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

NCT ID: NCT00617760

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Neisseria Meningitidis (Bacterial Meningitis); Invasive Pneumococcal Disease (IPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects

Group Type: EXPERIMENTAL

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)

Intervention Type: BIOLOGICAL

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

PCV7 administration only, 85 subjects

Group Type: ACTIVE_COMPARATOR

7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)

Intervention Type: BIOLOGICAL

PCV7 (0.5 ml) to be administered in the right thigh muscle

3

MenC-TT vaccine only, 85 subjects

Group Type: ACTIVE_COMPARATOR

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)

Intervention Type: BIOLOGICAL

MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle

Interventions

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

Intervention Type: BIOLOGICAL

7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)

PCV7 (0.5 ml) to be administered in the right thigh muscle

Intervention Type: BIOLOGICAL

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)

MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle

Intervention Type: BIOLOGICAL

Other Intervention Names

NeisVac-C and Prevenar®; Prevenar®; NeisVac-C

Eligibility 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Werderstrasse 3

Bad Saulgau, Baden-Wurttemberg, Germany

Hauptstrasse 9

Bietigheim-Bissingen, Baden-Wurttemberg, Germany

Kirchstrasse 2

Bönnigheim, Baden-Wurttemberg, Germany

Winckelhoferstrasse 3

Ehingen, Baden-Wurttemberg, Germany

Rheinstrasse 13

Ettenheim, Baden-Wurttemberg, Germany

Hauptstrasse 240

Kehl, Baden-Wurttemberg, Germany

Schwarzwaldstrasse 20

Kirchzarten, Baden-Wurttemberg, Germany

Bismarkstrasse 3

Ludwigsburg, Baden-Wurttemberg, Germany

Flattichstrasse 29

Ludwigsburg, Baden-Wurttemberg, Germany

Wilhelmstrasse 25

Metzingen, Baden-Wurttemberg, Germany

Grossbottwarer Strasse 47

Oberestenfeld, Baden-Wurttemberg, Germany

Bergstrasse 27

Rottweil, Baden-Wurttemberg, Germany

Königstrasse 35

Rottweil, Baden-Wurttemberg, Germany

Crailsheimer Strasse 63

Schwäbisch Hall, Baden-Wurttemberg, Germany

Schillerstrasse 11

Tuttlinger, Baden-Wurttemberg, Germany

Broner Platz 6

Weingarten, Baden-Wurttemberg, Germany

Neuschwansteinstrasse 5

Augsburg, Bayern (Bavaria), Germany

Lehenstrasse 12

Bindlach, Bayern (Bavaria), Germany

Mohrenstrasse 8

Coburg, Bayern (Bavaria), Germany

Bahnhofstrasse 13

Ebersberg, Bayern (Bavaria), Germany

Löpsingerstrasse 8

Nördlingen, Bayern (Bavaria), Germany

Falkensteiner Strasse 24

Roding, Bayern (Bavaria), Germany

Langenbeckstrasse 1

Mainz, Rhineland-Palatinate, Germany

Goethestrasse 30

Arnstadt, Thuringia, Germany

Schloß-Prunn-Str. 1

Munich, , Germany

Schwarzwaldstr. 18

Oberkirch, , Germany

Christofstr.13A

Schwieberdingen, , Germany

Countries

Germany

Other Identifiers

670701

Identifier Type: -

Identifier Source: org_study_id