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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00918580
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.

Condition or disease Intervention/treatment Phase
Pneumococcal Conjugate Vaccine Biological: 13-valent Pneumoccocal Conjugate Vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine
Study Start Date : November 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Name: 13vPnC


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 [ Time Frame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2 ]
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.


Secondary Outcome Measures :
  1. Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 ]
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category.

  2. Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 [ Time Frame: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 ]
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.

  3. Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 ]
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.

  4. Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 ]
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category.

  5. Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 [ Time Frame: 1 year after 13vPnC Dose 2 ]
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category.

  6. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 ]
    Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category.

  7. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 [ Time Frame: 1 year after 13vPnC Dose 2 ]
    Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category.


Other Outcome Measures:
  1. Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 [ Time Frame: Within 7 days after 13vPnC Dose 1 ]
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here "Number of participants analyzed" signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.

  2. Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 [ Time Frame: Within 7 days after 13vPnC Dose 2 ]
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.

  3. Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 [ Time Frame: Within 7 days after 13vPnC Dose 1 ]
    Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.

  4. Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 [ Time Frame: Within 7 days after 13vPnC Dose 2 ]
    Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject between the ages of >=6 to <18 years.
  • Diagnosis of SCD
  • 23vPS vaccination at least 6 months prior to enrollment.

Exclusion Criteria:

  • Previous vaccination with pneumococcal conjugate vaccine.
  • Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918580


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202-3830
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Egypt
Pfizer Investigational Site
Cairo, Egypt, 11361
Pfizer Investigational Site
Cairo, Egypt, 11511
France
Pfizer Investigational Site
Paris, France, 75015
Italy
Pfizer Investigational Site
Orbassano (TO), Italy, 10043
Pfizer Investigational Site
Roma, Italy, 00165
Lebanon
Pfizer Investigational Site
Beirut, Lebanon, 2833-7401
Pfizer Investigational Site
Beirut, Lebanon
Saudi Arabia
Pfizer Investigational Site
Riyadh, Saudi, Saudi Arabia
United Kingdom
Pfizer Investigational Site
Manchester, Cheshire, United Kingdom, M27 4HA
Pfizer Investigational Site
London, United Kingdom, E1 1BB
Pfizer Investigational Site
London, United Kingdom, SE1 7RH
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00918580    
Other Study ID Numbers: 6096A1-3014
B1851013
First Posted: June 11, 2009    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn