- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00918580
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
March 17, 2014 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 11361
- Pfizer Investigational Site
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Cairo, Egypt, 11511
- Pfizer Investigational Site
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Paris, France, 75015
- Pfizer Investigational Site
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Orbassano (TO), Italy, 10043
- Pfizer Investigational Site
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Roma, Italy, 00165
- Pfizer Investigational Site
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Beirut, Lebanon
- Pfizer Investigational Site
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Beirut, Lebanon, 2833-7401
- Pfizer Investigational Site
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Saudi
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Riyadh, Saudi, Saudi Arabia
- Pfizer Investigational Site
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London, United Kingdom, SE5 9RS
- Pfizer Investigational Site
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London, United Kingdom, SE1 9RT
- Pfizer Investigational Site
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London, United Kingdom, E1 1BB
- Pfizer Investigational Site
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London, United Kingdom, SE1 7RH
- Pfizer Investigational Site
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London, United Kingdom, SW17 0RE
- Pfizer Investigational Site
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Cheshire
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Manchester, Cheshire, United Kingdom, M27 4HA
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40202
- Pfizer Investigational Site
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Louisville, Kentucky, United States, 40202-3830
- Pfizer Investigational Site
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New York
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Bronx, New York, United States, 10467
- Pfizer Investigational Site
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Tennessee
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Nashville, Tennessee, United States, 37232
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
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2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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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
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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.
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Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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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
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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.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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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
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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.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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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
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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.
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1 year after 13vPnC Dose 2
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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
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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.
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Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Time Frame: 1 year after 13vPnC Dose 2
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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.
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1 year after 13vPnC Dose 2
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
Time Frame: Within 7 days after 13vPnC Dose 1
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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.
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Within 7 days after 13vPnC Dose 1
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Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
Time Frame: Within 7 days after 13vPnC Dose 2
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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.
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Within 7 days after 13vPnC Dose 2
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Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
Time Frame: Within 7 days after 13vPnC Dose 1
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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.
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Within 7 days after 13vPnC Dose 1
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Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
Time Frame: Within 7 days after 13vPnC Dose 2
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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.
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Within 7 days after 13vPnC Dose 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
June 9, 2009
First Submitted That Met QC Criteria
June 9, 2009
First Posted (ESTIMATE)
June 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 21, 2014
Last Update Submitted That Met QC Criteria
March 17, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-3014
- B1851013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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