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A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

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ClinicalTrials.gov Identifier: NCT04645966
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine Biological: MenABCWY Biological: Bivalent rLP2086 (60-µg Dose) Biological: Bivalent rLP2086 (120-µg Dose) Biological: Bexsero Drug: Prophylactic Liquid Paracetamol (PLP) Biological: Nimenrix Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
Actual Study Start Date : November 26, 2020
Estimated Primary Completion Date : April 4, 2023
Estimated Study Completion Date : April 4, 2023


Arm Intervention/treatment
Experimental: MenABCWY with PLP - 6 months of age
Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations.
Biological: MenABCWY
Neisseria mengitidis groups A, B, C W, and Y vaccine

Drug: Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2

Experimental: MenABCWY - 6 months of age
Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule
Biological: MenABCWY
Neisseria mengitidis groups A, B, C W, and Y vaccine

Experimental: Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP - 2 months of age
Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP during primary vaccinations
Biological: Bivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine

Drug: Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age
Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule
Biological: Bivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age
Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations.
Biological: Bivalent rLP2086 (120-µg Dose)
Trumenba - Meningococcal Group B vaccine

Drug: Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: Bivalent rLP2086 (120-µg Dose) and Nimenrix - 2 months of age
Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule
Biological: Bivalent rLP2086 (120-µg Dose)
Trumenba - Meningococcal Group B vaccine

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: MenABCWY with PLP - 2 months of age
Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given PLP during primary vaccinations.
Biological: MenABCWY
Neisseria mengitidis groups A, B, C W, and Y vaccine

Drug: Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2

Experimental: MenABCWY - 2 months of age
Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule
Biological: MenABCWY
Neisseria mengitidis groups A, B, C W, and Y vaccine

Experimental: Bexsero and Nimenrix with PLP - 2 months of age
Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations
Biological: Bexsero
Bexsero - Meningococcal Group B vaccine

Drug: Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: Bexsero and Nimenrix - 2 months of age
Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule
Biological: Bexsero
Bexsero - Meningococcal Group B vaccine

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine

Experimental: MenABCWY with / without PLP - 2 months of age
Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with a determined ratio of participants given or not given PLP during primary vaccinations.
Biological: MenABCWY
Neisseria mengitidis groups A, B, C W, and Y vaccine

Experimental: Bexsero and Nimenrix with / without PLP - 2 months of age
Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, with a determined ratio of participants given or not given PLP during primary vaccinations
Biological: Bexsero
Bexsero - Meningococcal Group B vaccine

Biological: Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine




Primary Outcome Measures :
  1. The percentage of participants achieving an hSBA titer ≥ LLOQ (Lower Limit of Quantitation) for each MenA, MenC, MenW, and MenY test strain - Groups 7, 9 and 11 combined versus Groups 8, 10 and 12 combined [ Time Frame: 1 month after primary vaccination 2 ]
    To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after 2 primary vaccinations.

  2. The percentage of participants achieving an hSBA titer ≥ LLOQ for each MenA, MenC, MenW, and MenY test strain - Groups 7, 9 and 11 combined versus Groups 8, 10 and 12 combined [ Time Frame: 1 month after the booster vaccination ]
    To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after a booster dose.

  3. The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 7, 9 and 11 combined versus Groups 8, 10 and 12 combined [ Time Frame: 1 month after primary vaccination 2 ]
    To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after 2 primary vaccinations.

  4. The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 7, 9 and 11 combined versus Groups 8, 10 and 12 combined [ Time Frame: 1 month after the booster vaccination ]
    To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after a booster dose.

  5. The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 3 and 4 combined and Groups 5 and 6 combined [ Time Frame: 1 month after primary vaccination 2 ]
    To describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after 2 primary vaccinations.

  6. The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 3 and 4 combined and Groups 5 and 6 combined [ Time Frame: 1 month after the booster vaccination ]
    To describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after a booster dose.

  7. The percentage of participants reporting local reactions after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: With 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP, and after a booster dose.

  8. The percentage of participants reporting systemic events after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: With 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP, and after a booster dose.

  9. The percentage of participants reporting use of antipyretic medication after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: With 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP, and after a booster dose.

  10. The percentage of participants reporting at least 1 SAE (Serious Adverse Event) within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  11. The percentage of participants reporting at least 1 SAE (Serious Adverse Event) within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  12. The percentage of participants reporting at least 1 SAE from study entry through 1 month after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  13. The percentage of participants reporting at least 1 SAE from 1 month through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  14. The percentage of participants reporting at least 1 SAE from study entry through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  15. The percentage of participants reporting at least 1 MAE (Medically Attended Adverse Event) within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  16. The percentage of participants reporting at least 1 MAE (Medically Attended Adverse Event) within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  17. The percentage of participants reporting at least 1 MAE from study entry through 1 month after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  18. The percentage of participants reporting at least 1 MAE from 1 month through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  19. The percentage of participants reporting at least 1 MAE from study entry through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccination - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  20. The percentage of participants reporting at least 1 NDCMC (Newly Diagnosed Chronic Medical Condition) within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  21. The percentage of participants reporting at least 1 NDCMC (Newly Diagnosed Chronic Medical Condition) within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  22. The percentage of participants reporting at least 1 NDCMC from study entry through 1 month after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  23. The percentage of participants reporting at least 1 NDCMC from 1 month through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  24. The percentage of participants reporting at least 1 NDCMC from study entry through 8 months after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  25. The percentage of participants reporting at least 1 Adverse Event (AE) within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  26. The percentage of participants reporting at least 1 AE within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  27. The percentage of participants reporting at least 1 AE from study entry through 1 month after primary vaccination 2, with, without, and irrespective of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  28. The percentage of participants reporting at least 1 immediate AE within 30 minutes after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: Within 30 minutes after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of MenABCWY after primary vaccinations with and without PLP.

  29. The percentage of participants reporting at least 1 SAE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  30. The percentage of participants reporting at least 1 SAE during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt after primary vaccinations.

  31. The percentage of participants reporting at least 1 SAE throughout the booster stage, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  32. The percentage of participants reporting at least 1 MAE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  33. The percentage of participants reporting at least 1 MAE during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  34. The percentage of participants reporting at least 1 MAE throughout the booster stage, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  35. The percentage of participants reporting at least 1 NDCMC during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  36. The percentage of participants reporting at least 1 NDCMC during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  37. The percentage of participants reporting at least 1 NDCMC throughout the booster stage, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.

  38. The percentage of participants reporting at least 1 AE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Groups 7, 9 and 11 versus Groups 8, 10 and 12 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of MenABCWY after a booster dose, regardless of PLP receipt during primary vaccinations.


Secondary Outcome Measures :
  1. hSBA GMTs (Geometric Mean Titer) for each of the MenB test strains - Groups 3 and 4 combined and Groups 5 and 6 combined [ Time Frame: 1 month after primary vaccination 2 ]
    To further describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after 2 primary vaccinations.

  2. hSBA GMTs for each of the MenB test strains - Groups 3 and 4 combined and Groups 5 and 6 combined [ Time Frame: 1 month after the booster vaccination ]
    To further describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after the booster vaccination.

  3. The percentage of participants reporting local reactions after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  4. The percentage of participants reporting systemic events after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  5. The percentage of participants reporting use of antipyretics medication after each primary vaccination with, without, and irrespective of PLP receipt, and after the booster vaccination - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 7 days after each primary vaccination and after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  6. The percentage of participants reporting at least 1 SAE within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  7. The percentage of participants reporting at least 1 SAE within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  8. The percentage of participants reporting at least 1 SAE during the primary series vaccination phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  9. The percentage of participants reporting at least 1 SAE during the primary series follow-up phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  10. The percentage of participants reporting at least 1 SAE throughout the primary series stage, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  11. The percentage of participants reporting at least 1 MAE within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  12. The percentage of participants reporting at least 1 MAE within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  13. The percentage of participants reporting at least 1 MAE during the primary series vaccination phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  14. The percentage of participants reporting at least 1 MAE during the primary series follow-up phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  15. The percentage of participants reporting at least 1 MAE throughout the primary series stage, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  16. The percentage of participants reporting at least 1 NDCMC within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  17. The percentage of participants reporting at least 1 NDCMC within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  18. The percentage of participants reporting at least 1 NDCMC during the primary series vaccination phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  19. The percentage of participants reporting at least 1 NDCMC during the primary series vaccination phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  20. The percentage of participants reporting at least 1 NDCMC throughout the primary series stage, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 8 months after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  21. The percentage of participants reporting at least 1 AE within 30 days after each primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after each primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  22. The percentage of participants reporting at least 1 AE within 30 days after any primary vaccination with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 days after any primary vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  23. The percentage of participants reporting at least 1 AE during the primary series vaccination phase, with, without, and irrespective of PLP receipt - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From study entry through 1 month after primary vaccination 2 ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  24. The percentage of participants reporting at least 1 immediate AE after each primary vaccination with, without and irrespective of PLP receipt, and after the booster vaccination - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: Within 30 minutes of each primary vaccination and after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  25. The percentage of participants reporting at least 1 SAE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  26. The percentage of participants reporting at least 1 SAE during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  27. The percentage of participants reporting at least 1 SAE throughout the booster stage, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  28. The percentage of participants reporting at least 1 MAE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  29. The percentage of participants reporting at least 1 MAE during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  30. The percentage of participants reporting at least 1 MAE throughout the booster stage, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  31. The percentage of participants reporting at least 1 NDCMC during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  32. The percentage of participants reporting at least 1 NDCMC during the booster follow-up phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From 1 month through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  33. The percentage of participants reporting at least 1 NDCMC throughout the booster stage, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 6 months after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.

  34. The percentage of participants reporting at least 1 AE during the booster vaccination phase, regardless of PLP receipt during primary vaccinations - Group 3, Group 4, Group 5 and Group 6 [ Time Frame: From the booster vaccination through 1 month after the booster vaccination ]
    To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without PLP, and after a booster dose.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization.
  2. Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.
  4. Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
  5. Body weight ≥4 kg for participants 2 months of age at the time of randomization.
  6. Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

  1. Prior adverse reaction to paracetamol use, including allergic reactions.
  2. Participant was born prematurely (<37 weeks of gestation).
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  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 participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the SRM for additional details.
  6. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
  7. Significant neurological disorder or history of seizure (including simple febrile seizure).
  8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  9. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  10. Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
  11. For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine.
  12. Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  13. Receipt of any blood products, including immunoglobulin, before the first study vaccination.
  14. Current chronic use of systemic antibiotics.
  15. Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645966


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04645966    
Other Study ID Numbers: C3511002
2020-000948-60 ( EudraCT Number )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Meningococcal Vaccine
Invasive Meningococcal Disease
Meningococcal Serogroups A, B, C W and Y
MenABCWY Vaccine
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics