Safety and Immunogencitiy Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®) - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00617760

Purpose

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.

Condition	Intervention	Phase
Neisseria Meningitidis (Bacterial Meningitis) Invasive Pneumococcal Disease (IPD)	Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)	Phase III

MedlinePlus related topics: Meningitis

Drug Information available for: Tetanus Vaccine Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	March 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects	Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) 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
2: Active Comparator PCV7 administration only, 85 subjects	Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) PCV7 (0.5 ml) to be administered in the right thigh muscle
3: Active Comparator MenC-TT vaccine only, 85 subjects	Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617760

Locations

Germany, Baden-Württemberg
Hauptstrasse 240	Recruiting
Kehl, Baden-Württemberg, Germany, 77694
Contact: Ulrich Behre, MD +49-7851-72001 praxis.u.behre@t-online.de
Principal Investigator: Ulrich Behre, MD
Wilhelmstrasse 25	Recruiting
Metzingen, Baden-Württemberg, Germany, 72555
Contact: Werner Deigendesch, MD +49-7123-9468-0 Werner.deigendesch@dgn.de
Principal Investigator: Werner Deigendesch, MD
Hauptstrasse 9	Recruiting
Bietigheim-Bissingen, Baden-Württemberg, Germany, 74321
Contact: Hans-Günther Döring, MD +49-7142-42056
Principal Investigator: Hans-Günther Döring, MD
Broner Platz 6	Recruiting
Weingarten, Baden-Württemberg, Germany, 88250
Contact: Lutz Hansen, MD +49-751-44094
Principal Investigator: Lutz Hansen, MD
Rheinstrasse 13	Recruiting
Ettenheim, Baden-Württemberg, Germany, 77955
Contact: Karola Kirsten, MD +49-7822-896860
Principal Investigator: Karola Kirsten, MD
Königstrasse 35	Recruiting
Rottweil, Baden-Württemberg, Germany, 78628
Contact: Joachim Kiehne, MD +49-741-13232
Principal Investigator: Joachim Kiehne, MD
Grossbottwarer Strasse 47	Not yet recruiting
Oberestenfeld, Baden-Württemberg, Germany, 71720
Contact: Martin Kimmig, MD +49-7062-3055 emkimmig@online.de
Principal Investigator: Martin Kimmig, MD
Schwarzwaldstrasse 20	Recruiting
Kirchzarten, Baden-Württemberg, Germany, 79199
Contact: Constanze Rehse, MD +49-7661-62266
Principal Investigator: Constanze Rehse, MD
Werderstrasse 3	Recruiting
Bad Saulgau, Baden-Württemberg, Germany, 88348
Contact: Michael Steiner, MD +49-7581-5370490
Principal Investigator: Michael Steiner, MD
Winckelhoferstrasse 3	Recruiting
Ehingen, Baden-Württemberg, Germany, 89584
Contact: Johannes Zimmer, MD +49-7391-71926
Principal Investigator: Johannes Zimmer, MD
Flattichstrasse 29	Not yet recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71642
Contact: Hella Hoffmann, MD +49-7141-504151 dr.hella.hoffmann@t-online.de
Principal Investigator: Hella Hoffmann
Crailsheimer Strasse 63	Recruiting
Schwäbisch Hall, Baden-Württemberg, Germany, 74523
Contact: Hermann Oesterle, MD +49-791-9325030
Principal Investigator: Hermann Oesterle, MD
Bergstrasse 27	Not yet recruiting
Rottweil, Baden-Württemberg, Germany, 78628
Contact: Hans-Ulrich Kraus, MD +49-741-7655
Principal Investigator: Hans-Ulrich Kraus, MD
Bismarkstrasse 3	Not yet recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71634
Contact: Renate Lang, MD +49-7141-924601 dr.renate.lang@dgn.de
Principal Investigator: Renate Lang, MD
Schillerstrasse 11	Not yet recruiting
Tuttlinger, Baden-Württemberg, Germany, 78532
Contact: Ralf Maier, MD +49-7461-966210 ralph-maier-tut@t-online.de
Principal Investigator: Ralf Maier, MD
Kirchstrasse 2	Not yet recruiting
Bönnigheim, Baden-Württemberg, Germany, 74357
Contact: Renate Mangelsdorf-Taxis, MD +49-7143-2904
Principal Investigator: Renate Mangelsdorf-Taxis, MD
Germany, Bayern (Bavaria)
Bahnhofstrasse 13	Recruiting
Ebersberg, Bayern (Bavaria), Germany, 85560
Contact: Bianka Koch, MD +49-8092-20585
Principal Investigator: Bianka Koch, MD
Löpsingerstrasse 8	Recruiting
Nördlingen, Bayern (Bavaria), Germany, 86720
Contact: Detlev Grunert, MD +49-9081-23105
Principal Investigator: Detlev Grunert, MD
Neuschwansteinstrasse 5	Recruiting
Augsburg, Bayern (Bavaria), Germany, 86163
Contact: Reiner Benckendorff, MD +49-821-63024
Principal Investigator: Reiner Benckendorff, MD
Mohrenstrasse 8	Recruiting
Coburg, Bayern (Bavaria), Germany, 96450
Contact: Klaus Schnell, MD +49-9561-94620 praxis@doc-schnell.de
Principal Investigator: Klaus Schnell, MD
Lehenstrasse 12	Not yet recruiting
Bindlach, Bayern (Bavaria), Germany, 95463
Contact: Norbert Meister, MD +49-9208-5040
Principal Investigator: Norbert Meister, MD
Falkensteiner Strasse 24	Not yet recruiting
Roding, Bayern (Bavaria), Germany, 93426
Contact: Victor von Arnim, MD +49-9461-3380
Principal Investigator: Victor von Arnim, MD
Germany, Rheinland-Pfalz
Langenbeckstrasse 1	Not yet recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Dorothee Kieninger, MD +49-06131-173090 kieninger@uni-mainz.de
Principal Investigator: Dorothee Kieninger
Germany, Thüringen
Goethestrasse 30	Recruiting
Arnstadt, Thüringen, Germany, 99310
Contact: Petra Baldauf, MD +49-3628-41517
Principal Investigator: Petra Baldauf, MD
Trommsdorffstrasse 10	Not yet recruiting
Rudolstadt, Thüringen, Germany, 07407
Contact: Birgit Raabe, MD +49-3672-342016
Principal Investigator: Birgit Raabe, MD

Sponsors and Collaborators

Baxter Healthcare Corporation

More Information

Responsible Party:	Baxter Healthcare Corporation ( Anna Kuc, Clinical Project Manager )
Study ID Numbers:	670701
Study First Received:	February 6, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00617760
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Bacterial Infections
Bacterial meningitis
Central Nervous System Infections
Meningitis, Bacterial

Central Nervous System Diseases
Neisseria meningitidis
Tetanus
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 14, 2009