- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617760
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
May 20, 2015 updated by: Pfizer
Open-label, Randomized, 3-arm, Phase 3B Clinical Study to Investigate the Safety and Immunogenicity of a Concomitant Administration of Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate (MenC-TT) Vaccine and 7-valent Pneumococcal CRM197-conjugate Vaccine (PCV7) in Toddlers Previously Immunized During Infancy With PCV7
The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
330
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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Munich, Germany, 81375
- Schloß-Prunn-Str. 1
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Oberkirch, Germany, 77704
- Schwarzwaldstr. 18
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Schwieberdingen, Germany, 71701
- Christofstr.13A
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Baden-Württemberg
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Bad Saulgau, Baden-Württemberg, Germany, 88348
- Werderstrasse 3
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Bietigheim-Bissingen, Baden-Württemberg, Germany, 74321
- Hauptstrasse 9
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Bönnigheim, Baden-Württemberg, Germany, 74357
- Kirchstrasse 2
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Ehingen, Baden-Württemberg, Germany, 89584
- Winckelhoferstrasse 3
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Ettenheim, Baden-Württemberg, Germany, 77955
- Rheinstrasse 13
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Kehl, Baden-Württemberg, Germany, 77694
- Hauptstrasse 240
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Kirchzarten, Baden-Württemberg, Germany, 79199
- Schwarzwaldstrasse 20
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Ludwigsburg, Baden-Württemberg, Germany, 71634
- Bismarkstrasse 3
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Ludwigsburg, Baden-Württemberg, Germany, 71642
- Flattichstrasse 29
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Metzingen, Baden-Württemberg, Germany, 72555
- Wilhelmstrasse 25
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Oberestenfeld, Baden-Württemberg, Germany, 71720
- Grossbottwarer Strasse 47
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Rottweil, Baden-Württemberg, Germany, 78628
- Bergstrasse 27
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Rottweil, Baden-Württemberg, Germany, 78628
- Königstrasse 35
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Schwäbisch Hall, Baden-Württemberg, Germany, 74523
- Crailsheimer Strasse 63
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Tuttlinger, Baden-Württemberg, Germany, 78532
- Schillerstrasse 11
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Weingarten, Baden-Württemberg, Germany, 88250
- Broner Platz 6
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Bayern (Bavaria)
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Augsburg, Bayern (Bavaria), Germany, 86163
- Neuschwansteinstrasse 5
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Bindlach, Bayern (Bavaria), Germany, 95463
- Lehenstrasse 12
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Coburg, Bayern (Bavaria), Germany, 96450
- Mohrenstrasse 8
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Ebersberg, Bayern (Bavaria), Germany, 85560
- Bahnhofstrasse 13
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Nördlingen, Bayern (Bavaria), Germany, 86720
- Löpsingerstrasse 8
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Roding, Bayern (Bavaria), Germany, 93426
- Falkensteiner Strasse 24
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
- Langenbeckstrasse 1
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Thüringen
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Arnstadt, Thüringen, Germany, 99310
- Goethestrasse 30
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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
1 year to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if:
- they are toddlers, aged 12 to 18 months
- they are clinically healthy (i.e. the physician would have no reservations vaccinating with a MenC conjugate vaccine, and/or PCV7 outside the scope of a clinical trial)
- their parents/legal guardian(s) understand the nature of the study, agree to its provisions, and provide written informed consent
- their parents/legal guardian(s) agree to keep a Subject Diary
- they have received a complete primary series of pneumococcal conjugate vaccine (3 vaccinations with PCV7 in the first year of life according to the official vaccination calendar recommendations)
Exclusion Criteria:
Subjects will be excluded from participation in this study if:
- they have a history of any vaccine-related contraindicating event, e.g. serious reactions after first application of a PCV7 vaccine or high fever >= 40ºC associated with any vaccination, or generalized allergic reaction within 48 hours of a first application of vaccine
- they have a known sensitivity or allergy to any components of the vaccines
- they have previously been vaccinated with MenC vaccine
- they have already received a PCV 7 booster (4th vaccination)
- they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation
- they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
- they have a history of meningococcal serogroup C and/or invasive pneumococcal infection
- they have received any blood products or immunoglobulins within 90 days of study entry or the administration of such products is planned during the study period
- currently have or had a history of any serious disease (e.g. cardiac, renal, autoimmune, neurologic)
- were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- they or their parents /legal guardian(s) are in a dependent relationships with the study investigator or with a study team member. Dependent relationships include close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects
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MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle
Other Names:
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Active Comparator: 2
PCV7 administration only, 85 subjects
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PCV7 (0.5 ml) to be administered in the right thigh muscle
Other Names:
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Active Comparator: 3
MenC-TT vaccine only, 85 subjects
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MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects achieving PCV7-specific (elicited by each vaccine pneumococcal serotype) antibody concentrations of at least 0.2 mg/mL 1 month after a booster vaccination with PCV7
Time Frame: 1 month after booster vaccination with PCV7
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1 month after booster vaccination with PCV7
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Number of subjects achieving sero-protective levels of meningococcal serogroup C (MenC) specific serum bactericidal activity (SBA), defined as titer >=1:8, 1 month after administration of MenC-TT vaccine
Time Frame: 1 month after administration of MenC-TT vaccine
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1 month after administration of MenC-TT vaccine
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 6, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 18, 2008
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Central Nervous System Bacterial Infections
- Pneumococcal Infections
- Meningitis
- Meningitis, Bacterial
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- 670701
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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