Clinical trial NCT00617760: Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis (Bacterial Meningitis)
Invasive Pneumococcal Disease (IPD)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: 1 month after booster vaccination with PCV7
measure: 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
timeFrame: 1 month after administration of MenC-TT vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Saulgau
country: Germany
facility: Werderstrasse 3
state: Baden-Württemberg
city: Bietigheim-Bissingen
country: Germany
facility: Hauptstrasse 9
state: Baden-Württemberg
city: Bönnigheim
country: Germany
facility: Kirchstrasse 2
state: Baden-Württemberg
city: Ehingen
country: Germany
facility: Winckelhoferstrasse 3
state: Baden-Württemberg
city: Ettenheim
country: Germany
facility: Rheinstrasse 13
state: Baden-Württemberg
city: Kehl
country: Germany
facility: Hauptstrasse 240
state: Baden-Württemberg
city: Kirchzarten
country: Germany
facility: Schwarzwaldstrasse 20
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
facility: Bismarkstrasse 3
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
facility: Flattichstrasse 29
state: Baden-Württemberg
city: Metzingen
country: Germany
facility: Wilhelmstrasse 25
state: Baden-Württemberg
city: Oberestenfeld
country: Germany
facility: Grossbottwarer Strasse 47
state: Baden-Württemberg
city: Rottweil
country: Germany
facility: Bergstrasse 27
state: Baden-Württemberg
city: Rottweil
country: Germany
facility: Königstrasse 35
state: Baden-Württemberg
city: Schwäbisch Hall
country: Germany
facility: Crailsheimer Strasse 63
state: Baden-Württemberg
city: Tuttlinger
country: Germany
facility: Schillerstrasse 11
state: Baden-Württemberg
city: Weingarten
country: Germany
facility: Broner Platz 6
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Neuschwansteinstrasse 5
state: Bayern (Bavaria)
city: Bindlach
country: Germany
facility: Lehenstrasse 12
state: Bayern (Bavaria)
city: Coburg
country: Germany
facility: Mohrenstrasse 8
state: Bayern (Bavaria)
city: Ebersberg
country: Germany
facility: Bahnhofstrasse 13
state: Bayern (Bavaria)
city: Nördlingen
country: Germany
facility: Löpsingerstrasse 8
state: Bayern (Bavaria)
city: Roding
country: Germany
facility: Falkensteiner Strasse 24
state: Bayern (Bavaria)
city: Mainz
country: Germany
facility: Langenbeckstrasse 1
state: Rheinland-Pfalz
city: Arnstadt
country: Germany
facility: Goethestrasse 30
state: Thüringen
city: Munich
country: Germany
facility: Schloß-Prunn-Str. 1
city: Oberkirch
country: Germany
facility: Schwarzwaldstr. 18
city: Schwieberdingen
country: Germany
facility: Christofstr.13A
Study officials:
References: