Trial Outcomes & Findings for Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® (NCT NCT00355121)
NCT ID: NCT00355121
Last Updated: 2011-08-24
Results Overview
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
882 participants
Primary outcome timeframe
Day 30 post-vaccination (Visit 1)
Results posted on
2011-08-24
Participant Flow
Participants were enrolled from 16 October 2006 to 21 June 2007 in 45 medical centers in the US.
A total of 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.
Participant milestones
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Overall Study
STARTED
|
353
|
353
|
175
|
|
Overall Study
COMPLETED
|
332
|
324
|
170
|
|
Overall Study
NOT COMPLETED
|
21
|
29
|
5
|
Reasons for withdrawal
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Overall Study
Did not receive study vaccine
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
7
|
9
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
2
|
|
Overall Study
Serious adverse events
|
0
|
2
|
0
|
Baseline Characteristics
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Baseline characteristics by cohort
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=353 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=353 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=175 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
Total
n=881 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
353 Participants
n=93 Participants
|
353 Participants
n=4 Participants
|
175 Participants
n=27 Participants
|
881 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age Continuous
|
4.5 Years
STANDARD_DEVIATION 0.48 • n=93 Participants
|
4.5 Years
STANDARD_DEVIATION 0.51 • n=4 Participants
|
4.5 Years
STANDARD_DEVIATION 0.49 • n=27 Participants
|
4.5 Years
STANDARD_DEVIATION 0.50 • n=483 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
427 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=93 Participants
|
171 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
454 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
353 participants
n=93 Participants
|
353 participants
n=4 Participants
|
175 participants
n=27 Participants
|
881 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccination (Visit 1)Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=250 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=238 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Diphtheria Antibody Concentration ≥ 1.0 IU/mL
|
249 Participants
|
238 Participants
|
—
|
|
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Tetanus Antibody Concentration ≥ 1.0 IU/mL
|
246 Participants
|
236 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 30 post-vaccination (Visit 1)Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=238 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=121 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serogroup A (N = 0, 131, 104)
|
—
|
10.8 Titers
Interval 8.7 to 13.3
|
10.4 Titers
Interval 8.1 to 13.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serogroup C (N = 0, 131, 103)
|
—
|
8.1 Titers
Interval 6.3 to 10.5
|
7.8 Titers
Interval 5.8 to 10.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serogroup Y (N = 0, 131, 104)
|
—
|
18.1 Titers
Interval 14.2 to 22.9
|
26.2 Titers
Interval 20.0 to 34.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serogroup W-135 (N = 0, 131, 104)
|
—
|
22.8 Titers
Interval 18.5 to 28.1
|
21.7 Titers
Interval 16.6 to 28.4
|
SECONDARY outcome
Timeframe: Day 30 post-vaccination 1Population: Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=250 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=238 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Pertussis toxoid (PT; N = 243, 236, 0)
|
70.0 EU/mL
Interval 63.0 to 77.8
|
71.0 EU/mL
Interval 63.8 to 79.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Filamentous hemagglutinin (FHA; N = 246, 237, 0)
|
133 EU/mL
Interval 117.0 to 152.0
|
145 EU/mL
Interval 127.0 to 165.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Fimbriae Types 2 and 3 (FIM; N = 243, 238, 0)
|
123 EU/mL
Interval 92.5 to 164.0
|
113 EU/mL
Interval 84.0 to 151.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Pertactin (PRN; N = 247, 238, 0)
|
115 EU/mL
Interval 97.0 to 136.0
|
118 EU/mL
Interval 102.0 to 137.0
|
—
|
SECONDARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=250 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=121 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serogroup W-135 (N = 138, 0, 104)
|
8.4 Titers
Interval 6.7 to 10.6
|
—
|
21.7 Titers
Interval 16.6 to 28.4
|
|
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serogroup A (N = 137, 0, 104)
|
6.7 Titers
Interval 5.7 to 8.0
|
—
|
10.4 Titers
Interval 8.1 to 13.3
|
|
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serogroup C (N = 138, 0, 103)
|
3.3 Titers
Interval 2.7 to 3.9
|
—
|
7.8 Titers
Interval 5.8 to 10.7
|
|
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serogroup Y (N = 138, 0, 104)
|
6.5 Titers
Interval 5.1 to 8.2
|
—
|
26.2 Titers
Interval 20.0 to 34.4
|
SECONDARY outcome
Timeframe: Day 0 through Day 7 post-vaccination at Visit 1Population: Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=341 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=344 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
|
27 Participants
|
18 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30 post-vaccinationPopulation: Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2
Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=250 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=238 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=121 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Type 3 (N = 245, 236, 120)
|
6777.5 Titers
Interval 5766.9 to 7965.2
|
7815.9 Titers
Interval 6601.0 to 9254.5
|
5843 Titers
Interval 4523.4 to 7547.6
|
|
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Type 1 (N = 243, 235, 120)
|
5094.8 Titers
Interval 4427.8 to 5862.4
|
5767 Titers
Interval 4982.7 to 6674.9
|
4885.1 Titers
Interval 4013.2 to 5946.4
|
|
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Type 2 (N = 245, 237, 120)
|
5209.5 Titers
Interval 4549.0 to 5966.0
|
6195.6 Titers
Interval 5325.3 to 7208.1
|
5373.6 Titers
Interval 4461.0 to 6472.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 through Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=341 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=344 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=169 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Pain: DAPTACEL
|
236 Participants
|
229 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Pain (Incapacitating): DAPTACEL
|
2 Participants
|
2 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Swelling (≥ 2 in): DAPTACEL
|
54 Participants
|
41 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Erythema: Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
103 Participants
|
31 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Erythema (≥ 2 in): Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
16 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Pain: IPOL
|
207 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
98 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Pain (Incapacitating): IPOL
|
3 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Erythema: IPOL
|
59 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
23 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Erythema (≥ 2 in): IPOL
|
10 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Erythema: DAPTACEL
|
161 Participants
|
161 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Erythema (≥ 2 in): DAPTACEL
|
75 Participants
|
73 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Swelling: DAPTACEL
|
113 Participants
|
109 Participants
|
NA Participants
DAPTACEL was not administered at Visit 1
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Pain: Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
201 Participants
|
93 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Pain (Incapacitating): Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Swelling: Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
66 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Swelling (≥ 2 in): Menactra
|
NA Participants
Menactra was not administered at Visit 1
|
18 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Injection Site Swelling: IPOL
|
39 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Swelling (≥ 2 in): IPOL
|
8 Participants
|
NA Participants
IPOL was not administered at Visit 1
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Fever
|
27 Participants
|
18 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF)
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Headache
|
48 Participants
|
42 Participants
|
22 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Headache (Prevents daily activities)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Malaise
|
86 Participants
|
81 Participants
|
44 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Malaise (Prevents daily activities)
|
8 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Any Myalgia
|
153 Participants
|
123 Participants
|
44 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Grade 3 Myalgia (Prevents daily activities)
|
6 Participants
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 through Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=328 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=327 Participants
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=165 Participants
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Injection Site Erythema
|
80 Participants
|
54 Participants
|
42 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Erythema (≥ 2 inches)
|
24 Participants
|
2 Participants
|
18 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Swelling (≥ 2 inches)
|
19 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Fever
|
12 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Headache (Prevents daily activities)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Malaise
|
46 Participants
|
47 Participants
|
37 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Malaise (Prevents daily activities)
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Myalgia
|
78 Participants
|
55 Participants
|
42 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Myalgia (Prevents daily activities)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Injection Site Pain
|
168 Participants
|
128 Participants
|
85 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Pain (Incapacitating)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Injection Site Swelling
|
58 Participants
|
31 Participants
|
32 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Grade 3 Fever (> 39.5 ºC or ≥ 103.2 ºF)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Any Headache
|
27 Participants
|
21 Participants
|
12 Participants
|
Adverse Events
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
Serious events: 0 serious events
Other events: 236 other events
Deaths: 0 deaths
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
Serious events: 2 serious events
Other events: 229 other events
Deaths: 0 deaths
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=341 participants at risk
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=344 participants at risk
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=169 participants at risk
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/341 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.29%
1/344 • Number of events 1 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.00%
0/169 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/341 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.00%
0/344 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.00%
0/341 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.29%
1/344 • Number of events 1 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.00%
0/169 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
Other adverse events
| Measure |
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30
n=341 participants at risk
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
|
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30
n=344 participants at risk
Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
|
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
n=169 participants at risk
Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
|
|---|---|---|---|
|
General disorders
Injection Site Pain
|
71.7%
236/329 • Number of events 236 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
69.4%
229/330 • Number of events 229 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
59.0%
98/166 • Number of events 98 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Injection Site Erythema
|
48.8%
161/330 • Number of events 161 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
48.8%
161/330 • Number of events 161 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
25.8%
42/163 • Number of events 42 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Injection Site Swelling
|
34.2%
113/330 • Number of events 113 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
33.1%
109/329 • Number of events 109 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
19.8%
32/162 • Number of events 32 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Fever
|
8.2%
27/328 • Number of events 27 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
5.5%
18/325 • Number of events 18 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
8.0%
13/163 • Number of events 13 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Malaise
|
26.0%
86/331 • Number of events 86 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
24.5%
81/330 • Number of events 81 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
26.7%
44/165 • Number of events 44 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.2%
153/331 • Number of events 153 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
37.3%
123/330 • Number of events 123 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
26.7%
44/165 • Number of events 44 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Nervous system disorders
Headache
|
14.5%
48/331 • Number of events 48 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
12.7%
42/330 • Number of events 42 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
13.3%
22/165 • Number of events 22 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
14/341 • Number of events 14 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
5.2%
18/344 • Number of events 18 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
5.9%
10/169 • Number of events 10 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Injection Site Induration
|
6.5%
22/341 • Number of events 22 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
4.7%
16/344 • Number of events 16 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
7.1%
12/169 • Number of events 12 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
General disorders
Injection Site Pruritus
|
5.3%
18/341 • Number of events 18 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
4.4%
15/344 • Number of events 15 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
0.00%
0/169 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
38/341 • Number of events 38 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
11.4%
39/343 • Number of events 39 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
13.6%
23/169 • Number of events 23 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.4%
15/341 • Number of events 15 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
6.4%
22/343 • Number of events 22 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
5.3%
9/169 • Number of events 9 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
9/341 • Number of events 9 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
3.5%
12/343 • Number of events 12 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
6.5%
11/169 • Number of events 11 • Adverse event data were collected from the day of vaccination for up to 6 months post-vaccination at Visit 2.
|
Additional Information
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