AzTrials
AzTrials

VaccinesPhase 2NCT01461980

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

A Phase 2 study testing rLP2086 + MCV4 + Tdap, MCV4 + Tdap + saline and rLP2086 + saline in people with Vaccines and Meningococcal Vaccines, run by Pfizer at 117 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Vaccines, Meningococcal Vaccines
What is being tested?
rLP2086 + MCV4 + Tdap, MCV4 + Tdap + saline and rLP2086 + saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,648 participants
Where
117 sitesUnited States
Study dates
28 Sep 2011to 8 May 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

117 sites in 1 country.

117 sites in 1 country

United States117 sites

  • Radiant Research, Inc

    Akron, Ohio, 44311

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Emory University School of Medicine Department of Pediatrics

    Atlanta, Georgia, 30322

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Radiant Research, Inc

    Atlanta, Georgia, 30342

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Radiant Research, Inc.

    Birmingham, Alabama, 35209

  • Internal Medicine & Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • PI-Coor Clinical Research, LLC

    Burke, Virginia, 22015

  • Clinical Research Advantage Inc/ East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Charleston Pediatrics

    Charleston, South Carolina, 29401

  • Pediatric Associates of Charlottesville, PLC

    Charlottesville, Virginia, 22902

  • Pediatric Associates of Charlottesville, PLC - West Satellite

    Charlottesville, Virginia, 22903

  • Pediatric Associates of Charlottesville, PLC - North Satellite

    Charlottesville, Virginia, 22911

  • Cincinnati Center for Clinical Research, Satellite Site - Clinic

    Cincinnati, Ohio, 45206

  • Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies

    Cincinnati, Ohio, 45229-3039

  • Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics

    Cleveland, Ohio, 44121

  • Senders Pediatrics

    Cleveland, Ohio, 44121

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Radiant Research

    Columbus, Ohio, 43212

  • Clinical Research Advantage, Inc./ Ridge Family Practice, PC

    Council Bluffs, Iowa, 51503

  • Office of Richard Ohnmacht

    Cranston, Rhode Island, 02920

  • Radiant Research, Inc.

    Dallas, Texas, 75231

  • North Georgia Clinical Research Center dba Whites Pediatrics

    Dalton, Georgia, 30721

  • Costal Clinical Research, Inc.

    Daphne, Alabama, 36526

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

  • Ohio Pediatrics, Inc.

    Dayton, Ohio, 45414

  • Northern Illinois Research Associates

    DeKalb, Illinois, 60115

  • Radiant Research, Inc.

    Denver, Colorado, 80239

  • Duke University Medical Center - Duke Health Center

    Durham, North Carolina, 27704

  • Durham Pediatrics

    Durham, North Carolina, 27704

  • Duke Health Center

    Durham, North Carolina, 27705

  • Child Health Care Associates

    East Syracuse, New York, 13057

  • Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice

    El Reno, Oklahoma, 73036

  • Innovis Health

    Fargo, North Dakota, 58103

  • Odyssey Research

    Fargo, North Dakota, 58104

  • Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC

    Fremont, Nebraska, 68025

  • Kaiser Permanente Fresno

    Fresno, California, 93726

  • Kaiser Permanente Hayward

    Hayward, California, 94545

  • Clinical Research Center of Nevada

    Henderson, Nevada, 89014

  • Advances in Health Research, Inc

    Houston, Texas, 77030

  • West Houston Clinical Research Service

    Houston, Texas, 77055

  • Pediatric Healthcare of Northwest Houston

    Houston, Texas, 77065

  • Pediatric Healthcare of Northwest Houston

    Houston, Texas, 77070

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Ohio Pediatrics, Inc.

    Huber Heights, Ohio, 45424

  • Pediatric Care Medical Group

    Huntington Beach, California, 92647

  • The Children's Clinic of Jonesboro, PA

    Jonesboro, Arkansas, 72401

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • Ohio Pediatric Research

    Kettering, Ohio, 45420

  • Gundersen Clinic, LTD

    La Crosse, Wisconsin, 54601

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89105

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68504

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Loma Linda University

    Loma Linda, California, 92350

  • Loma Linda University Health Care Pediatric Clinic

    Loma Linda, California, 92354

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • University of Louisville Pediatrics: Children and Youth Project

    Louisville, Kentucky, 40202

  • Brownsboro Park Pediatrics

    Louisville, Kentucky, 40207

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky, 40291

  • Pediatrics and Adolescent Medicine, PA

    Marietta, Georgia, 30062

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Clinical Research Advantage, Inc./Mesa Family Medical Center, PC

    Mesa, Arizona, 85203

  • Clinical Research Advantage, Inc./Desert

    Mesa, Arizona, 85213

  • Monroe Clinic

    Monroe, Wisconsin, 53566

  • Loma Linda University Health Care - Moreno Valley Pediatrics

    Moreno Valley, California, 92557

  • PMG Research of Charleson

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research, Inc.

    Murray, Utah, 84123

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Lynn Institute of Norman (LION)

    Norman, Oklahoma, 73069

  • Norwich Pediatric Group, P.C.

    Norwich, Connecticut, 06360

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Creighton Pediatric Infectious Diseases Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Bayview Research Group, LLC

    Paramount, California, 90723

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • PMG Research of Raleigh, LLC -

    Raleigh, North Carolina, 27609

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27612

  • Kaiser Permanente Sacramento

    Sacramento, California, 95815

  • Allina Health Bandana Square Clinic

    Saint Paul, Minnesota, 55108

  • Aspen Medical Group/ Odyssey Research

    Saint Paul, Minnesota, 55108

  • Aspen Medical Group

    Saint Paul, Minnesota, 55108

  • J. Lewis Resarch Incorporated, Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research Inc. - Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Child Care Associates

    San Antonio, Texas, 78212

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Radiant Research, Inc.

    San Antonio, Texas, 78229

  • First Steps Pediatrics

    San Antonio, Texas, 78254

  • California Research Foundation

    San Diego, California, 92103

  • J. Lewis Research, Inc. - Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Saint Louis University

    St Louis, Missouri, 63104

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Radiant Research, Inc.

    St Louis, Missouri, 63141

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Southwestern Medical Clinic Lakeland Healthcare Affiliate

    Stevensville, Michigan, 49127

  • University of South Florida

    Tampa, Florida, 33606

  • Pediatric Healthcare of Northwest Houston, PA

    Tomball, Texas, 77375

  • Pediatric Healthcare of Northwest Houston

    Tomball, Texas, 77375

  • Radiant Research, Inc.

    Tucson, Arizona, 85710

  • Radiant Research, Inc.

    Tucson, Arizona, 85712

  • Oklahoma State University - Center for Health Sciences - Pediatric Research

    Tulsa, Oklahoma, 74127

  • Bayview Research Group, LLC

    Valley Village, California, 91607

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • The Vancouver Clinic

    Vancouver, Washington, 98686

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Via Christi Clinic, P.A.

    Wichita, Kansas, 67208

  • Pediatrics and Adolescent Medicine

    Woodstock, Georgia, 30189

Other trials in United States

About this study

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

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.

Being tested
rLP2086 + MCV4 + Tdap, MCV4 + Tdap + saline, rLP2086 + saline
Keywords
vaccine, rLP2086, MCV4, Tdap, meningitis B, N. meningitidis serogroup B, adolescents, observer-blind

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rLP2086 + MCV4 + TdapBiological

    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.

  • MCV4 + Tdap + salineBiological

    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.

  • rLP2086 + salineBiological

    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 groups in NCT01461980
Study groupRoleWhat they receive
MCV4 + Tdap+ rLP2086Active comparatorGroup 1 - MCV4 + Tdap + rLP2086
Receives: Biological: rLP2086 + MCV4 + Tdap
MCV4 + Tdap + salineActive comparatorGroup 2, MCV4 + Tdap+ saline
Receives: Biological: MCV4 + Tdap + saline
Saline + saline + rLP2086Placebo comparatorGroup 3- rLP2086 + saline
Receives: Biological: rLP2086 + saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens

    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.

    Measured: 1 Month after Vaccination 1

  2. Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens

    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.

    Measured: 1 Month after Vaccination 1

  3. Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens

    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.

    Measured: 1 Month after Vaccination 1

  4. Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 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.

    Measured: 1 Month after Vaccination 3

Secondary outcomes (5)

  1. Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens

    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.

    Measured: 1 Month after Vaccination 1

  2. Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens

    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.

    Measured: 1 Month after Vaccination 1

  3. Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 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.

    Measured: Before Vaccination 1, 1 Month after Vaccination (Vac) 2

  4. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)

    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].

    Measured: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

  5. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

    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.

    Measured: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2011 (estimated)
  2. Study start28 Sep 2011
  3. Primary completion8 May 2014
  4. Study completion8 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461980
Sponsor's protocol ID
B1971015
Other IDs
6108A1-2005
Status last verified
Nov 2018
First submitted
28 Sep 2011
Last updated
20 Dec 2018
Data monitoring committee
Yes

Publications

  • Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

    PubMed 35164991

  • Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.

    PubMed 32681472

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rLP2086 + MCV4 + Tdap, MCV4 + Tdap + saline and rLP2086 + saline in people with Vaccines and Meningococcal Vaccines, run by Pfizer at 117 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens (time frame: 1 Month after Vaccination 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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