0%)

    Limitations/Caveats

    [Not Specified]

    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
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00963235
    Other Study ID Numbers:
    • 6115A1-3017
    • B1851028
    First Posted:
    Aug 21, 2009
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Apr 1, 2013