Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617760
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Neisseria Meningitidis (Bacterial Meningitis) Invasive Pneumococcal Disease (IPD) Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) Biological: 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) Biological: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: NeisVac-C




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617760


Locations
Show Show 27 study locations
Sponsors and Collaborators
Pfizer
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00617760    
Other Study ID Numbers: 670701
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumococcal Infections
Meningitis, Bacterial
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs