Trial Outcomes & Findings for Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers (NCT NCT00422292)

Last Updated: 2016-04-14

Results Overview

Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1664 participants

Primary outcome timeframe

Day 30 after the 12-month vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.

A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented. 625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.

Participant milestones

Participant milestones
Measure	Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Study STARTED	257	664	246	476
Overall Study COMPLETED	239	598	224	452
Overall Study NOT COMPLETED	18	66	22	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Study Serious adverse events	1	4	0	0
Overall Study Adverse Event	1	0	1	0
Overall Study Protocol Violation	4	25	8	5
Overall Study Lost to Follow-up	6	12	6	6
Overall Study Withdrawal by Subject	6	25	7	13

Baseline Characteristics

Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Menactra® at 9 and 12 Months n=257 Participants Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months n=664 Participants Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months n=246 Participants Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=476 Participants Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Total n=1643 Participants Total of all reporting groups
Age, Categorical <=18 years	257 Participants n=5 Participants	664 Participants n=7 Participants	246 Participants n=5 Participants	476 Participants n=4 Participants	1643 Participants n=21 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	0 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	283.4 Days STANDARD_DEVIATION 11.3 • n=5 Participants	283.0 Days STANDARD_DEVIATION 11.3 • n=7 Participants	282.8 Days STANDARD_DEVIATION 10.3 • n=5 Participants	374.8 Days STANDARD_DEVIATION 8.6 • n=4 Participants	283.4 Days STANDARD_DEVIATION 11.3 • n=21 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	349 Participants n=7 Participants	118 Participants n=5 Participants	231 Participants n=4 Participants	817 Participants n=21 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	315 Participants n=7 Participants	128 Participants n=5 Participants	245 Participants n=4 Participants	826 Participants n=21 Participants
Region of Enrollment United States	257 participants n=5 Participants	664 participants n=7 Participants	246 participants n=5 Participants	476 participants n=4 Participants	1643 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 30 after the 12-month vaccination

Population: Antibody responses were evaluated in the per-protocol population.

Outcome measures

Outcome measures
Measure	Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months n=498 Participants Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=399 Participants Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) Measles	—	98 Percentage of Participants	—	98 Percentage of Participants
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) Mumps	—	95 Percentage of Participants	—	95 Percentage of Participants
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) Rubella	—	93 Percentage of Participants	—	88 Percentage of Participants
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) Varicella	—	93 Percentage of Participants	—	87 Percentage of Participants

PRIMARY outcome

Timeframe: Day 30 after the 12-month vaccination

Population: Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.

Outcome measures

Outcome measures
Measure	Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months n=191 Participants Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=399 Participants Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 4	—	—	1.82 Titers Interval 1.62 to 2.05	3.33 Titers Interval 3.06 to 3.62
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 6B	—	—	5.40 Titers Interval 4.79 to 6.09	10.8 Titers Interval 9.89 to 11.7
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 9V	—	—	2.06 Titers Interval 1.84 to 2.3	3.57 Titers Interval 3.29 to 3.88
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 14	—	—	6.73 Titers Interval 5.95 to 7.6	10.5 Titers Interval 9.65 to 11.3
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 18C	—	—	1.58 Titers Interval 1.43 to 1.75	2.91 Titers Interval 2.66 to 3.18
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 19F	—	—	2.50 Titers Interval 2.24 to 2.78	4.03 Titers Interval 3.74 to 4.34
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Serotype 23F	—	—	4.62 Titers Interval 4.06 to 5.25	7.03 Titers Interval 6.39 to 7.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 30 after 12-month vaccination

Outcome measures

Outcome measures
Measure	Group 1: Menactra® at 9 and 12 Months Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months n=191 Participants Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=399 Participants Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 9V	—	—	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 14	—	—	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype18C	—	—	98 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 19F	—	—	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 23F	—	—	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 4	—	—	98 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Serotype 6B	—	—	100 Percentage of Participants	100 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 0 to 7 after vaccination

Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling. Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.

Outcome measures

Outcome measures
Measure	Group 1: Menactra® at 9 and 12 Months n=257 Participants Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months n=616 Participants Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months n=246 Participants Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Solicited Injection Site Reacton	46 Percentage of Participants	43 Percentage of Participants	49 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Tenderness	35 Percentage of Participants	33 Percentage of Participants	38 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Tenderness (Cries when limb is moved)	0 Percentage of Participants	1 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Erythema	23 Percentage of Participants	20 Percentage of Participants	23 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Erythema (≥ 2.0 in)	2 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Swelling	13 Percentage of Participants	11 Percentage of Participants	9 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Swelling (≥ 2.0 in)	1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Solicited Systemic Reaction	66 Percentage of Participants	69 Percentage of Participants	71 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Fever	10 Percentage of Participants	13 Percentage of Participants	13 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Fever (> 103.1 ºF or > 39.5 ºC)	0 Percentage of Participants	1 Percentage of Participants	1 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Vomiting	17 Percentage of Participants	12 Percentage of Participants	15 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Vomiting	1 Percentage of Participants	1 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Crying Abnormal	37 Percentage of Participants	34 Percentage of Participants	34 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Crying Abnormal (> 3 hours)	3 Percentage of Participants	3 Percentage of Participants	2 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Irritability	56 Percentage of Participants	56 Percentage of Participants	51 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Irritability (Inconsolable)	5 Percentage of Participants	3 Percentage of Participants	2 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Drowsiness	33 Percentage of Participants	32 Percentage of Participants	35 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Drowsiness (Sleeps most of time)	1 Percentage of Participants	1 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Any Appetite Lost	26 Percentage of Participants	26 Percentage of Participants	26 Percentage of Participants	—
Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)	1 Percentage of Participants	2 Percentage of Participants	0 Percentage of Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 0 to 7 after vaccination

Population: Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.

Outcome measures

Outcome measures
Measure	Group 1: Menactra® at 9 and 12 Months n=257 Participants Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months n=572 Participants Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months n=246 Participants Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=476 Participants Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Erythema	0 Percentage of Participants	0 Percentage of Participants	28 Percentage of Participants	34 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Drowsiness	25 Percentage of Participants	32 Percentage of Participants	34 Percentage of Participants	39 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Drowsiness (Sleeps most of time)	0 Percentage of Participants	1 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Solicited Injection Site Reaction - Menactra	44 Percentage of Participants	46 Percentage of Participants	57 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Tenderness	0 Percentage of Participants	0 Percentage of Participants	49 Percentage of Participants	52 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Tenderness (Cries when limb is moved)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Erythema (≥ 2.0 in)	0 Percentage of Participants	0 Percentage of Participants	3 Percentage of Participants	3 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Swelling	0 Percentage of Participants	0 Percentage of Participants	17 Percentage of Participants	22 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Swelling (≥ 2.0 in)	0 Percentage of Participants	0 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Solicited Injection Site Reaction - MMRV	0 Percentage of Participants	38 Percentage of Participants	0 Percentage of Participants	49 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Solicited Injection Site Reaction - PCV	0 Percentage of Participants	0 Percentage of Participants	54 Percentage of Participants	62 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Solicited Systemic Reaction	56 Percentage of Participants	70 Percentage of Participants	69 Percentage of Participants	77 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Fever	10 Percentage of Participants	21 Percentage of Participants	16 Percentage of Participants	24 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Fever (> 103.1 ºF or > 39.5 ºC)	0 Percentage of Participants	3 Percentage of Participants	3 Percentage of Participants	3 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Vomiting	7 Percentage of Participants	10 Percentage of Participants	7 Percentage of Participants	10 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Vomiting	0 Percentage of Participants	1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Crying Abnormal	22 Percentage of Participants	41 Percentage of Participants	35 Percentage of Participants	39 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Crying Abnormal (> 3 hours)	1 Percentage of Participants	3 Percentage of Participants	2 Percentage of Participants	2 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Irritability	43 Percentage of Participants	58 Percentage of Participants	60 Percentage of Participants	62 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Irritability (Inconsolable)	4 Percentage of Participants	4 Percentage of Participants	4 Percentage of Participants	4 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Any Appetite Lost	24 Percentage of Participants	32 Percentage of Participants	27 Percentage of Participants	29 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)	1 Percentage of Participants	2 Percentage of Participants	1 Percentage of Participants	2 Percentage of Participants

Adverse Events

Group 1: Menactra® at 9 and 12 Months

Serious events: 14 serious events

Other events: 91 other events

Deaths: 0 deaths

Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month

Serious events: 24 serious events

Other events: 185 other events

Deaths: 0 deaths

Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months

Serious events: 10 serious events

Other events: 77 other events

Deaths: 0 deaths

Group 4: MMRV + PCV at 12 Months

Serious events: 17 serious events

Other events: 148 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Menactra® at 9 and 12 Months n=257 participants at risk Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month n=664 participants at risk；n=616 participants at risk Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months n=246 participants at risk Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=476 participants at risk Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Gastrointestinal disorders Diarrhoea	7.0% 18/257 • Number of events 21 • Adverse events data were collected for 6 months after the last vaccination.	5.7% 38/664 • Number of events 42 • Adverse events data were collected for 6 months after the last vaccination.	4.9% 12/246 • Number of events 12 • Adverse events data were collected for 6 months after the last vaccination.	6.1% 29/476 • Number of events 33 • Adverse events data were collected for 6 months after the last vaccination.
Gastrointestinal disorders Teething	5.1% 13/257 • Number of events 16 • Adverse events data were collected for 6 months after the last vaccination.	4.1% 27/664 • Number of events 32 • Adverse events data were collected for 6 months after the last vaccination.	6.9% 17/246 • Number of events 20 • Adverse events data were collected for 6 months after the last vaccination.	3.2% 15/476 • Number of events 17 • Adverse events data were collected for 6 months after the last vaccination.
General disorders Pyrexia	3.9% 10/257 • Number of events 10 • Adverse events data were collected for 6 months after the last vaccination.	2.1% 14/664 • Number of events 15 • Adverse events data were collected for 6 months after the last vaccination.	0.81% 2/246 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.	10.1% 48/476 • Number of events 51 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Nasopharyngitis	5.1% 13/257 • Number of events 13 • Adverse events data were collected for 6 months after the last vaccination.	2.7% 18/664 • Number of events 18 • Adverse events data were collected for 6 months after the last vaccination.	2.8% 7/246 • Number of events 7 • Adverse events data were collected for 6 months after the last vaccination.	2.1% 10/476 • Number of events 11 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Otitis media	9.3% 24/257 • Number of events 25 • Adverse events data were collected for 6 months after the last vaccination.	7.8% 52/664 • Number of events 52 • Adverse events data were collected for 6 months after the last vaccination.	8.9% 22/246 • Number of events 22 • Adverse events data were collected for 6 months after the last vaccination.	4.2% 20/476 • Number of events 20 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Upper respiratory tract infection	8.6% 22/257 • Number of events 22 • Adverse events data were collected for 6 months after the last vaccination.	7.5% 50/664 • Number of events 51 • Adverse events data were collected for 6 months after the last vaccination.	10.2% 25/246 • Number of events 26 • Adverse events data were collected for 6 months after the last vaccination.	4.0% 19/476 • Number of events 19 • Adverse events data were collected for 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 13/257 • Number of events 13 • Adverse events data were collected for 6 months after the last vaccination.	4.2% 28/664 • Number of events 29 • Adverse events data were collected for 6 months after the last vaccination.	2.4% 6/246 • Number of events 7 • Adverse events data were collected for 6 months after the last vaccination.	3.4% 16/476 • Number of events 16 • Adverse events data were collected for 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.4% 14/257 • Number of events 15 • Adverse events data were collected for 6 months after the last vaccination.	3.8% 25/664 • Number of events 27 • Adverse events data were collected for 6 months after the last vaccination.	3.3% 8/246 • Number of events 8 • Adverse events data were collected for 6 months after the last vaccination.	4.6% 22/476 • Number of events 22 • Adverse events data were collected for 6 months after the last vaccination.

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	Group 1: Menactra® at 9 and 12 Months n=257 participants at risk Participants who received only Menactra® vaccination at 9 and 12 months of age	Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month n=664 participants at risk；n=616 participants at risk Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age	Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months n=246 participants at risk Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age	Group 4: MMRV + PCV at 12 Months n=476 participants at risk Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Congenital, familial and genetic disorders Congenital spinal cord anomaly	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Eye disorders Conjunctivitis	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Gastrointestinal disorders Intussusception	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Gastrointestinal disorders Melaena	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.21% 1/476 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Bacterial sepsis	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Bronchiolitis	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.63% 3/476 • Number of events 3 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Croup infectious	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Febrile infection	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Gastroenteritis	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.32% 2/616 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.	0.81% 2/246 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.	0.42% 2/476 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Gastroenteritis viral	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.21% 1/476 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Infected Cyst	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Kawasaki's diseas	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Lobar pneumonia	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.21% 1/476 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Otitis media acute	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Periorbital cellulitis	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Periumbilical abscess	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Pneumonia	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.49% 3/616 • Number of events 3 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.63% 3/476 • Number of events 3 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Respiratory syncytial virus infection	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Respiratory tract infection viral	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Staphylococcal abscess	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Staphylococcal infection	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Streptococcal bacteraemia	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Subcutaneous abscess	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Infections and infestations Urinary tract infection	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Injury, poisoning and procedural complications Accidental overdose	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Injury, poisoning and procedural complications Closed head injury	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Injury, poisoning and procedural complications Foreign body trauma	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Craniosynostosis	0.39% 1/257 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Nervous system disorders Autism	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.21% 1/476 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.
Nervous system disorders Epilepsy	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Nervous system disorders Febrile convulsion	1.2% 3/257 • Number of events 3 • Adverse events data were collected for 6 months after the last vaccination.	0.97% 6/616 • Number of events 6 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.84% 4/476 • Number of events 4 • Adverse events data were collected for 6 months after the last vaccination.
Nervous system disorders Myoclonic epilepsy	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/616 • Adverse events data were collected for 6 months after the last vaccination.	0.41% 1/246 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/476 • Adverse events data were collected for 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/257 • Adverse events data were collected for 6 months after the last vaccination.	0.16% 1/616 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.42% 2/476 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.78% 2/257 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.	0.32% 2/616 • Number of events 2 • Adverse events data were collected for 6 months after the last vaccination.	0.00% 0/246 • Adverse events data were collected for 6 months after the last vaccination.	0.21% 1/476 • Number of events 1 • Adverse events data were collected for 6 months after the last vaccination.