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

May 20, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • NeisVac-C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1 month after booster vaccination with PCV7
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
1 month after administration of MenC-TT vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 670701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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