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Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

Last updated on June 7, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
ClinicalTrials.g[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Evidence of a personally signed and dated informed consent document (ICD) indicating
that the subject (or a legal representative) has been informed of all pertinent
aspects of the study.

2. Subjects who are willing and able to comply with scheduled visits, laboratory tests,
and other study procedures.

3. Subjects who completed a primary study and received all the scheduled injections
within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3
doses) or with investigational product in cases where subject vaccine assignment is
blinded at the time of consent for study B1971033.

4. Subjects who completed the blood draw following the last vaccination and subjects who
completed the 6-month follow-up telephone call in the primary study.

Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up):

1. Evidence of a personally signed and dated ICD indicating that the subject or subject's
parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10
of the booster stage of the study.

2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion
criteria.

3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination
study.

4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.

5. Subject is available for the entire period of the booster stage and the subject or
subject's parent(s)/legal guardian can be reached by telephone.

6. Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.

7. Male and female subjects of childbearing potential and at risk for pregnancy must
agree to use a highly effective method of contraception through Visit 10 of the
booster stage. A subject is of childbearing potential if, in the opinion of the
investigator, he/she is biologically capable of having children and is sexually
active. Refer to Section 4.5 for further information.

8. Negative urine pregnancy test for all female subjects on the day of the booster dose.

Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up):

1. For subject participating in Visit 11, evidence of a personally signed and dated ICD
indicating that the subject or subject's parent(s)/legal guardian has been informed of
all pertinent aspects of Visit 11.

2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion
criteria.

3. Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a
0-, 2-, and 6-month or a 0- and 6-month schedule.

4. Subject must have completed booster vaccination at Visit 7.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Subjects who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees directly involved in the conduct of
the trial.

2. With the exception of the primary study of bivalent rLP2086, participation in other
studies within the 1-month (30-day) period before study Visit 1 and/or during study
participation. Participation in purely observational studies is permitted.

3. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study.

4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate blood draw.

6. Receipt of any blood products, including gamma globulin, in the period from 6 months
before any study visit.

7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since
being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines
permitted in the primary study).

8. Subjects who were not compliant with primary study eligibility criteria while enrolled
in the primary study.

Exclusion Criteria for Booster Stage:

1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV)
vaccine as part of a 3-dose series during the 28 days after the booster vaccination.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

5. 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 in the
United States with terminal complement deficiency are excluded from participation in
this study. Please refer to the study reference manual (SRM) for additional details.

6. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).

7. Current chronic use of systemic antibiotics.

8. Current participation in another investigational study. Participation in purely
observational studies is acceptable.

9. Received any investigational vaccines, drugs, or devices within 28 days before
administration of the booster vaccination.

10. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

11. Pregnant female subjects, breastfeeding female subjects, male subjects with partners
who are currently pregnant, or male and female subjects of childbearing potential who
are unwilling or unable to use a highly effective method of contraception as outlined
in this protocol through Visit 10 of the study.

NCT01543087
Pfizer
Completed
Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

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Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
A Phase 3 Study To Assess The Persistence Of Hsba Response Up To 48 Months After Completion Of A Primary Series Of Bivalent Rlp2086, And The Safety, Tolerability, And Immunogenicity Of A Booster Dose Of Bivalent Rlp2086
This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.

This study is to assess the longevity of immune responses in adolescents (aged 10 to <19 years at the time of entry into a primary study) following receipt of a vaccination regimen of 2 or 3 doses of bivalent rLP2086 in a primary study. A booster dose of bivalent rLP2086 at approximately 48 months was given following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series. The study was therefore divided into Stage 1 (4-year persistence of immune responses following receipt of a primary vaccination series) and the booster stage (follow-up through 12 months for all boosted or 26 months for a subset of the boosted).

Subjects participating only in Stage 1 will attend up to 6 study visits for collection of a 20-mL blood sample at each visit. Subjects participating in both Stage 1 and booster stage will attend up to 9-10 study visits with 1 visit for booster dose vaccination and 8-9 visits for collection of a 20-mL blood sample at each visit.

Interventional
Phase 3
Masking: None (Open Label)
Primary Purpose: Other
Meningococcal Infection
  • Procedure: blood sampling
    Blood sample collection at different time points
  • Drug: bivalent rLP2086
    A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.
One group of subjects
Interventions:
  • Procedure: blood sampling
  • Drug: bivalent rLP2086
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
January 5, 2018
January 5, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria for Stage 1:

  1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
  3. Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for study B1971033.
  4. Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study.

Inclusion Criteria for Booster Stage Visits 7-10 (up to12 month post booster follow up):

  1. Evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study.
  2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
  3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.
  4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.
  5. Subject is available for the entire period of the booster stage and the subject or subject's parent(s)/legal guardian can be reached by telephone.
  6. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception through Visit 10 of the booster stage. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Refer to Section 4.5 for further information.
  8. Negative urine pregnancy test for all female subjects on the day of the booster dose.

Inclusion Criteria for Booster Stage Visit11 (26 month post booster follow up):

  1. For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11.
  2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
  3. Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-, 2-, and 6-month or a 0- and 6-month schedule.
  4. Subject must have completed booster vaccination at Visit 7.

Exclusion Criteria for Stage 1:

  1. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
  2. With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.
  3. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.
  6. Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.
  7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines permitted in the primary study).
  8. Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.

Exclusion Criteria for Booster Stage:

  1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV) vaccine as part of a 3-dose series during the 28 days after the booster vaccination.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. 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 in the United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.
  6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  7. Current chronic use of systemic antibiotics.
  8. Current participation in another investigational study. Participation in purely observational studies is acceptable.
  9. Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.
  10. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  11. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol through Visit 10 of the study.
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Czechia,   Denmark,   Finland,   Germany,   Sweden,   United States
Czech Republic,   Poland
 
NCT01543087
B1971033
2011-005697-31 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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