A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01299480
First received: February 15, 2011
Last updated: November 28, 2012
Last verified: November 2012

February 15, 2011
November 28, 2012
March 2011
May 2012   (final data collection date for primary outcome measure)
The primary endpoint for the co-primary objectives are the proportion of subjects achieving an rLP2086-specific SBA titer >=1:4 , for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine (in groups 1 and 2). [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
The primary endpoint for the co-primary objectives are the proportion of subjects achieving an rLP2086-specific SBA titer >=1:4 , for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine (in groups 1 and 2). [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01299480 on ClinicalTrials.gov Archive Site
  • SBA titers for each of the 4 primary strains at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving an rLP2086-specific SBA titer 1:4, for each of the 4 primary strains, at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a 4-fold rise on rLP2086-specific SBA titer from baseline (day 1) to each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:8 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:16 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:32 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:64 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:128 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Fold-rise for the following: • Fold-rise from baseline to month 7; • Fold-rise from baseline to month 3; • Fold-rise from baseline to month 2. [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Incidence rates of local reactions, systemic events, use of anti-pyretic medication and unsolicted AEs/SAEs [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • SBA titers for each of the 4 primary strains at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving an rLP2086-specific SBA titer 1:4, for each of the 4 primary strains, at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a 4-fold rise on rLP2086-specific SBA titer from baseline (day 1) to each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:8 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:16 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:32 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:64 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:128 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Fold-rise for the following: • Fold-rise from baseline to month 7; • Fold-rise from baseline to month 3; • Fold-rise from baseline to month 2. [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
A Phase 2, Randomized, Placebo-Controlled, Single-Blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Meningococcal Vaccine
  • Biological: Vaccine
    rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
    Other Name: Group 1
  • Biological: Vaccine
    rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
    Other Name: Group 2
  • Biological: Vaccine
    rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
    Other Name: Group 3
  • Biological: Vaccine
    rLP2086 at visits 1 and 3, saline at visits 2 and 5
    Other Name: Group 4
  • Biological: Vaccine
    rLP2086 at visits 3 and 5, saline at visits 1 and 2
    Other Name: Group 5
  • Experimental: Group 1
    rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
    Intervention: Biological: Vaccine
  • Experimental: Group 2
    rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
    Intervention: Biological: Vaccine
  • Experimental: Group 3
    rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
    Intervention: Biological: Vaccine
  • Experimental: Group 4
    rLP2086 at visits 1 and 3, saline at visits 2 and 5
    Intervention: Biological: Vaccine
  • Experimental: Group 5
    rLP2086 at visits 3 and 5, saline at visits 1 and 2
    Intervention: Biological: Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1713
September 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
  • Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Male or female subject aged ≥11 and <19 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.
  • All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
  • Negative urine pregnancy test for female subjects.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
  • 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.
  • Participation in other studies during study participation. Participation in purely observational studies is acceptable.
  • Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration 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.
  • Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  • Subject is pregnant or breastfeeding.
  • Subject is a direct descendant of study site or Pfizer personnel
Both
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Denmark,   Finland,   Germany,   Poland,   Spain,   Sweden
 
NCT01299480
B1971012, 6108A1-2003
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP