Phase 2
N=2,648
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
Vaccines · Meningococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT01461980 ↗Enrolled (actual)
2,648
Serious AEs
1.3%
Results posted
May 2015
Primary outcome: Primary: Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens — 9.3; 9.8; 9.4; 10.3 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rLP2086 + MCV4 + Tdap (Biological); MCV4 + Tdap + saline (Biological); rLP2086 + saline (Biological)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens |
9.3; 9.8; 9.4; 10.3 | — |
| PRIMARY Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens |
13.2; 14.2; 112.0; 122.9; 202.0; 228.9 | — |
| PRIMARY Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens |
4647.3; 5113.0; 1679.2; 1650.2; 2212.6; 2244.9 | — |
| PRIMARY Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 |
45.9; 49.7; 24.8; 27.4 | — |
| SECONDARY Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens |
98.6; 98.3; 97.7; 97.4; 68.1; 72.7 | — |
| SECONDARY Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens |
99.1; 99.0; 98.1; 99.0 | — |
| SECONDARY Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 |
8.5; 8.6; 4.1; 4.2; 23.7; 23.8 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) |
4.4; 5.6; 68.0; 68.0; 87.5; 91.4 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level |
6.9; 7.5; 68.2; 68.6; 87.8; 91.7 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01461980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.