Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Meningococcal Disease Clinical Trial

Official title:

A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285777
• Other study ID #: 205232
• Secondary ID: V102_16E1
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2014
• Est. completion date: June 11, 2015

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be invited at the time of their last study visit to participate in this extension study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 11, 2015
• Est. primary completion date: March 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).

Exclusion Criteria:

• Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.

• History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Meningococcal ABCWY
One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
• Placebo
One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Newton	Kansas
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.	At Month 7 (1 month after the 3-dose vaccination series)
Secondary	Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.	At Month 10 (4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.	The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series	The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).	At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With Enc-hSBA = 1:4 and Enc-hSBA =1:8 at 1 and 4 Months After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA = 1:4 and enc-hSBA = 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains = Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers = LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.	At Month 7 (1 month after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains = LLQ at 4 Months After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers = LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.; The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.	At Month 10 (4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With a Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.	At months 7 and 10 (1 and 4 months after 3-dose vaccination series)
Secondary	Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.	The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y = LLQ at 1 Month After the 3- Dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2, 39.6 and 14.7 respectively.	At Month 7 (1 month after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y = LLQ at 4 Months After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series. The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.	At Month 10 (4 months after the 3-dose vaccination series)
Secondary	Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers = 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers = LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.	At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains= 5, = 8, = 16, = 32, = 64, = 128 at 1 Month After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers = 5, = 8, = 16, = 32, = 64, = 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.	At Month 7 (1 month after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains = 5, = 8, = 16, = 32, = 64, = 128 at 4 Months After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers = 5, = 8, = 16, = 32, = 64, = 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.	At Month 10 (4 months after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y = 8, = 16, = 32, = 64, =128 at 1 Month After the 3- Dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers = 8, = 16, = 32, = 64, =128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.	At Month 7 (1 month after the 3-dose vaccination series)
Secondary	Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y =8, = 16, = 32, = 64, =128 at 4 Months After the 3-dose Vaccination Series	The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers= 8, = 16, = 32, = 64, = 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.	At Month 10 (4 months after the 3-dose vaccination series)
Secondary	Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)	Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.	Day 1 (6 hours) to Day 7 after vaccination
Secondary	Number of Subjects Reporting Any Unsolicited AEs	The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	Day 1 to Day 30 after any vaccination
Secondary	Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.	The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.	During the entire study period (from Day 0 up to Month 10)