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Completed

NCT Number: NCT00617760

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

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.

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Key information

Conditions

Neisseria Meningitidis (Bacterial Meningitis) Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Infections Invasive Pneumococcal Disease (IPD) Meningitis Meningitis, Bacterial Nervous System Diseases Neuroinflammatory Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Werderstrasse 3, Bad Saulgau, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Other names: NeisVac-C and Prevenar®

7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)

Biological

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

Other names: Prevenar®

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

Biological

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

Other names: NeisVac-C

Primary outcomes

  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

    Time frame: 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

    Time frame: 1 month after administration of MenC-TT vaccine

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2008
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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