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
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01461980
Collaborator
(none)
2,648
117
3
31.3
22.6
0.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2648 participants
Allocation:
Randomized
Masking:
Quadruple (Participant, Care Provider, 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 > = 10 To <13 Years
Actual Study Start Date
:
Sep 28, 2011
Actual Primary Completion Date
:
May 8, 2014
Actual Study Completion Date
:
May 8, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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).
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens [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 [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 [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 [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.
Secondary Outcome Measures
- Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens [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 [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 [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) [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 [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.
Other Outcome Measures
- Immunogloblulin G (IgG) Measured by GMC [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 [1 Month after Vaccination (Vac) 2, 3]
- Percentage of Participants With at Least One Adverse Event (AE) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radiant Research, Inc. | Birmingham | Alabama | United States | 35209 |
| 2 | Costal Clinical Research, Inc. | Daphne | Alabama | United States | 36526 |
| 3 | Clinical Research Advantage Inc/ East Valley Family Physicians, PLC | Chandler | Arizona | United States | 85224 |
| 4 | Radiant Research, Inc. | Chandler | Arizona | United States | 85224 |
| 5 | Clinical Research Advantage, Inc./Mesa Family Medical Center, PC | Mesa | Arizona | United States | 85203 |
| 6 | Clinical Research Advantage, Inc./Desert | Mesa | Arizona | United States | 85213 |
| 7 | Radiant Research, Inc. | Tucson | Arizona | United States | 85710 |
| 8 | Radiant Research, Inc. | Tucson | Arizona | United States | 85712 |
| 9 | The Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | United States | 72401 |
| 10 | Arkansas Pediatric Clinic | Little Rock | Arkansas | United States | 72205 |
| 11 | Kaiser Permanente Fresno | Fresno | California | United States | 93726 |
| 12 | Kaiser Permanente Hayward | Hayward | California | United States | 94545 |
| 13 | Pediatric Care Medical Group | Huntington Beach | California | United States | 92647 |
| 14 | Loma Linda University | Loma Linda | California | United States | 92350 |
| 15 | Loma Linda University Health Care Pediatric Clinic | Loma Linda | California | United States | 92354 |
| 16 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 17 | Loma Linda University Health Care - Moreno Valley Pediatrics | Moreno Valley | California | United States | 92557 |
| 18 | Bayview Research Group, LLC | Paramount | California | United States | 90723 |
| 19 | Center for Clinical Trials, LLC | Paramount | California | United States | 90723 |
| 20 | Kaiser Permanente Sacramento | Sacramento | California | United States | 95815 |
| 21 | California Research Foundation | San Diego | California | United States | 92103 |
| 22 | Bayview Research Group, LLC | Valley Village | California | United States | 91607 |
| 23 | Lynn Institute of the Rockies | Colorado Springs | Colorado | United States | 80907 |
| 24 | Colorado Springs Family Practice | Colorado Springs | Colorado | United States | 80909 |
| 25 | Radiant Research, Inc. | Denver | Colorado | United States | 80239 |
| 26 | Norwich Pediatric Group, P.C. | Norwich | Connecticut | United States | 06360 |
| 27 | University of South Florida | Tampa | Florida | United States | 33606 |
| 28 | Emory University School of Medicine Department of Pediatrics | Atlanta | Georgia | United States | 30322 |
| 29 | Emory University School of Medicine | Atlanta | Georgia | United States | 30322 |
| 30 | Radiant Research, Inc | Atlanta | Georgia | United States | 30342 |
| 31 | North Georgia Clinical Research Center dba Whites Pediatrics | Dalton | Georgia | United States | 30721 |
| 32 | Pediatrics and Adolescent Medicine, PA | Marietta | Georgia | United States | 30062 |
| 33 | Pediatrics and Adolescent Medicine | Woodstock | Georgia | United States | 30189 |
| 34 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
| 35 | Northern Illinois Research Associates | DeKalb | Illinois | United States | 60115 |
| 36 | Clinical Research Advantage, Inc./ Ridge Family Practice, PC | Council Bluffs | Iowa | United States | 51503 |
| 37 | Heartland Research Associates, LLC | Augusta | Kansas | United States | 67010 |
| 38 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
| 39 | Via Christi Clinic, P.A. | Wichita | Kansas | United States | 67208 |
| 40 | Kentucky Pediatric/Adult Research | Bardstown | Kentucky | United States | 40004 |
| 41 | University of Louisville Pediatrics: Children and Youth Project | Louisville | Kentucky | United States | 40202 |
| 42 | Brownsboro Park Pediatrics | Louisville | Kentucky | United States | 40207 |
| 43 | Bluegrass Clinical Research, Inc. | Louisville | Kentucky | United States | 40291 |
| 44 | Southwestern Medical Clinic Lakeland Healthcare Affiliate | Stevensville | Michigan | United States | 49127 |
| 45 | Allina Health Bandana Square Clinic | Saint Paul | Minnesota | United States | 55108 |
| 46 | Aspen Medical Group/ Odyssey Research | Saint Paul | Minnesota | United States | 55108 |
| 47 | Aspen Medical Group | Saint Paul | Minnesota | United States | 55108 |
| 48 | The Center for Pharmaceutical Research, PC | Kansas City | Missouri | United States | 64114 |
| 49 | Saint Louis University | Saint Louis | Missouri | United States | 63104 |
| 50 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
| 51 | Radiant Research, Inc. | Saint Louis | Missouri | United States | 63141 |
| 52 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
| 53 | Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC | Fremont | Nebraska | United States | 68025 |
| 54 | Midwest Children's Health Research Institute | Lincoln | Nebraska | United States | 68504 |
| 55 | Quality Clinical Research, Inc. | Omaha | Nebraska | United States | 68114 |
| 56 | Creighton Pediatric Infectious Diseases Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 57 | Clinical Research Center of Nevada | Henderson | Nevada | United States | 89014 |
| 58 | Clinical Research Center of Nevada | Las Vegas | Nevada | United States | 89105 |
| 59 | Child Health Care Associates | East Syracuse | New York | United States | 13057 |
| 60 | Duke University Medical Center - Duke Health Center | Durham | North Carolina | United States | 27704 |
| 61 | Durham Pediatrics | Durham | North Carolina | United States | 27704 |
| 62 | Duke Health Center | Durham | North Carolina | United States | 27705 |
| 63 | PMG Research of Raleigh, LLC - | Raleigh | North Carolina | United States | 27609 |
| 64 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27609 |
| 65 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27612 |
| 66 | Innovis Health | Fargo | North Dakota | United States | 58103 |
| 67 | Odyssey Research | Fargo | North Dakota | United States | 58104 |
| 68 | Radiant Research, Inc | Akron | Ohio | United States | 44311 |
| 69 | Cincinnati Center for Clinical Research, Satellite Site - Clinic | Cincinnati | Ohio | United States | 45206 |
| 70 | Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies | Cincinnati | Ohio | United States | 45229-3039 |
| 71 | Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics | Cleveland | Ohio | United States | 44121 |
| 72 | Senders Pediatrics | Cleveland | Ohio | United States | 44121 |
| 73 | Rapid Medical Research, Inc. | Cleveland | Ohio | United States | 44122 |
| 74 | Radiant Research | Columbus | Ohio | United States | 43212 |
| 75 | Ohio Pediatric Research Association | Dayton | Ohio | United States | 45414 |
| 76 | Ohio Pediatrics, Inc. | Dayton | Ohio | United States | 45414 |
| 77 | Ohio Pediatrics, Inc. | Huber Heights | Ohio | United States | 45424 |
| 78 | Ohio Pediatric Research | Kettering | Ohio | United States | 45420 |
| 79 | Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice | El Reno | Oklahoma | United States | 73036 |
| 80 | Lynn Institute of Norman (LION) | Norman | Oklahoma | United States | 73069 |
| 81 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 82 | Oklahoma State University - Center for Health Sciences - Pediatric Research | Tulsa | Oklahoma | United States | 74127 |
| 83 | Office of Richard Ohnmacht | Cranston | Rhode Island | United States | 02920 |
| 84 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 85 | Radiant Research, Inc. | Anderson | South Carolina | United States | 29621 |
| 86 | Charleston Pediatrics | Charleston | South Carolina | United States | 29401 |
| 87 | PMG Research of Charleson | Mount Pleasant | South Carolina | United States | 29464 |
| 88 | Internal Medicine & Pediatric Associates of Bristol, PC | Bristol | Tennessee | United States | 37620 |
| 89 | PMG Research of Bristol | Bristol | Tennessee | United States | 37620 |
| 90 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 91 | Tekton Research, Inc. | Austin | Texas | United States | 78745 |
| 92 | Radiant Research, Inc. | Dallas | Texas | United States | 75231 |
| 93 | Advances in Health Research, Inc | Houston | Texas | United States | 77030 |
| 94 | West Houston Clinical Research Service | Houston | Texas | United States | 77055 |
| 95 | Pediatric Healthcare of Northwest Houston | Houston | Texas | United States | 77065 |
| 96 | Pediatric Healthcare of Northwest Houston | Houston | Texas | United States | 77070 |
| 97 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
| 98 | Child Care Associates | San Antonio | Texas | United States | 78212 |
| 99 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 100 | Radiant Research, Inc. | San Antonio | Texas | United States | 78229 |
| 101 | First Steps Pediatrics | San Antonio | Texas | United States | 78254 |
| 102 | Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | United States | 77375 |
| 103 | Pediatric Healthcare of Northwest Houston | Tomball | Texas | United States | 77375 |
| 104 | Radiant Research, Inc. | Murray | Utah | United States | 84123 |
| 105 | J. Lewis Resarch Incorporated, Foothill Family Clinic | Salt Lake City | Utah | United States | 84109 |
| 106 | J. Lewis Research Inc. - Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
| 107 | Jean Brown Research | Salt Lake City | Utah | United States | 84124 |
| 108 | J. Lewis Research, Inc. - Jordan River Family Medicine | South Jordan | Utah | United States | 84095 |
| 109 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
| 110 | PI-Coor Clinical Research, LLC | Burke | Virginia | United States | 22015 |
| 111 | Pediatric Associates of Charlottesville, PLC | Charlottesville | Virginia | United States | 22902 |
| 112 | Pediatric Associates of Charlottesville, PLC - West Satellite | Charlottesville | Virginia | United States | 22903 |
| 113 | Pediatric Associates of Charlottesville, PLC - North Satellite | Charlottesville | Virginia | United States | 22911 |
| 114 | The Vancouver Clinic | Vancouver | Washington | United States | 98664 |
| 115 | The Vancouver Clinic | Vancouver | Washington | United States | 98686 |
| 116 | Gundersen Clinic, LTD | La Crosse | Wisconsin | United States | 54601 |
| 117 | Monroe Clinic | Monroe | Wisconsin | United States | 53566 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01461980
Other Study ID Numbers:
- B1971015
- 6108A1-2005
First Posted:
Oct 28, 2011
Last Update Posted:
Dec 20, 2018
Last Verified:
Nov 1, 2018
Keywords provided by Pfizer
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 |
|---|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Period Title: Overall Study | |||
| STARTED | 888 | 878 | 882 |
| Vaccination 1 | 884 | 870 | 875 |
| Vaccination 2 | 802 | 819 | 799 |
| Vaccination 3 | 757 | 777 | 748 |
| COMPLETED | 722 | 733 | 717 |
| NOT COMPLETED | 166 | 145 | 165 |
Baseline Characteristics
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | Total |
|---|---|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. | Total of all reporting groups |
| Overall Participants | 888 | 878 | 882 | 2648 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
10.6
(0.70)
|
10.6
(0.69)
|
10.6
(0.67)
|
10.6
(0.69)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
454
51.1%
|
427
48.6%
|
417
47.3%
|
1298
49%
|
| Male |
434
48.9%
|
451
51.4%
|
465
52.7%
|
1350
51%
|
Outcome Measures
| Title | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 778 | 780 |
| Diphtheria |
9.3
|
9.8
|
| Tetanus |
9.4
|
10.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 778 | 780 |
| Pertussis toxoid |
13.2
|
14.2
|
| Pertussis filamentous hemagglutinin |
112.0
|
122.9
|
| Pertussis pertactin |
202.0
|
228.9
|
| Pertussis fimbrial agglutinogens types 2+3 |
138.1
|
154.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMC Ratio |
| Estimated Value | 0.90 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population. Here, 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 779 | 781 |
| Serogroup A (N=763, 772) |
4647.3
|
5113.0
|
| Serogroup C (N=768, 767) |
1679.2
|
1650.2
|
| Serogroup Y (N=771, 770) |
2212.6
|
2244.9
|
| Serogroup W-135 (N=751, 765) |
5925.1
|
6367.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.82 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.89 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | Saline+Saline+rLP2086 |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 683 | 679 |
| PMB80 [A22] (N=679, 674) |
45.9
|
49.7
|
| PMB2948 [B24] (N=670, 656) |
24.8
|
27.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | PMB80 [A22]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MCV4+Tdap+rLP2086, MCV4+Tdap+Saline |
|---|---|---|
| Comments | PMB2948 [B24]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers). | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.90 | |
| Confidence Interval |
(2-Sided) 95% 0.82 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 779 | 781 |
| Diphtheria (N=774, 780) |
98.6
11.1%
|
98.3
11.2%
|
| Tetanus (N=774, 780) |
97.7
11%
|
97.4
11.1%
|
| Pertussis toxoid (N=774, 780) |
68.1
7.7%
|
72.7
8.3%
|
| Pertussis filamentous hemagglutinin (N=774, 780) |
85.3
9.6%
|
89.2
10.2%
|
| Pertussis pertactin (N=774, 780) |
96.0
10.8%
|
96.2
11%
|
| Pertussis fimbriae AG types 2+3 (N=774, 780) |
79.5
9%
|
81.9
9.3%
|
| Serogroup A (N=712, 736) |
85.4
9.6%
|
88.6
10.1%
|
| Serogroup C (N=738, 742) |
89.3
10.1%
|
88.9
10.1%
|
| Serogroup Y (N=754, 753) |
90.5
10.2%
|
93.6
10.7%
|
| Serogroup W-135 (N=729, 752) |
97.1
10.9%
|
97.2
11.1%
|
| Title | Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens |
|---|---|
| Description | 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. |
| Time Frame | 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 778 | 780 |
| Tetanus |
99.1
11.2%
|
99.0
11.3%
|
| Diphtheria |
98.1
11%
|
99.0
11.3%
|
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 |
|---|---|
| Description | 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. |
| Time Frame | Before Vaccination 1, 1 Month after Vaccination (Vac) 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 3 evaluable immunogenicity population. 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. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | Saline+Saline+rLP2086 |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 683 | 679 |
| Before Vaccination 1: PMB80 [A22] (N=677, 677) |
8.5
|
8.6
|
| Before Vaccination 1: PMB2948 [B24] (N=677, 676) |
4.1
|
4.2
|
| 1 Month after Vac 2: PMB80 [A22] (N=669, 665) |
23.7
|
23.8
|
| 1 Month after Vac 2: PMB2948 [B24] (N=656, 650) |
12.0
|
13.0
|
| Title | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) |
|---|---|
| Description | 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]. |
| Time Frame | Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 3 evaluable immunogenicity population. 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. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | Saline+Saline+rLP2086 |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 683 | 679 |
| Before Vaccination 1: PMB80[A22] 1:16 (N=677, 677) |
4.4
0.5%
|
5.6
0.6%
|
| 1 month after Vac 2: PMB80[A22] 1:16 (N= 669, 665) |
68.0
7.7%
|
68.0
7.7%
|
| 1 month after Vac 3: PMB80 [A22] 1:16 (N=679, 674) |
87.5
9.9%
|
91.4
10.4%
|
| Before Vaccination 1: PMB2948[B24] 1:8 (N=677,676) |
1.6
0.2%
|
3.4
0.4%
|
| 1 month after Vac 2: PMB2948[B24] 1:8 (N=656, 650) |
62.3
7%
|
66.0
7.5%
|
| 1 month after Vac 3: PMB2948[B24] 1:8 (N=670, 656) |
90.0
10.1%
|
92.7
10.6%
|
| Title | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level |
|---|---|
| Description | 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. |
| Time Frame | Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 3 evaluable immunogenicity population. 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. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | Saline+Saline+rLP2086 |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 683 | 679 |
| Before Vaccination 1: PMB80[A22] 1:4 (N=677,677) |
6.9
0.8%
|
7.5
0.9%
|
| 1 month after Vac 2: PMB80[A22] 1:4 (N=669, 665) |
68.2
7.7%
|
68.6
7.8%
|
| 1 month after Vac 3: PMB80[A22] 1:4 (N=679, 674) |
87.8
9.9%
|
91.7
10.4%
|
| Before Vaccination 1: PMB80[A22] 1:8 (N=677, 677) |
5.0
0.6%
|
6.4
0.7%
|
| 1 month after Vac 2: PMB80[A22] 1:8 (N=669, 665) |
68.2
7.7%
|
68.1
7.8%
|
| 1 month after Vac 3: PMB80[A22] 1:8 (N=679, 674) |
87.6
9.9%
|
91.5
10.4%
|
| Before Vaccination 1: PMB80[A22] 1:32 (N=677, 677) |
2.7
0.3%
|
3.2
0.4%
|
| 1 month after Vac 2: PMB80[A22] 1:32 (N=669, 665) |
55.0
6.2%
|
54.4
6.2%
|
| 1 month after Vac 3: PMB80[A22] 1:32 (N=679, 674) |
81.3
9.2%
|
84.7
9.6%
|
| Before Vaccination 1: PMB80[A22] 1:64 (N=677,677) |
0.7
0.1%
|
1.0
0.1%
|
| 1 month after Vac 2: PMB80[A22] 1:64 (N= 669, 665) |
25.6
2.9%
|
25.0
2.8%
|
| 1 month after Vac 3: PMB80[A22] 1:64 (N=679, 674) |
52.7
5.9%
|
55.6
6.3%
|
| Before Vaccination 1: PMB80[A22] 1:128 (N=677,677) |
0.1
0%
|
0.4
0%
|
| 1 month after Vac 2: PMB80[A22] 1:128 (N=669, 665) |
6.9
0.8%
|
7.5
0.9%
|
| 1 month after Vac 3: PMB80[A22] 1:128 (N=679, 674) |
23.6
2.7%
|
23.3
2.7%
|
| Before Vaccination 1: PMB2948[B24] 1:4 (N=677,676) |
2.1
0.2%
|
3.7
0.4%
|
| 1 month after Vac 2: PMB2948[B24] 1:4 (N=656, 650) |
64.8
7.3%
|
68.2
7.8%
|
| 1 month after Vac 3: PMB2948[B24] 1:4 (N=670, 656) |
90.7
10.2%
|
93.1
10.6%
|
| Before Vaccination 1: PMB2948[B24] 1:16(N=677,676) |
1.5
0.2%
|
2.1
0.2%
|
| 1 month after Vac 2: PMB2948[B24] 1:16(N=656,650) |
57.6
6.5%
|
60.3
6.9%
|
| 1 month after Vac 3: PMB2948[B24] 1:16(N=670,656) |
86.7
9.8%
|
88.9
10.1%
|
| Before Vaccination 1: PMB2948[B24] 1:32(N=677,676) |
0.4
0%
|
0.6
0.1%
|
| 1 month after Vac 2: PMB2948[B24] 1:32(N=656,650) |
26.2
3%
|
28.2
3.2%
|
| 1 month after Vac 3: PMB2948[B24] 1:32(N=670, 656) |
55.1
6.2%
|
60.7
6.9%
|
| Before Vaccination 1:PMB2948[B24] 1:64(N= 677,676) |
0.4
0%
|
0.3
0%
|
| 1 month after Vac 2: PMB2948[B24] 1:64 (N=656,650) |
8.7
1%
|
10.3
1.2%
|
| 1 month after Vac 3: PMB2948[B24] 1:64 (N=670,656) |
22.5
2.5%
|
24.1
2.7%
|
| Before Vaccination 1:PMB2948[B24] 1:128(N=677,676) |
0.1
0%
|
0.1
0%
|
| 1 month after Vac 2: PMB2948[B24] 1:128(N=656,650) |
2.4
0.3%
|
3.4
0.4%
|
| 1 month after Vac 3: PMB2948[B24] 1:128(N=670,656) |
6.6
0.7%
|
7.8
0.9%
|
| Title | Immunogloblulin G (IgG) Measured by GMC |
|---|---|
| Description | 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. |
| Time Frame | Before Vaccination 1, 1 Month after Vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 1 evaluable immunogenicity population. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. |
| Measure Participants | 779 | 781 |
| Before Vaccination 1: Serogroup A |
0.17
|
0.15
|
| 1 Month after Vaccination 1: Serogroup A |
11.42
|
11.38
|
| Before Vaccination 1: Serogroup C |
0.11
|
0.11
|
| 1 Month after Vaccination 1: Serogroup C |
5.59
|
5.47
|
| Before Vaccination 1: Serogroup Y |
0.14
|
0.13
|
| 1 Month after Vaccination 1: Serogroup Y |
2.49
|
2.14
|
| Before Vaccination 1: Serogroup W-135 |
0.13
|
0.13
|
| 1 Month after Vaccination 1: Serogroup W-135 |
1.79
|
1.84
|
| Title | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level |
|---|---|
| Description | |
| Time Frame | 1 Month after Vaccination (Vac) 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | Saline+Saline+rLP2086 |
|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 683 | 679 |
| 1 month after Vac 2 : PMB80 [A22] (N=663, 663) |
64.3
7.2%
|
63.7
7.3%
|
| 1 month after Vac 3 : PMB80 [A22] (N=673, 672) |
84.0
9.5%
|
88.7
10.1%
|
| 1 month after Vac 2 : PMB2948 [B24] (N=650, 647) |
56.3
6.3%
|
58.4
6.7%
|
| 1 month after Vac 3 : PMB2948 [B24] (N=664, 653) |
85.7
9.7%
|
87.7
10%
|
| Title | Percentage of Participants With at Least One Adverse Event (AE) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period. |
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 |
|---|---|---|---|
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. |
| Measure Participants | 883 | 870 | 875 |
| Vaccination phase: Adverse Events (N=883,870,875) |
42.9
4.8%
|
42.6
4.9%
|
46.2
5.2%
|
| Follow-up phase: Adverse Events (N=777,776,771) |
1.0
0.1%
|
0.5
0.1%
|
1.3
0.1%
|
Adverse Events
| Time Frame | AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment). | |||||
| Arm/Group Title | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | |||
| Arm/Group Description | Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. | Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. | |||
All Cause Mortality |
||||||
| MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/883 (1.7%) | 9/870 (1%) | 11/875 (1.3%) | |||
| Congenital, familial and genetic disorders | ||||||
| Adrenogenital syndrome | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Congenital spinal cord anomaly | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Gastrointestinal disorders | ||||||
| Pancreatitis acute | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Infections and infestations | ||||||
| Appendicitis | 1/883 (0.1%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Bone abscess | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Gastroenteritis | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Influenza | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Pneumonia | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Pneumonia viral | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Tooth abscess | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Concussion | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Epiphyseal fracture | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Excoriation | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Joint injury | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Radius fracture | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Wound secretion | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Type 1 diabetes mellitus | 0/883 (0%) | 1/870 (0.1%) | 1/875 (0.1%) | |||
| Diabetic ketoacidosis | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Hyperglycaemia | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Bone cyst | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Scoliosis | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Nervous system disorders | ||||||
| Convulsion | 0/883 (0%) | 1/870 (0.1%) | 1/875 (0.1%) | |||
| Dural arteriovenous fistula | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Hemiplegic migraine | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Migraine | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Syncope | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Cerebrovascular accident | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Psychiatric disorders | ||||||
| Affective disorder | 1/883 (0.1%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Depression suicidal | 0/883 (0%) | 1/870 (0.1%) | 0/875 (0%) | |||
| Disorientation | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Encopresis | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Post-traumatic stress disorder | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Psychogenic seizure | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Pneumomediastinum | 0/883 (0%) | 0/870 (0%) | 1/875 (0.1%) | |||
| Vascular disorders | ||||||
| Haemorrhage | 1/883 (0.1%) | 0/870 (0%) | 0/875 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 277/883 (31.4%) | 260/870 (29.9%) | 292/875 (33.4%) | |||
| Gastrointestinal disorders | ||||||
| Vomiting | 18/883 (2%) | 21/870 (2.4%) | 19/875 (2.2%) | |||
| Nausea | 10/883 (1.1%) | 9/870 (1%) | 14/875 (1.6%) | |||
| Abdominal pain | 2/883 (0.2%) | 7/870 (0.8%) | 10/875 (1.1%) | |||
| General disorders | ||||||
| Injection site pain | 19/883 (2.2%) | 21/870 (2.4%) | 15/875 (1.7%) | |||
| Pyrexia | 20/883 (2.3%) | 14/870 (1.6%) | 17/875 (1.9%) | |||
| Infections and infestations | ||||||
| Upper respiratory tract infection | 47/883 (5.3%) | 61/870 (7%) | 70/875 (8%) | |||
| Pharyngitis | 38/883 (4.3%) | 27/870 (3.1%) | 28/875 (3.2%) | |||
| Pharyngitis streptococcal | 23/883 (2.6%) | 20/870 (2.3%) | 30/875 (3.4%) | |||
| Nasopharyngitis | 22/883 (2.5%) | 19/870 (2.2%) | 16/875 (1.8%) | |||
| Gastroenteritis viral | 15/883 (1.7%) | 15/870 (1.7%) | 25/875 (2.9%) | |||
| Gastroenteritis | 15/883 (1.7%) | 20/870 (2.3%) | 16/875 (1.8%) | |||
| Sinusitis | 18/883 (2%) | 13/870 (1.5%) | 17/875 (1.9%) | |||
| Otitis media | 17/883 (1.9%) | 11/870 (1.3%) | 14/875 (1.6%) | |||
| Bronchitis | 5/883 (0.6%) | 6/870 (0.7%) | 15/875 (1.7%) | |||
| Viral infection | 4/883 (0.5%) | 7/870 (0.8%) | 12/875 (1.4%) | |||
| Conjunctivitis | 9/883 (1%) | 6/870 (0.7%) | 3/875 (0.3%) | |||
| Otitis externa | 17/883 (1.9%) | 11/870 (1.3%) | 14/875 (1.6%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall | 12/883 (1.4%) | 13/870 (1.5%) | 16/875 (1.8%) | |||
| Ligament sprain | 12/883 (1.4%) | 12/870 (1.4%) | 13/875 (1.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Pain in extremity | 9/883 (1%) | 4/870 (0.5%) | 8/875 (0.9%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Skin papilloma | 9/883 (1%) | 2/870 (0.2%) | 3/875 (0.3%) | |||
| Nervous system disorders | ||||||
| Headache | 24/883 (2.7%) | 29/870 (3.3%) | 26/875 (3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 26/883 (2.9%) | 20/870 (2.3%) | 31/875 (3.5%) | |||
| Oropharyngeal pain | 17/883 (1.9%) | 13/870 (1.5%) | 23/875 (2.6%) | |||
| Nasal congestion | 4/883 (0.5%) | 5/870 (0.6%) | 11/875 (1.3%) | |||
| Rhinitis allergic | 6/883 (0.7%) | 4/870 (0.5%) | 10/875 (1.1%) | |||
| Asthma | 6/883 (0.7%) | 4/870 (0.5%) | 9/875 (1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis contact | 11/883 (1.2%) | 1/870 (0.1%) | 5/875 (0.6%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01461980
Other Study ID Numbers:
- B1971015
- 6108A1-2005
First Posted:
Oct 28, 2011
Last Update Posted:
Dec 20, 2018
Last Verified:
Nov 1, 2018