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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01461980
First received: September 28, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Vaccines
Meningococcal Vaccines
Biological: rLP2086 + MCV4 + Tdap
Biological: MCV4 + Tdap + saline
Biological: rLP2086 + saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 > = to 10 Years to Less Than 13 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The hSBA geometric mean titers (GMTs) for each of the 2 primary strains (PMB80 [A22] and PMB2948 [B24]) at visit 6, among subjects in Groups 1 and 3. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The seroresponse rate at visit 2 for each of the 10 marketed vaccine antigens in Group 1 and Group 2. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects (Groups 1 and 2) who achieve an antibody level >=1.0 IU/mL to tetanus and proportion of subjects (Groups 1 and 2) who achieve an antibody level >1.0 IU/mL to diphtheria toxoid. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • hSBA titers as measured by GMTs for each of the 2 primary MnB test strains (PMB80 [A22] and PMB2948 [B24]) at each applicable blood sampling time point. [ Time Frame: Month 0, 1, 3, 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects with hSBA titers ≥LLOQ, ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64, ≥1:128 at each blood draw visit, for each of the 2 primary strains (PMB80 [A22] and PMB2948 [B24]). [ Time Frame: Month 0, 1, 3, 7 ] [ Designated as safety issue: No ]
  • Exploratory immunogenicity endpoints will be applied to MCV4 antigenic components in subjects from Group 1 and Group 2. The exploratory endpoints are IgG response (measured as GMCs) in serogroups A, C, Y and W-135. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1-month after the second and the third vaccination with the bivalent rLP2086 vaccine for each of the 2 primary strains (PMB80 [A22], PMB2948 [B24]). [ Time Frame: Month 3, 7 ] [ Designated as safety issue: No ]
  • Safety measured by subjects reporting adverse events and use of antipyretic medication. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]

Enrollment: 2657
Study Start Date: September 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCV4 + Tdap+ rLP2086
Group 1 - MCV4 + Tdap + rLP2086
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.
Active Comparator: MCV4 + Tdap + saline
Group 2, MCV4 + Tdap+ saline
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.
Placebo Comparator: Saline + saline + rLP2086
Group 3- rLP2086 + saline
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).

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461980

  Show 99 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01461980     History of Changes
Other Study ID Numbers: B1971015, 6108A1-2005
Study First Received: September 28, 2011
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
vaccine
rLP2086
MCV4
Tdap
meningitis B
N. meningitidis serogroup B
adolescents
observer-blind

ClinicalTrials.gov processed this record on September 16, 2014