A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01352793
First received: May 11, 2011
Last updated: February 25, 2015
Last verified: February 2015
  Purpose

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.


Condition Intervention Phase
Meningitis, Meningococcal
Biological: rLP2086 vaccine
Biological: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study [ Time Frame: Vaccination 1 up to 6 months after Vaccination 3 ] [ Designated as safety issue: Yes ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.

  • Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 [ Time Frame: Within 30 days after Vaccination 1 ] [ Designated as safety issue: Yes ]
    A medically attended AE was defined as a non-serious AE that required medical attention.

  • Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 [ Time Frame: Within 30 days after Vaccination 2 ] [ Designated as safety issue: Yes ]
    A medically attended AE was defined as a non-serious AE that required medical attention.

  • Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 [ Time Frame: Within 30 days after Vaccination 3 ] [ Designated as safety issue: Yes ]
    A medically attended AE was defined as a non-serious AE that required medical attention.


Secondary Outcome Measures:
  • Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  • Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods [ Time Frame: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) ] [ Designated as safety issue: Yes ]
    A medically attended AE was defined as a non-serious AE that required medical attention.

  • Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) ] [ Designated as safety issue: Yes ]
    A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  • Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  • Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination [ Time Frame: Within 30 minutes after Vaccination 1, 2, 3 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

  • Number of Days Participant Missed School or Work Due to Adverse Events (AEs) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ] [ Designated as safety issue: Yes ]

Enrollment: 5715
Study Start Date: November 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086 vaccine
rLP2086 vaccine
Biological: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.
control
The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Biological: control
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

  • Previous vaccination with Hepatitis A virus vaccine
  • Previous vaccination with investigational meningococcal B vaccine
  • History of culture-proven N. meningitidis serogroup B disease
  • Any neuroinflammatory or autoimmune condition
  • Any immune defect that would prevent an effective response to the study vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352793

  Show 86 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01352793     History of Changes
Other Study ID Numbers: B1971014, 2009-015198-11, 6108A1-3003
Study First Received: May 11, 2011
Results First Received: February 25, 2015
Last Updated: February 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
phase 3 safety study
5700 healthy subjects
3 vaccine doses at month 0
2
and 6
control HAV/saline/HAV

Additional relevant MeSH terms:
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on March 31, 2015