- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026038
Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
January 5, 2012 updated by: Pfizer
A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678).
In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine.
The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study.
This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
263
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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Ancenis, France, 44150
- Pfizer Investigational Site
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Bondues, France, 59910
- Pfizer Investigational Site
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Brest, France, 29200
- Pfizer Investigational Site
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Chalons En Champagne, France, 51100
- Pfizer Investigational Site
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Draguignan, France, 83300
- Pfizer Investigational Site
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Ecully, France, 69130
- Pfizer Investigational Site
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Essey Les Nancy, France, 54270
- Pfizer Investigational Site
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Floirac, France, 33270
- Pfizer Investigational Site
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Garges Les Gonesses, France, 95140
- Pfizer Investigational Site
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Joue Les Tours, France, 37300
- Pfizer Investigational Site
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Le Havre, France, 76600
- Pfizer Investigational Site
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Lingolsheim, France, 67380
- Pfizer Investigational Site
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Lyon, France, 69007
- Pfizer Investigational Site
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Maromme, France, 76150
- Pfizer Investigational Site
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Moutiers, France, 73600
- Pfizer Investigational Site
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Nancy, France, 54000
- Pfizer Investigational Site
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Nice, France, 06300
- Pfizer Investigational Site
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Olonne Sur Mer, France, 85340
- Pfizer Investigational Site
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Strasbourg, France, 67100
- Pfizer Investigational Site
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Strasbourg, France, 67000
- Pfizer Investigational Site
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Talence, France, 33400
- Pfizer Investigational Site
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Thionville, France, 57100
- Pfizer Investigational Site
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Tours, France, 37000
- Pfizer Investigational Site
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Villers Les Nancy, France, 54600
- Pfizer Investigational Site
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Vitry Sur Seine, France, 94400
- 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
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months
Exclusion Criteria:
- Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
- History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
1 dose (0.5 mL), IM of 13vPnC vaccine.
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All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine.
(at least 24 months after toddler dose).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine
Time Frame: One month after vaccination
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Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
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One month after vaccination
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Percentage of Participants With Prespecified Local Reactions
Time Frame: Seven days after vaccination
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Local reactions (redness, swelling and pain) were reported using electronic diary.
Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm.
Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units).
Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity.
Participants may be reported in more than 1 category.
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Seven days after vaccination
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Percentage of Participants With Prespecified Systemic Events
Time Frame: Seven days after vaccination
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Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary.
Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration).
Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day).
Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity).
Participants may be reported in more than 1 category.
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Seven days after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine
Time Frame: Up to 7 days before vaccination
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IgG GMC to 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 standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA).
CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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Up to 7 days before vaccination
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Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine
Time Frame: Four to seven days after vaccination
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IgG GMC to 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 standardized anti-pneumococcal IgG ELISA.
CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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Four to seven days after vaccination
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Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine
Time Frame: Up to 7 days before vaccination
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Pneumococcal OPA GMTs for 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.
CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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Up to 7 days before vaccination
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Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine
Time Frame: One month after vaccination
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Serotype-specific pneumococcal 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 mcOPA assay.
CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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One month after vaccination
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Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine
Time Frame: One month after vaccination
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Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.
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One month after vaccination
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Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine
Time Frame: One month after vaccination
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Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.
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One month after vaccination
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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
April 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 4, 2009
Study Record Updates
Last Update Posted (Estimate)
February 8, 2012
Last Update Submitted That Met QC Criteria
January 5, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6096A1-3021
- B1851016
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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