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

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

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

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
Schwarzwaldstr. 18
Oberkirch, Germany, 77704
Christofstr.13A
Schwieberdingen, Germany, 71701
Schloß-Prunn-Str. 1
Munich, Germany, 81375
Germany, Baden-Württemberg
Hauptstrasse 240
Kehl, Baden-Württemberg, Germany, 77694
Wilhelmstrasse 25
Metzingen, Baden-Württemberg, Germany, 72555
Hauptstrasse 9
Bietigheim-Bissingen, Baden-Württemberg, Germany, 74321
Winckelhoferstrasse 3
Ehingen, Baden-Württemberg, Germany, 89584
Rheinstrasse 13
Ettenheim, Baden-Württemberg, Germany, 77955
Königstrasse 35
Rottweil, Baden-Württemberg, Germany, 78628
Crailsheimer Strasse 63
Schwäbisch Hall, Baden-Württemberg, Germany, 74523
Schwarzwaldstrasse 20
Kirchzarten, Baden-Württemberg, Germany, 79199
Werderstrasse 3
Bad Saulgau, Baden-Württemberg, Germany, 88348
Broner Platz 6
Weingarten, Baden-Württemberg, Germany, 88250
Flattichstrasse 29
Ludwigsburg, Baden-Württemberg, Germany, 71642
Grossbottwarer Strasse 47
Oberestenfeld, Baden-Württemberg, Germany, 71720
Bergstrasse 27
Rottweil, Baden-Württemberg, Germany, 78628
Bismarkstrasse 3
Ludwigsburg, Baden-Württemberg, Germany, 71634
Schillerstrasse 11
Tuttlinger, Baden-Württemberg, Germany, 78532
Kirchstrasse 2
Bönnigheim, Baden-Württemberg, Germany, 74357
Germany, Bayern (Bavaria)
Neuschwansteinstrasse 5
Augsburg, Bayern (Bavaria), Germany, 86163
Löpsingerstrasse 8
Nördlingen, Bayern (Bavaria), Germany, 86720
Bahnhofstrasse 13
Ebersberg, Bayern (Bavaria), Germany, 85560
Mohrenstrasse 8
Coburg, Bayern (Bavaria), Germany, 96450
Lehenstrasse 12
Bindlach, Bayern (Bavaria), Germany, 95463
Falkensteiner Strasse 24
Roding, Bayern (Bavaria), Germany, 93426
Germany, Rheinland-Pfalz
Langenbeckstrasse 1
Mainz, Rheinland-Pfalz, Germany, 55131
Germany, Thüringen
Goethestrasse 30
Arnstadt, Thüringen, Germany, 99310

Sponsors and Collaborators

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation ( Anna Kuc, Clinical Project Manager )
Study ID Numbers:	670701
Study First Received:	February 6, 2008
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00617760 History of Changes
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:

Bacterial Infections
Central Nervous System Infections
Nervous System Diseases
Meningitis, Bacterial

Central Nervous System Bacterial Infections
Central Nervous System Diseases
Meningitis

ClinicalTrials.gov processed this record on September 10, 2009