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Neisseria Meningitidis (Bacterial Meningitis)Phase 3NCT00617760

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

A Phase 3 study testing Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) and Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) in people with Neisseria Meningitidis (Bacterial Meningitis) and Invasive Pneumococcal Disease (IPD), run by Pfizer at 27 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 monthsHealthy volunteers can take part
What is being tested?
Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) and Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
27 sitesGermany
Study dates
Mar 2008to Dec 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites

  • Goethestrasse 30

    Arnstadt, Thuringia, 99310

  • Neuschwansteinstrasse 5

    Augsburg, Bayern (Bavaria), 86163

  • Werderstrasse 3

    Bad Saulgau, Baden-Wurttemberg, 88348

  • Hauptstrasse 9

    Bietigheim-Bissingen, Baden-Wurttemberg, 74321

  • Lehenstrasse 12

    Bindlach, Bayern (Bavaria), 95463

  • Kirchstrasse 2

    Bönnigheim, Baden-Wurttemberg, 74357

  • Mohrenstrasse 8

    Coburg, Bayern (Bavaria), 96450

  • Bahnhofstrasse 13

    Ebersberg, Bayern (Bavaria), 85560

  • Winckelhoferstrasse 3

    Ehingen, Baden-Wurttemberg, 89584

  • Rheinstrasse 13

    Ettenheim, Baden-Wurttemberg, 77955

  • Hauptstrasse 240

    Kehl, Baden-Wurttemberg, 77694

  • Schwarzwaldstrasse 20

    Kirchzarten, Baden-Wurttemberg, 79199

  • Bismarkstrasse 3

    Ludwigsburg, Baden-Wurttemberg, 71634

  • Flattichstrasse 29

    Ludwigsburg, Baden-Wurttemberg, 71642

  • Langenbeckstrasse 1

    Mainz, Rhineland-Palatinate, 55131

  • Wilhelmstrasse 25

    Metzingen, Baden-Wurttemberg, 72555

  • Schloß-Prunn-Str. 1

    Munich, 81375

  • Löpsingerstrasse 8

    Nördlingen, Bayern (Bavaria), 86720

  • Grossbottwarer Strasse 47

    Oberestenfeld, Baden-Wurttemberg, 71720

  • Schwarzwaldstr. 18

    Oberkirch, 77704

  • Falkensteiner Strasse 24

    Roding, Bayern (Bavaria), 93426

  • Bergstrasse 27

    Rottweil, Baden-Wurttemberg, 78628

  • Königstrasse 35

    Rottweil, Baden-Wurttemberg, 78628

  • Crailsheimer Strasse 63

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • Christofstr.13A

    Schwieberdingen, 71701

  • Schillerstrasse 11

    Tuttlinger, Baden-Wurttemberg, 78532

  • Broner Platz 6

    Weingarten, Baden-Wurttemberg, 88250

Other trials in Germany

About this 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

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.

Being tested
Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)
Medical subject headings
Meningitis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called NeisVac-C and Prevenar®

    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

  • 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)Biological

    Also called Prevenar®

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

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

    Also called NeisVac-C

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

Study groups in NCT00617760
Study groupRoleWhat they receive
1ExperimentalConcomitant administration of MenC-TT vaccine and PCV7, 170 subjects
Receives: Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
2Active comparatorPCV7 administration only, 85 subjects
Receives: Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
3Active comparatorMenC-TT vaccine only, 85 subjects
Receives: Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month after booster vaccination with PCV7

  2. 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

    Measured: 1 month after administration of MenC-TT vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionAug 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617760
Sponsor's protocol ID
670701
Status last verified
May 2015
First submitted
6 Feb 2008
Last updated
21 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) and Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) in people with Neisseria Meningitidis (Bacterial Meningitis) and Invasive Pneumococcal Disease (IPD), run by Pfizer at 27 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 1 month after booster vaccination with PCV7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00617760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.

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