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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00617760
First received: February 6, 2008
Last updated: January 4, 2010
Last verified: January 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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 ]

Enrollment: 330
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Name: NeisVac-C and Prevenar®
Active Comparator: 2
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
Other Name: Prevenar®
Active Comparator: 3
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
Other Name: NeisVac-C

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

No publications provided

Responsible Party: Anna Kuc, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00617760     History of Changes
Other Study ID Numbers: 670701
Study First Received: February 6, 2008
Last Updated: January 4, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014