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

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Werderstrasse 3
Bad Saulgau, Baden-Württemberg, 88348 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neisseria Meningitidis (Bacterial Meningitis), Invasive Pneumococcal Disease (IPD)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-18 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00617760
Pfizer
Completed
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)

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Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Neisseria Meningitidis (Bacterial Meningitis)
  • Invasive Pneumococcal Disease (IPD)
Intervention  ICMJE
  • 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 Name: NeisVac-C and Prevenar®
  • Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
    PCV7 (0.5 ml) to be administered in the right thigh muscle
    Other Name: Prevenar®
  • 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 Name: NeisVac-C
Study Arms  ICMJE
  • Experimental: 1
    Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects
    Intervention: Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
  • Active Comparator: 2
    PCV7 administration only, 85 subjects
    Intervention: Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
  • Active Comparator: 3
    MenC-TT vaccine only, 85 subjects
    Intervention: Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
330
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2008)
340
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion DateAugust 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617760
Other Study ID Numbers  ICMJE 670701
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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