Trial Outcomes & Findings for Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune® (NCT NCT00269477)

Last Updated: 2016-04-14

Results Overview

Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)

Results posted on

2016-04-14

Participant Flow

Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.

A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.

Participant milestones

Participant milestones
Measure	Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Overall Study STARTED	9	18	58	60
Overall Study COMPLETED	4	12	57	60
Overall Study NOT COMPLETED	5	6	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Overall Study Protocol Violation	5	5	1	0
Overall Study Missed post-vaccination blood draw	0	1	0	0

Baseline Characteristics

Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menactra® Vaccine Group 1 n=9 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 n=18 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 n=58 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 n=60 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Total n=145 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	10 Participants n=7 Participants	53 Participants n=5 Participants	54 Participants n=4 Participants	122 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	18.1 years STANDARD_DEVIATION 1.62 • n=5 Participants	18.8 years STANDARD_DEVIATION 1.86 • n=7 Participants	16.4 years STANDARD_DEVIATION 1.38 • n=5 Participants	16.6 years STANDARD_DEVIATION 1.81 • n=4 Participants	17.9 years STANDARD_DEVIATION 2.24 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants	28 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	31 Participants n=5 Participants	32 Participants n=4 Participants	72 Participants n=21 Participants
Region of Enrollment United States	9 participants n=5 Participants	18 participants n=7 Participants	58 participants n=5 Participants	60 participants n=4 Participants	145 participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)

Population: SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine Group 1 n=4 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 n=12 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 n=57 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 n=60 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup A - Day 0	4 Participants	12 Participants	25 Participants	25 Participants
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup A - Day 28	4 Participants Interval 1677.5 to 320034.7	12 Participants Interval 14221.4 to 47563.3	56 Participants Interval 15101.3 to 29164.0	60 Participants Interval 12672.1 to 26079.6
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup C - Day 0	2 Participants	8 Participants	15 Participants	20 Participants
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup C - Day 28	4 Participants Interval 2803.6 to 191496.7	12 Participants Interval 8654.7 to 62032.2	56 Participants Interval 4405.0 to 11319.3	60 Participants Interval 3472.0 to 8413.3
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup Y - Day 0	3 Participants	12 Participants	49 Participants	52 Participants
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup Y - Day 28	4 Participants Interval 161.4 to 294032.5	12 Participants Interval 5353.8 to 31586.0	57 Participants Interval 3453.0 to 7346.6	60 Participants Interval 2833.2 to 5921.5
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup W-135 - Day 0	3 Participants	12 Participants	25 Participants	28 Participants
Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. Meningococcal serogroup W-135 - Day 28	4 Participants Interval 5578.8 to 96234.1	12 Participants Interval 7461.5 to 50878.1	57 Participants Interval 6158.1 to 14240.4	60 Participants Interval 5178.0 to 10773.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to 7 post-vaccination

Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population

Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine Group 1 n=9 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 n=18 Participants Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 n=58 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 n=60 Participants Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Erythema	2 Participants	2 Participants	13 Participants	14 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Erythema (≥ 2 inches)	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Swelling	1 Participants	0 Participants	12 Participants	3 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Swelling (≥ 2 inches)	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Injection Site Pain	2 Participants	8 Participants	36 Participants	37 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Injection Site Pain (Incapacitating)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Fever	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Fever (≥ 39.6 ºC)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Headache	0 Participants	5 Participants	20 Participants	28 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Headache (Prevents daily activities)	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Malaise	1 Participants	3 Participants	15 Participants	22 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Malaise (Prevents daily activities)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Any Myalgia	2 Participants	6 Participants	24 Participants	28 Participants
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Grade 3 Myalgia (Prevents daily activities)	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Menactra® Vaccine Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Menactra® Vaccine Group 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Meningococcal Vaccine-naive Group 3

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Meningococcal Vaccine-naive Group 4

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Menactra® Vaccine Group 1 n=9 participants at risk Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.	Menactra® Vaccine Group 2 n=18 participants at risk Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.	Meningococcal Vaccine-naive Group 3 n=58 participants at risk Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination	Meningococcal Vaccine-naive Group 4 n=60 participants at risk Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	3.4% 2/58 • Number of events 2 • 28 days post-booster or post-primary Menactra® vaccination	6.7% 4/60 • Number of events 5 • 28 days post-booster or post-primary Menactra® vaccination
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	5.2% 3/58 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination	6.7% 4/60 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination
Gastrointestinal disorders Nausea	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/58 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination
Gastrointestinal disorders Vomiting	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	3.4% 2/58 • Number of events 2 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination
General disorders Injection site haemorrhage	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	1.7% 1/58 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination
General disorders Injection site induration	11.1% 1/9 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/58 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/60 • 28 days post-booster or post-primary Menactra® vaccination
General disorders Venipuncture site bruise	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	5.6% 1/18 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/58 • 28 days post-booster or post-primary Menactra® vaccination	1.7% 1/60 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination
Infections and infestations Nasopharyngitis	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	6.9% 4/58 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination
Infections and infestations Pharyngitis	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	5.2% 3/58 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination	1.7% 1/60 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination
Infections and infestations Rhinitis	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	5.2% 3/58 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/60 • 28 days post-booster or post-primary Menactra® vaccination
Infections and infestations Upper respiratory tract infection	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	5.6% 1/18 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	10.3% 6/58 • Number of events 6 • 28 days post-booster or post-primary Menactra® vaccination	1.7% 1/60 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination
Injury, poisoning and procedural complications Joint sprain	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	5.2% 3/58 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/60 • 28 days post-booster or post-primary Menactra® vaccination
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	15.5% 9/58 • Number of events 9 • 28 days post-booster or post-primary Menactra® vaccination	18.3% 11/60 • Number of events 18 • 28 days post-booster or post-primary Menactra® vaccination
Reproductive system and breast disorders Dysmenorrhoea	11.1% 1/9 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination	11.1% 2/18 • Number of events 2 • 28 days post-booster or post-primary Menactra® vaccination	3.4% 2/58 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination	6.7% 4/60 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	5.6% 1/18 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	3.4% 2/58 • Number of events 2 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 3 • 28 days post-booster or post-primary Menactra® vaccination
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/18 • 28 days post-booster or post-primary Menactra® vaccination	6.9% 4/58 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination	5.0% 3/60 • Number of events 4 • 28 days post-booster or post-primary Menactra® vaccination
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/9 • 28 days post-booster or post-primary Menactra® vaccination	5.6% 1/18 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	1.7% 1/58 • Number of events 1 • 28 days post-booster or post-primary Menactra® vaccination	0.00% 0/60 • 28 days post-booster or post-primary Menactra® vaccination