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A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01830855
First received: April 3, 2013
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Condition Intervention Phase
Meningococcal Vaccine
Biological: rLP2086
Biological: Havrix (HAV)
Biological: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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 Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 [ Time Frame: One month after third bivalent rLP2086 vaccination ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.

  • hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine [ Time Frame: One month after third bivalent rLP2086 vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination [ Time Frame: Within 7 Days after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination [ Time Frame: Within 7 Days after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination [ Time Frame: Within 7 Days after third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination [ Time Frame: Within 7 Days after first vaccination ] [ Designated as safety issue: Yes ]
    Here, N signifies participants with known values reporting specific characteristic.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination [ Time Frame: Within 7 Days after second vaccination ] [ Designated as safety issue: Yes ]
    Here, N signifies participants with known values reporting specific characteristic.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination [ Time Frame: Within 7 Days after third vaccination ] [ Designated as safety issue: Yes ]
    Here, N signifies participants with known values reporting specific characteristic.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination [ Time Frame: Within 30 days after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination [ Time Frame: Within 30 days after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination [ Time Frame: Within 30 days after third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase [ Time Frame: From the first vaccination up to 1 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase [ Time Frame: From 1 month after third vaccination up to 6 months after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period [ Time Frame: From the first vaccination up to 6 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination [ Time Frame: Within 30 days after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination [ Time Frame: Within 30 days after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination [ Time Frame: Within 30 days after third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase [ Time Frame: From the first vaccination up to 1 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase [ Time Frame: From 1 month after third vaccination up to 6 months after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period [ Time Frame: From the first vaccination up to 6 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination [ Time Frame: Within 30 days after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination [ Time Frame: 30 days after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination [ Time Frame: Within 30 days after third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination [ Time Frame: Within 30 Days After any Vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase [ Time Frame: From the first vaccination up to 1 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase [ Time Frame: From 1 month after third vaccination up to 6 months after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period [ Time Frame: From the first vaccination up to 6 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination [ Time Frame: Within 30 days after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination [ Time Frame: Within 30 days after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination [ Time Frame: Within 30 days after third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination [ Time Frame: Within 30 Days after any vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase [ Time Frame: From the first vaccination up to 1 month after the third vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination [ Time Frame: Within 30 minutes after first vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination [ Time Frame: Within 30 minutes after second vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination [ Time Frame: Within 30 minutes after third vaccination ] [ Designated as safety issue: Yes ]
  • Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase [ Time Frame: From the first vaccination up to 1 month after the third vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 [ Time Frame: Before first vaccination, 1 month after third vaccination ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

  • Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 [ Time Frame: Before first vaccination, 1 month after third vaccination (Vac) ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

  • hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 [ Time Frame: Before first vaccination, 1 month after third vaccination ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

  • Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 [ Time Frame: Before vaccination 1, 1 Month after Vaccination 2 ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

  • Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 [ Time Frame: One month after second Bivalent rLP2086 vaccination ] [ Designated as safety issue: No ]
    Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

  • Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination [ Time Frame: One month after second, third vaccination ] [ Designated as safety issue: No ]
  • hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination [ Time Frame: Before vaccination (Vac) 1, 1 Month after Vac 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination [ Time Frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination [ Time Frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 ] [ Designated as safety issue: No ]
    Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.

  • Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination [ Time Frame: One month after third bivalent rLP2086 vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination [ Time Frame: One month after third bivalent rLP2086 vaccination (Vac) ] [ Designated as safety issue: No ]

Enrollment: 3596
Study Start Date: April 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086 lot 1 Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
Experimental: rLP2086 lot 2 Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 2)
Experimental: rLP2086 lot 3 Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Active Comparator: Control
Havrix (HAV) and Saline
Biological: Havrix (HAV)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
Biological: Saline
0.5 mL dose of sterile normal saline for injection.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subject aged >=10 and <19 years at the time of enrollment.
  2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

  1. Previous vaccination with any meningococcal serogroup B vaccine.
  2. Subjects who have received prior HAV vaccination.
  3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
  4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  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.
  6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  7. Current chronic use of systemic antibiotics.
  8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
  9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  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: NCT01830855

  Show 99 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01830855     History of Changes
Other Study ID Numbers: B1971009  6108A1-3001  2010-023873-20 
Study First Received: April 3, 2013
Results First Received: October 14, 2015
Last Updated: May 5, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2016