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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • Cairo, Egypt, 11361
        • Pfizer Investigational Site
      • Cairo, Egypt, 11511
        • Pfizer Investigational Site
  • France
      • Paris, France, 75015
        • Pfizer Investigational Site
  • Italy
      • Orbassano (TO), Italy, 10043
        • Pfizer Investigational Site
      • Roma, Italy, 00165
        • Pfizer Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Pfizer Investigational Site
      • Beirut, Lebanon, 2833-7401
        • Pfizer Investigational Site
  • Saudi Arabia
    • Saudi
      • Riyadh, Saudi, Saudi Arabia
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • London, United Kingdom, E1 1BB
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 7RH
        • Pfizer Investigational Site
      • London, United Kingdom, SW17 0RE
        • Pfizer Investigational Site
    • Cheshire
      • Manchester, Cheshire, United Kingdom, M27 4HA
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202-3830
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 1
Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Names:
  • 13vPnC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
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.
Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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.
1 year after 13vPnC Dose 2
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.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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.
1 year after 13vPnC Dose 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 7 days after 13vPnC Dose 1
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.
Within 7 days after 13vPnC Dose 2
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.
Within 7 days after 13vPnC Dose 1
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.
Within 7 days after 13vPnC Dose 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6096A1-3014
  • B1851013

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