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Trial record 1 of 1 for:    NCT01461980
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A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

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ClinicalTrials.gov Identifier: NCT01461980
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : May 25, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 28, 2011
First Posted Date  ICMJE October 28, 2011
Results First Submitted Date  ICMJE May 7, 2015
Results First Posted Date  ICMJE May 25, 2015
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE September 28, 2011
Actual Primary Completion Date May 8, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens [ Time Frame: 1 Month after Vaccination 1 ]
    Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
  • Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens [ Time Frame: 1 Month after Vaccination 1 ]
    Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
  • Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens [ Time Frame: 1 Month after Vaccination 1 ]
    Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
  • Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 [ Time Frame: 1 Month after Vaccination 3 ]
    Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • The geometric mean titers (GMTs) or geometric mean concentrations (GMCs) for each of the antibodies reactive with each of the 10 antigenic components in the marketed vaccines at visit 2, among subjects in Groups 1 and 2. [ Time Frame: Month 1 ]
  • The hSBA geometric mean titers (GMTs) for each of the 2 primary strains at visit 6, among subjects in Groups 1 and 3. [ Time Frame: Month 7 ]
Change History Complete list of historical versions of study NCT01461980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens [ Time Frame: 1 Month after Vaccination 1 ]
    Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.
  • Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens [ Time Frame: 1 Month after Vaccination 1 ]
    Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.
  • Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2 ]
    Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.
  • Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 ]
    Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].
  • Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 ]
    Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • Immunogenicity measured by the proportion of subjects achieving hSBA titers greater than or equal to 1:4, 1 month after the second and third vaccination of rLP2086 for each of the 2 primary strains in Group 1 and Group 3. [ Time Frame: Months 3 and 7 ]
  • Immunogenicity measured by the seroresponse rate at visit 2 for each of the 10 marketed vaccine antigens in Group 1 and Group 2. [ Time Frame: Month 1 ]
  • Immunogenicity measured by the hSBA titers measured by GMTs for each of the 2 primary strains among subjects in Groups 1 and 3. [ Time Frame: Month 3 ]
  • Immunogenicity measured by the proportion of subjects (Groups 1 and 2) who achieve an antibody level greater than or equal to 1.0 IU/mL to tetanus [ Time Frame: Month 1 ]
  • Immunogenicity measured by the proportion of subjects (Groups 1 and 2) who achieve an antibody level greater than or equal to 1.0 IU/mL to diphtheria toxoid. [ Time Frame: Month 1 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers below lower limit of quantitation (LLOQ) at each applicable blood sampling time point for each of the 2 primary strains. [ Time Frame: Months 0, 3, and 7 ]
  • Immunogenicity measured by the proportion of subjects achieving at least 4 fold rise on hSBA titer for each of the 2 primary strains. [ Time Frame: Months 0, 3 and 7 ]
  • Immunogenicity measured by the hSBA titers measured by GMTs for each of the 2 primary strains at each applicable blood sampling time point. [ Time Frame: Months 0, 1, 3, and 7 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers greater than or equal to 1:4 at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 0, 1, 3 and 7 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers greater than or equal to 1:8 at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 0, 1, 3 and 7 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers greater than or equal to 1:16, at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 1, 3, & 7 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers greater than or equal to 1:32, at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 0 to 7 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers greater than or equal to 1:64, at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 0 to 3 ]
  • Immunogenicity measured by the proportion of subjects with hSBA titers 1 greater than or equal to 1:28, at each blood draw visit, for each of the 2 primary strains. [ Time Frame: Months 0 to 3 ]
  • Immunogenicity measured by the geometric mean fold rise (GMFR) from Visit 1 to Visit 6 (postvaccination 3 relative to baseline) on hSBA titer for each of the 2 primary strains. [ Time Frame: Months 0,2,and 6 ]
  • Immunogenicity measured by the geometric mean fold rise (GMFR) from Visit 1 to Visit 4 (postvaccination 2 relative to baseline) on hSBA titer for each of the 2 primary strains. [ Time Frame: Months 0,1,and 3 ]
  • Safety measured by subjects reporting adverse events. [ Time Frame: Months 0 to 12 ]
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2015)
  • Immunogloblulin G (IgG) Measured by GMC [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1 ]
    IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.
  • Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level [ Time Frame: 1 Month after Vaccination (Vac) 2, 3 ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3) ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Official Title  ICMJE A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
Brief Summary This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Vaccines
  • Meningococcal Vaccines
Intervention  ICMJE
  • Biological: rLP2086 + MCV4 + Tdap
    At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
  • Biological: MCV4 + Tdap + saline
    At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
  • Biological: rLP2086 + saline
    At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Study Arms  ICMJE
  • Active Comparator: MCV4 + Tdap+ rLP2086
    Group 1 - MCV4 + Tdap + rLP2086
    Intervention: Biological: rLP2086 + MCV4 + Tdap
  • Active Comparator: MCV4 + Tdap + saline
    Group 2, MCV4 + Tdap+ saline
    Intervention: Biological: MCV4 + Tdap + saline
  • Placebo Comparator: Saline + saline + rLP2086
    Group 3- rLP2086 + saline
    Intervention: Biological: rLP2086 + saline
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: May 7, 2015)
2648
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
2625
Actual Study Completion Date  ICMJE May 8, 2014
Actual Primary Completion Date May 8, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
  • Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
  • Male or female subject aged greater than or equal to 10 and <13 years at the time of enrollment.
  • Available for the entire study period and can be reached by telephone.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
  • Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
  • Previous vaccination with any MCV4 vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with MCV4 and/or Tdap vaccine.
  • Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
  • Current chronic use of systemic antibiotics.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461980
Other Study ID Numbers  ICMJE B1971015
6108A1-2005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP