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Completed

NCT Number: NCT01830855

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 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.

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Key information

Conditions

Meningococcal Vaccine

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medicor Research Inc., Greater Sudbury, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Subjects who have received prior HAV vaccination.
  • 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.
  • Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • 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.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Current chronic use of systemic antibiotics.
  • Received any investigational vaccines, drugs, 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.

Treatment and study plan

rLP2086

Biological

0.5 mL dose, given at 0, 2 and 6 months (lot 1)

Havrix (HAV)

Biological

0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.

Saline

Biological

0.5 mL dose of sterile normal saline for injection.

Primary outcomes

  1. 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

    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.

  2. 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

  3. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination

    Time frame: Within 7 Days after first vaccination

  4. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination

    Time frame: Within 7 Days after second vaccination

  5. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination

    Time frame: Within 7 Days after third vaccination

  6. Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination

    Time frame: Within 7 Days after first vaccination

    Here, N signifies participants with known values reporting specific characteristic.

  7. Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination

    Time frame: Within 7 Days after second vaccination

    Here, N signifies participants with known values reporting specific characteristic.

  8. Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination

    Time frame: Within 7 Days after third vaccination

    Here, N signifies participants with known values reporting specific characteristic.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination

    Time frame: Within 30 days after first vaccination

  17. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination

    Time frame: Within 30 days after second vaccination

  18. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination

    Time frame: Within 30 days after third vaccination

  19. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination

    Time frame: Within 30 days after any vaccination

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination

    Time frame: Within 30 days after first vaccination

  31. Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination

    Time frame: Within 30 days after second vaccination

  32. Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination

    Time frame: Within 30 days after third vaccination

  33. Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination

    Time frame: Within 30 Days after any vaccination

  34. 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

  35. Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination

    Time frame: Within 30 minutes after first vaccination

  36. Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination

    Time frame: Within 30 minutes after second vaccination

  37. Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination

    Time frame: Within 30 minutes after third vaccination

  38. 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

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

  7. 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

  8. 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

  9. 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

    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.

  10. 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

  11. 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)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2013
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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