Trial Outcomes & Findings for Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age (NCT NCT01659996)

Last Updated: 2015-12-15

Results Overview

Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC). Menactra vaccine response defined as subjects with an hSBA titer \<1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1394 participants

Primary outcome timeframe

Day 30 post second Menactra vaccination

Results posted on

2015-12-15

Participant Flow

Participants were enrolled from 24 July 2012 to 14 June 2013 in 62 clinical centers in the United States.

A total of 1394 participants were enrolled for the study, data on 1288 participants who met all the inclusion and none of the exclusion criteria and who completed the vaccination schedule are presented in this report.

Participant milestones

Participant milestones
Measure	Menactra Vaccine Group All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months	Menactra + Pentacel Vaccine Group All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group Study participants received only Pentacel vaccine at 15 to 18 months of age
Overall Study STARTED	421	395	472
Overall Study COMPLETED	413	388	461
Overall Study NOT COMPLETED	8	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Menactra Vaccine Group All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months	Menactra + Pentacel Vaccine Group All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group Study participants received only Pentacel vaccine at 15 to 18 months of age
Overall Study Protocol Violation	3	3	3
Overall Study Lost to Follow-up	1	3	2
Overall Study Adverse Event	0	0	1
Overall Study Withdrawal by Subject	4	1	5

Baseline Characteristics

Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menactra Vaccine Group n=421 Participants Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months	Menactra + Pentacel Vaccine Group n=395 Participants Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months	Pentacel Vaccine Group n=472 Participants Study participants received only Pentacel vaccine at 15 to 18 months of age	Total n=1288 Participants Total of all reporting groups
Age, Categorical <=18 years	421 Participants n=5 Participants	395 Participants n=7 Participants	472 Participants n=5 Participants	1288 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Age, Continuous	284.5 Days STANDARD_DEVIATION 10.8 • n=5 Participants	284.6 Days STANDARD_DEVIATION 10.6 • n=7 Participants	483.9 Days STANDARD_DEVIATION 30.3 • n=5 Participants	353.6 Days STANDARD_DEVIATION 96.8 • n=4 Participants
Sex: Female, Male Female	219 Participants n=5 Participants	171 Participants n=7 Participants	232 Participants n=5 Participants	622 Participants n=4 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	224 Participants n=7 Participants	240 Participants n=5 Participants	666 Participants n=4 Participants
Region of Enrollment United States	421 Participants n=5 Participants	395 Participants n=7 Participants	472 Participants n=5 Participants	1288 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 30 post second Menactra vaccination

Population: Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group n=352 Participants Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=333 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination Serogroup C (N=352, 333, 0)	98.86 Percentage of participants	97.60 Percentage of participants	—
Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination Serogroup A (N=346, 329, 0)	96.24 Percentage of participants	96.35 Percentage of participants	—
Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination Serogroup Y (N=351, 333, 0)	98.86 Percentage of participants	96.40 Percentage of participants	—
Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination Serogroup W-135 (N=351, 330, 0)	98.86 Percentage of participants	97.58 Percentage of participants	—

PRIMARY outcome

Timeframe: Day 30 post-vaccination 2

Population: Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.

Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=332 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=417 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Filamentous hemagglutinin FHA; N=0, 331, 417)	—	113.7 Titers Interval 105.0 to 123.0	110.1 Titers Interval 102.0 to 119.0
Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Pertussis Toxoid (PT; N=0, 332, 417)	—	73.5 Titers Interval 67.9 to 79.6	69.7 Titers Interval 64.9 to 75.0
Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Pertactin (PRN; N=0, 331, 417)	—	120.9 Titers Interval 107.0 to 137.0	133.9 Titers Interval 120.0 to 150.0

PRIMARY outcome

Timeframe: Day 30 post-vaccination 2

Population: Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.

Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is \<4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=330 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=417 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Pertussis Toxoid (PT; N=0, 330, 417)	—	90.91 Percentage of Participants	89.69 Percentage of Participants
Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Filamentous hemagglutinin (FHA; N=0,329, 417)	—	93.62 Percentage of Participants	94.48 Percentage of Participants
Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Pertactin (PRN; N=0, 329, 417)	—	93.62 Percentage of Participants	93.53 Percentage of Participants

PRIMARY outcome

Timeframe: Day 30 post-vaccination 2

Population: Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.

Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test. The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=336 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=418 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Diphtheria (N=0, 324, 416)	—	99.69 Percentage of Participants	100.00 Percentage of Participants
Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Tetanus (N=0, 326, 415)	—	100.00 Percentage of Participants	100.00 Percentage of Participants
Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polyribosylribitol phosphate (N=0, 324, 416)	—	97.53 Percentage of Participants	97.12 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccination 2

Population: Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.

Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group n=356 Participants Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=336 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group Study participants that received only Pentacel vaccine at 15 to 18 months of age
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup A (Pre-vaccination; N=352, 332, 0)	3.4 Titers Interval 3.16 to 3.74	4.3 Titers Interval 4.01 to 4.54	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup A (Post-vaccination; N=350, 332, 0)	104.8 Titers Interval 91.6 to 120.0	104.5 Titers Interval 90.9 to 120.0	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup C (Pre-vaccination; N=352, 332, 0)	2.2 Titers Interval 2.1 to 2.23	2.1 Titers Interval 2.03 to 2.16	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup C (Post-vaccination; N=350, 332, 0)	157.9 Titers Interval 139.0 to 179.0	129.1 Titers Interval 113.0 to 148.0	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup Y (Pre-vaccination; N=352, 332, 0)	2.1 Titers Interval 2.02 to 2.12	2.1 Titers Interval 2.03 to 2.17	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup Y (Post-vaccination; N=350, 332, 0)	77.8 Titers Interval 69.3 to 87.4	62.2 Titers Interval 54.7 to 70.7	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup W-135 (Pre-vaccination; N=352, 332, 0)	2.1 Titers Interval 2.05 to 2.13	2.1 Titers Interval 2.01 to 2.13	—
Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine Serogroup W-135 (Post-vaccination; N=350, 332, 0)	90.3 Titers Interval 78.9 to 103.0	81.1 Titers Interval 70.9 to 92.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 post-vaccination 2

Population: Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.

Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=336 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=418 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-FIM (pre-vaccination; N=0, 335, 418)	—	17.6 Titers Interval 15.5 to 19.8	23.2 Titers Interval 20.8 to 25.9
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-FIM (post-vaccination; N=0, 332, 417)	—	220.8 Titers Interval 191.0 to 255.0	265.5 Titers Interval 233.0 to 302.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-PRN (pre-vaccination; N=0, 334, 418)	—	10.3 Titers Interval 9.18 to 11.6	11.1 Titers Interval 9.95 to 12.3
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-PRN (post-vaccination; N=0, 331, 417)	—	120.9 Titers Interval 107.0 to 137.0	133.9 Titers Interval 120.0 to 150.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Diphtheria (pre-vaccination; N=0, 328, 418)	—	0.3 Titers Interval 0.235 to 0.306	0.2 Titers Interval 0.179 to 0.225
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Diphtheria (post-vaccination; N=0, 324, 416)	—	3.3 Titers Interval 3.0 to 3.68	4.2 Titers Interval 3.85 to 4.54
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Tetanus (pre-vaccination; N=0, 329, 414)	—	0.2 Titers Interval 0.2 to 0.268	0.2 Titers Interval 0.2 to 0.267
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Tetanus (post-vaccination; N=0, 326, 415)	—	3.7 Titers Interval 3.38 to 3.99	3.9 Titers Interval 3.56 to 4.18
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 1 (pre-vaccination; N=0, 326, 415)	—	83.1 Titers Interval 70.4 to 98.0	76.9 Titers Interval 64.7 to 91.2
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 1 (post-vaccination; N=0, 323, 414)	—	2140 Titers Interval 1819.0 to 2518.0	1887 Titers Interval 1653.0 to 2153.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 2 (pre-vaccination; N=0, 328, 417)	—	157.0 Titers Interval 136.0 to 181.0	182.8 Titers Interval 157.0 to 212.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 2 (post-vaccination; N=0, 324, 414)	—	3172 Titers Interval 2800.0 to 3593.0	3071 Titers Interval 2754.0 to 3425.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 3 (pre-vaccination; N=0, 327, 417)	—	107.1 Titers Interval 90.7 to 127.0	130.2 Titers Interval 110.0 to 155.0
Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Anti-Polio 3 (post-vaccination; N=0, 323, 415)	—	4629 Titers Interval 3980.0 to 5384.0	3765 Titers Interval 3305.0 to 4288.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 7 after any vaccination

Population: Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).

Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group n=421 Participants Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=395 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=472 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any injection-site Tenderness (N = 420, 393, 463)	52.1 Percentage of participants	61.6 Percentage of participants	51.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 inj.-siteTenderness (N = 420, 393, 463)	1.0 Percentage of participants	4.3 Percentage of participants	1.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any injection-site Erythema (N = 420, 393, 463)	25.2 Percentage of participants	38.7 Percentage of participants	31.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 inj.-site Erythema (N = 420, 393, 463)	0.2 Percentage of participants	0.8 Percentage of participants	1.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any injection-site Swelling (N = 420, 393, 463)	15.0 Percentage of participants	23.2 Percentage of participants	21.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 inj.-site Swelling (N = 420, 393, 463)	0.0 Percentage of participants	0.3 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any Fever (N = 421, 394, 463)	16.9 Percentage of participants	21.6 Percentage of participants	12.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Fever (N = 421, 394, 463)	1.4 Percentage of participants	2.8 Percentage of participants	0.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any Vomiting (N = 420, 393, 463)	22.6 Percentage of participants	17.3 Percentage of participants	9.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Vomiting (N = 420, 393, 463)	0.5 Percentage of participants	0.3 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any Crying abnormal (N = 420, 393, 463)	52.9 Percentage of participants	52.2 Percentage of participants	39.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Crying abnormal (N = 420, 393, 463)	4.0 Percentage of participants	5.1 Percentage of participants	2.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any Drowsiness (N = 420, 393, 463)	49.8 Percentage of participants	52.4 Percentage of participants	30.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Drowsiness (N = 421, 394, 463)	3.1 Percentage of participants	2.0 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Appetite lost (N = 420, 393, 463)	43.3 Percentage of participants	47.8 Percentage of participants	35.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Appetite lost (N = 420, 393, 463)	2.1 Percentage of participants	3.3 Percentage of participants	1.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Any Irritability (N = 420, 393, 463)	70.5 Percentage of participants	72.3 Percentage of participants	58.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine Grade 3 Irritability (N = 420, 393, 463)	6.4 Percentage of participants	6.9 Percentage of participants	2.4 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 7 after 9-month vaccination

Population: Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group n=421 Participants Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=395 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any injection-site Tenderness (N = 419, 387, 0)	32.2 Percentage of participants	34.1 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 injection-site Tenderness (N=419, 387, 0)	0.2 Percentage of participants	0.8 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any injection-site Erythema (N = 419, 387, 0)	16.9 Percentage of participants	24.3 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 injection-site Erythema (N = 419, 387, 0)	0.0 Percentage of participants	0.0 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any injection-site Swelling (N = 419, 385, 0)	10.0 Percentage of participants	9.4 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 injection-site Swelling (N = 419, 385, 0)	0.0 Percentage of participants	0.0 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any Fever (N = 421, 389, 0)	10.5 Percentage of participants	10.3 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Fever (N = 421, 389, 0)	0.7 Percentage of participants	1.5 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any Vomiting (N = 419, 387, 0)	15.5 Percentage of participants	12.9 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Vomiting (N = 419, 387, 0)	0.5 Percentage of participants	0.0 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any Crying abnormal (N = 419, 387, 0)	38.9 Percentage of participants	37.5 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Crying abnormal (N = 419, 387, 0)	3.3 Percentage of participants	2.8 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any Drowsiness (N = 419, 387, 0)	37.2 Percentage of participants	37.0 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Drowsiness (N = 419, 387, 0)	2.1 Percentage of participants	0.8 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Appetite lost (N = 419, 387, 0)	25.3 Percentage of participants	28.7 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Appetite lost (N = 419, 387, 0)	1.4 Percentage of participants	1.8 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Any Irritability (N = 419, 387, 0)	56.1 Percentage of participants	54.8 Percentage of participants	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine. Grade 3 Irritability (N = 419, 387, 0)	4.8 Percentage of participants	3.1 Percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 7 after the 15 to 18 month vaccination

Population: Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever \> 39.5°C or \> 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Group n=421 Participants Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.	Menactra + Pentacel Vaccine Group n=395 Participants Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.	Pentacel Vaccine Group n=472 Participants Study participants that received only Pentacel vaccine at 15 to 18 months of age
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any injection-site Tenderness (N = 411, 382, 463)	37.0 Percentage of participants	54.7 Percentage of participants	51.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 inj.-site Tenderness (N = 411, 382, 463)	0.7 Percentage of participants	3.7 Percentage of participants	1.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any injection-site Erythema (N = 411, 382, 463)	17.8 Percentage of participants	30.1 Percentage of participants	31.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 injection-site Erythema (N=411, 382, 463)	0.2 Percentage of participants	0.8 Percentage of participants	1.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any injection-site Swelling (N = 411, 382, 463)	9.2 Percentage of participants	19.6 Percentage of participants	21.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 injection-site Swelling (N=411, 382, 463)	0.0 Percentage of participants	0.3 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any Fever (N = 412, 385, 463)	8.5 Percentage of participants	14.3 Percentage of participants	12.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Fever (N = 412, 385, 463)	0.7 Percentage of participants	1.3 Percentage of participants	0.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any Vomiting (N = 411, 382, 463)	10.0 Percentage of participants	7.9 Percentage of participants	9.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Vomiting (N = 411, 382, 463)	0.0 Percentage of participants	0.3 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any Crying abnormal (N = 411, 382, 463)	33.8 Percentage of participants	37.2 Percentage of participants	39.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Crying abnormal (N = 411, 382, 463)	1.0 Percentage of participants	2.6 Percentage of participants	2.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any Drowsiness (N = 411, 382, 463)	30.9 Percentage of participants	40.6 Percentage of participants	30.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Drowsiness (N = 411, 382, 463)	1.0 Percentage of participants	1.3 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Appetite lost (N = 411, 382, 463)	29.7 Percentage of participants	34.0 Percentage of participants	35.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Appetite lost (N = 411, 382, 463)	0.7 Percentage of participants	1.6 Percentage of participants	1.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Any Irritability (N = 411, 382, 463)	50.6 Percentage of participants	57.9 Percentage of participants	58.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine Grade 3 Irritability (N = 411, 382, 463)	2.7 Percentage of participants	3.9 Percentage of participants	2.4 Percentage of participants

Adverse Events

Menactra Vaccine Group

Serious events: 13 serious events

Other events: 296 other events

Deaths: 0 deaths

Menactra + Pentacel Vaccine Group

Serious events: 11 serious events

Other events: 318 other events

Deaths: 0 deaths

Pentacel Vaccine Group

Serious events: 1 serious events

Other events: 380 other events

Deaths: 0 deaths

Serious adverse events

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 n=421 participants at risk Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months	Menactra + Pentacel Vaccine Group n=395 participants at risk Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months	Pentacel Vaccine Group n=472 participants at risk Study participants received only Pentacel vaccine at 15 to 18 months of age
Infections and infestations Subcutaneous abscess	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.25% 1/395 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Upper respiratory tract infection	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Viral infection	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.25% 1/395 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Injury, poisoning and procedural complications Foreign body	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.51% 2/395 • Number of events 2 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Nervous system disorders Febrile convulsion	0.71% 3/421 • Number of events 4 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.25% 1/395 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Cardiac disorders Aortic valve incompetence	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Bronchiolitis	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Croup infectious	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.51% 2/395 • Number of events 2 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Gastroenteritis	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Groin abscess	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.51% 2/395 • Number of events 2 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Neutropenic infection	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.21% 1/472 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Penile abscess	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Pneumonia	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.25% 1/395 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Pneumonia bacterial	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Respiratory syncytial virus infection	0.24% 1/421 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/395 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Staphylococcal abscess	0.00% 0/421 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.25% 1/395 • Number of events 1 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	0.00% 0/472 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.

Measure	Menactra Vaccine Group n=421 participants at risk Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months	Menactra + Pentacel Vaccine Group n=395 participants at risk Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months	Pentacel Vaccine Group n=472 participants at risk Study participants received only Pentacel vaccine at 15 to 18 months of age
General disorders Injection Site Tenderness	52.1% 219/420 • Number of events 219 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	61.6% 242/393 • Number of events 242 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	51.4% 238/463 • Number of events 238 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
General disorders Injection Site Erythema	25.2% 106/420 • Number of events 106 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	38.7% 152/393 • Number of events 152 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	31.1% 144/463 • Number of events 144 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Gastrointestinal disorders Vomiting	22.6% 95/420 • Number of events 95 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	17.3% 68/393 • Number of events 68 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	9.7% 46/472 • Number of events 46 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
General disorders Fever	16.9% 71/421 • Number of events 71 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	21.6% 85/394 • Number of events 85 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	12.3% 57/463 • Number of events 57 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Psychiatric disorders Crying abnormal	52.9% 222/420 • Number of events 222 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	52.2% 205/393 • Number of events 205 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	39.1% 181/463 • Number of events 181 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Nervous system disorders Drowsiness	49.8% 209/420 • Number of events 209 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	52.4% 206/393 • Number of events 206 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	30.0% 139/463 • Number of events 139 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Metabolism and nutrition disorders Appetite lost	43.3% 182/420 • Number of events 182 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	47.8% 188/393 • Number of events 188 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	35.2% 163/463 • Number of events 163 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Gastrointestinal disorders Diarrhoea	7.1% 30/421 • Number of events 35 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	5.3% 21/395 • Number of events 22 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	5.5% 26/472 • Number of events 29 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Gastrointestinal disorders Teething	7.4% 31/421 • Number of events 39 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	6.1% 24/395 • Number of events 33 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	8.9% 42/472 • Number of events 47 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
General disorders Pyrexia	10.0% 42/421 • Number of events 47 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	9.1% 36/395 • Number of events 40 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	5.3% 25/472 • Number of events 27 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Otitis media	13.8% 58/421 • Number of events 69 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	12.7% 50/395 • Number of events 57 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	5.9% 28/472 • Number of events 29 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 60/421 • Number of events 66 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	11.1% 44/395 • Number of events 48 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	6.6% 31/472 • Number of events 31 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.2% 43/421 • Number of events 48 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	11.9% 47/395 • Number of events 54 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	4.7% 22/472 • Number of events 22 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Infections and infestations Upper respiratory tract infection	14.3% 60/421 • Number of events 64 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	13.2% 52/395 • Number of events 58 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	10.6% 50/472 • Number of events 51 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
General disorders Injection-site Swelling	15.0% 63/420 • Number of events 63 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	23.2% 91/393 • Number of events 91 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	21.4% 99/463 • Number of events 99 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Psychiatric disorders Irritability	70.5% 296/420 • Number of events 296 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	72.3% 284/393 • Number of events 284 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.	58.5% 271/463 • Number of events 271 • Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.