A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 10 to 50 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

Trial locations and contacts

53 sites in 8 countries.

About this study

Official title: A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)

Conditions

Infections, Meningococcal

Being tested

MenABCWY-2Gen low dose vaccine, MenABCWY-2Gen high dose vaccine, Placebo, MenB vaccine, MenACWY vaccine

Keywords

Bexsero, Menveo, Boostrix, MenABCWY-2Gen, Effectiveness, Safety, Invasive Meningococcal Disease, Adolescents and Adults

Medical subject headings

Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• MenABCWY-2Gen low dose vaccineCombination product

  MenABCWY-2Gen low dose vaccine is administered intramuscularly as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose_06 Group and ABCWY low dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose_01 Group, ABCWY low doseS_02 Group and ABCWY low doseS_06 Group in study Phase II (Sourcing).

• MenABCWY-2Gen high dose vaccineCombination product

  MenABCWY-2Gen high dose vaccine is administered intramuscularly 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose_06 Group and ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose_01 Group, ABCWY high doseS_02 Group and ABCWY high doseS_06 Group in study Phase II (Sourcing).

• PlaceboCombination product

  Also called NaCl, saline solution

  Placebo is administered intramuscularly as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose_06 Group, ABCWY low dose_02 Group, ABCWY high dose_06 Group, ABCWY high dose_02 Group in study Phase II (Formulation and Schedule-finding).

• MenB vaccineCombination product

  Also called GSK's meningococcal group B vaccine, Bexsero

  MenB vaccine is administered intramuscularly as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

• MenACWY vaccineBiological

  Also called GSK's combined meningococcal groups A, C, Y and W-135 conjugate vaccine, Menveo

  MenACWY vaccine is administered intramuscularly as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)

   The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.

   Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

2. Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)

   The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.

   Measured: During the 7 days (including the day of vaccination) following vaccination at Day 31

3. Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)

   The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.

   Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

4. Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)

   The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.

   Measured: During the 7 days (including the day of vaccination) following vaccination at Day 31

5. Number of Participants With Any Unsolicited Adverse Events (AEs), Including All Serious Adverse Events (SAEs), AEs Leading to Withdrawal and AEs of Special Interest (AESIs) in Study Phase I (Safety Lead-in)

   Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

   Measured: During the 30 days (including the day of vaccination) following vaccination at Day 1

6. Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)

   Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

   Measured: During the 30 days (including the day of vaccination) following vaccination at Day 31

7. Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)

   A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

   Measured: Throughout the Phase 1 study period (Day 1 through Day 211)

8. Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)

   The safety laboratory data included haematological parameters (basophils, eosinophils, Erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine) Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

   Measured: At Day 8 (7 days after the first vaccination)

9. Number of Participants With Clinically Significant Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)

   Clinical laboratory testing included hematological and biochemical laboratory values. Any abnormal laboratory test result (e.g., in hematology or clinical chemistry) that was deemed clinically significant by the investigator's medical and scientific judgment, and not related to an underlying disease, was reported as an unsolicited adverse event (AE) unless it was considered by the investigator to be more severe than expected for the participant's condition. The safety laboratory data included hematological parameters (basophils, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets, and neutrophils) and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], and creatinine).

   Measured: At Day 8 (7 days after the first vaccination)

10. Percentage of Blood Samples With Bactericidal Serum Activity Using Enc-hSBA Against a Panel of 110 Randomly Selected Endemic US N. Meningitidis Serogroup B Invasive Disease Strains at Study Phase II (Formulation and Schedule-finding)

    The effectiveness of the MenABCWY-2Gen (low \& high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenB vaccine administered at 0,6-months schedule, against a panel of 110 randomly selected endemic N. meningitidis serogroup B strains is measured in terms of percentage of samples with bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

    Measured: At Day 211 (1 month after the last vaccination)

11. Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)

    The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenACWY vaccine (single dose), relative to day 1 in the ABCWY and control groups (0, 6 month schedule) and day 31 in ABCWY (0, 2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titer < 4, -a post-vaccination hSBA titer ≥ 4 times the lower limit of quantitation (LLOQ) for participants with a pre-vaccination hSBA titer ≥LOD but <LLOQ, and. -a post-vaccination hSBA titer ≥ 4 times the pre-vaccination hSBA titer for participants with a pre-vaccination hSBA titer ≥LLOQ.

    Measured: At Day 211 for ABCWY groups (1 month after the last MenABCWY-2Gen vaccination) and at Day 31 for Control group (1 month after the last MenACWY vaccination)

12. Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

13. Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 121

14. Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 181

15. Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

16. Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 121

17. Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 181

18. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 1

19. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 121

20. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 181

21. Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Formulation and Schedule-Finding)

    A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: Throughout the Phase II FSF study period (Day 1 through Day 541)

22. Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

23. Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 31

24. Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 61

25. Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)

    Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 181

26. Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1

27. Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 31

28. Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 61

29. Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)

    Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

    Measured: During the 7 days (including the day of vaccination) following vaccination at Day 181

30. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 1

31. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 31

32. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 61

33. Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)

    Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: During the 30 days (including the day of vaccination) following vaccination at Day 181

34. Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)

    A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: Throughout the study period (Day 1 through Day 211)

35. Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)

    A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: Throughout the study period (Day 1 through Day 241)

36. Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)

    A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.

    Measured: Throughout the study period (Day 1 through Day 361)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 May 2021
2. Study start14 Jun 2021
3. Primary completion2 Feb 2024
4. Study completion2 Feb 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
• More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.