Trial Outcomes & Findings for A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea (NCT NCT01274897)

Last Updated: 2012-10-16

Results Overview

Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as: 1. for subjects with a pre-vaccination hSBA titer \< 1:4, a postvaccination hSBA titer ≥ 1:8. 2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

450 participants

Primary outcome timeframe

day 29

Results posted on

2012-10-16

Participant Flow

Participants were enrolled at 8 centres in the Korea.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo Subjects received the saline placebo.
Overall Study STARTED	297	153
Overall Study COMPLETED	297	153
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM n=297 Participants Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=153 Participants Subjects received the saline placebo.	Total n=450 Participants Total of all reporting groups
Age Continuous Age, Years	19.6 years STANDARD_DEVIATION 9.2 • n=93 Participants	19.3 years STANDARD_DEVIATION 8.9 • n=4 Participants	19.5 years STANDARD_DEVIATION 9.1 • n=27 Participants
Sex: Female, Male Female	139 Participants n=93 Participants	77 Participants n=4 Participants	216 Participants n=27 Participants
Sex: Female, Male Male	158 Participants n=93 Participants	76 Participants n=4 Participants	234 Participants n=27 Participants

PRIMARY outcome

Timeframe: day 29

Population: Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=296 Participants Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=152 Participants Subjects received the saline placebo.
Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup C (N=293,150)	86 Percentages of subjects Interval 82.0 to 90.0	1 Percentages of subjects Interval 0.0 to 5.0
Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup A (N=295,152)	76 Percentages of subjects Interval 71.0 to 81.0	1 Percentages of subjects Interval 0.0 to 5.0
Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup W (N=293,151)	28 Percentages of subjects Interval 23.0 to 33.0	4 Percentages of subjects Interval 1.0 to 8.0
Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup Y (N=294,152)	69 Percentages of subjects Interval 63.0 to 74.0	2 Percentages of subjects Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: day 1 and day 29

Population: Analysis was done on PP population.

Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=296 Participants Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=152 Participants Subjects received the saline placebo.
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup C at Day 29 (N=293,150)	231 Titers Interval 198.0 to 269.0	6.04 Titers Interval 4.89 to 7.47
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup A at Day 1 (N=295,152)	2.7 Titers Interval 2.47 to 2.95	2.86 Titers Interval 2.53 to 3.24
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup A at Day 29 (N=295,152)	48 Titers Interval 39.0 to 57.0	3 Titers Interval 2.31 to 3.88
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup C at Day 1 (N=293,150)	7.82 Titers Interval 6.76 to 9.05	5.94 Titers Interval 4.85 to 7.27
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup W at Day 1 (N=293,151)	51 Titers Interval 44.0 to 61.0	48 Titers Interval 38.0 to 60.0
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup W at Day 29 (N=293,151)	147 Titers Interval 125.0 to 171.0	47 Titers Interval 38.0 to 58.0
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup Y at Day 1 (N=294,152)	9.01 Titers Interval 7.64 to 11.0	8.82 Titers Interval 7.02 to 11.0
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup Y at Day 29 (N=294,152)	107 Titers Interval 89.0 to 128.0	8.4 Titers Interval 6.54 to 11.0

SECONDARY outcome

Timeframe: day 1 and day 29

Population: Analysis was done on PP population.

Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=296 Participants Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=152 Participants Subjects received the saline placebo.
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup C at Day 1 (N=293,150)	49 Percentages of subjects Interval 44.0 to 55.0	39 Percentages of subjects Interval 31.0 to 47.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup W at Day 1 (N=293,151)	89 Percentages of subjects Interval 85.0 to 92.0	87 Percentages of subjects Interval 80.0 to 92.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup A at Day 1 (N=295,152)	13 Percentages of subjects Interval 9.0 to 17.0	15 Percentages of subjects Interval 10.0 to 22.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup A at Day 29 (N=295,152)	79 Percentages of subjects Interval 74.0 to 84.0	16 Percentages of subjects Interval 10.0 to 23.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup C at Day 29 (N=293,150)	99 Percentages of subjects Interval 97.0 to 100.0	37 Percentages of subjects Interval 30.0 to 46.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup W at Day 29 (N=293,151)	98 Percentages of subjects Interval 96.0 to 99.0	88 Percentages of subjects Interval 82.0 to 93.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup Y at Day 1 (N=294,152)	54 Percentages of subjects Interval 48.0 to 60.0	53 Percentages of subjects Interval 44.0 to 61.0
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. Serogroup Y at Day 29 (N=294,152)	94 Percentages of subjects Interval 91.0 to 97.0	51 Percentages of subjects Interval 42.0 to 59.0

SECONDARY outcome

Timeframe: during 7 days of vaccination

Population: Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.

Outcome measures

Outcome measures
Measure	MenACWY-CRM n=297 Participants Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=153 Participants Subjects received the saline placebo.
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Headache	39 Subjects	25 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Rash	1 Subjects	0 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Used analgesic or antipyretic medicines	7 Subjects	3 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Injection site pain	69 Subjects	12 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Injection site erythema	30 Subjects	3 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Injection site induration	30 Subjects	0 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Chills	17 Subjects	7 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Nausea	22 Subjects	10 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Myalgia	45 Subjects	13 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Arthralgia	6 Subjects	4 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Fever (≥38°C)	3 Subjects	1 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Axillary temperature (<38.0°C)	294 Subjects	152 Subjects
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination Stayed home	9 Subjects	2 Subjects

Adverse Events

MenACWY-CRM

Serious events: 0 serious events

Other events: 117 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MenACWY-CRM n=297 participants at risk Subjects received one dose of MenACWY-CRM conjugate vaccine.	Placebo n=153 participants at risk Subjects received the saline placebo.
Gastrointestinal disorders Nausea	7.4% 22/297 • Number of events 22 • Throughout the study period (29 days)	6.5% 10/153 • Number of events 10 • Throughout the study period (29 days)
General disorders Chills	5.7% 17/297 • Number of events 17 • Throughout the study period (29 days)	4.6% 7/153 • Number of events 7 • Throughout the study period (29 days)
General disorders Injection site erythema	10.1% 30/297 • Number of events 30 • Throughout the study period (29 days)	2.0% 3/153 • Number of events 3 • Throughout the study period (29 days)
General disorders Injection site induration	10.1% 30/297 • Number of events 30 • Throughout the study period (29 days)	0.00% 0/153 • Throughout the study period (29 days)
General disorders Injection site pain	23.2% 69/297 • Number of events 69 • Throughout the study period (29 days)	7.8% 12/153 • Number of events 12 • Throughout the study period (29 days)
General disorders Malaise	7.1% 21/297 • Number of events 21 • Throughout the study period (29 days)	5.9% 9/153 • Number of events 9 • Throughout the study period (29 days)
Musculoskeletal and connective tissue disorders Myalgia	15.5% 46/297 • Number of events 46 • Throughout the study period (29 days)	8.5% 13/153 • Number of events 13 • Throughout the study period (29 days)
Nervous system disorders Headache	13.1% 39/297 • Number of events 39 • Throughout the study period (29 days)	16.3% 25/153 • Number of events 25 • Throughout the study period (29 days)

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60