Trial Outcomes & Findings for A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents (NCT NCT01424644)
NCT ID: NCT01424644
Last Updated: 2014-02-14
Results Overview
The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
801 participants
Primary outcome timeframe
1 month post Tdap vaccination.
Results posted on
2014-02-14
Participant Flow
Subjects were enrolled in two countries (US and Italy).
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
MenACWY-CRM+Tdap+HPV
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Overall Study
STARTED
|
402
|
399
|
|
Overall Study
COMPLETED
|
369
|
372
|
|
Overall Study
NOT COMPLETED
|
33
|
27
|
Reasons for withdrawal
| Measure |
MenACWY-CRM+Tdap+HPV
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
12
|
|
Overall Study
Lost to Follow-up
|
16
|
12
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Administrative Reason
|
1
|
0
|
|
Overall Study
Unable to Classify
|
1
|
0
|
Baseline Characteristics
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Baseline characteristics by cohort
| Measure |
MenACWY-CRM+Tdap+HPV
n=402 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=399 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Total
n=801 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
11.8 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
11.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post Tdap vaccination.Population: Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.
The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.
Outcome measures
| Measure |
MenACWY-CRM+Tdap+HPV
n=376 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=382 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
Day 1 (diphtheria) (N=375, 380)
|
5 percentages of subjects
Interval 3.0 to 8.0
|
3 percentages of subjects
Interval 2.0 to 5.0
|
|
Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
One month post dose (diphtheria)
|
95 percentages of subjects
Interval 93.0 to 97.0
|
82 percentages of subjects
Interval 78.0 to 86.0
|
|
Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
Day 1 (tetanus ) (N=375, 380)
|
28 percentages of subjects
Interval 24.0 to 33.0
|
28 percentages of subjects
Interval 23.0 to 32.0
|
|
Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
One month post dose (tetanus )
|
99 percentages of subjects
Interval 97.0 to 100.0
|
98 percentages of subjects
Interval 97.0 to 99.0
|
PRIMARY outcome
Timeframe: 1 month post Tdap vaccination.Population: Analysis was done on the Tdap per-protocol population.
The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.
Outcome measures
| Measure |
MenACWY-CRM+Tdap+HPV
n=376 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=382 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
PT (Day 1) (N= 375, 380)
|
4.77 EU/mL
Interval 4.11 to 5.53
|
4.16 EU/mL
Interval 3.59 to 4.82
|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
PT(One month post dose)
|
44 EU/mL
Interval 40.0 to 48.0
|
44 EU/mL
Interval 40.0 to 48.0
|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
FHA (Day 1) (N= 375, 380)
|
24 EU/mL
Interval 21.0 to 27.0
|
21 EU/mL
Interval 18.0 to 23.0
|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
FHA (One month post dose)
|
202 EU/mL
Interval 187.0 to 218.0
|
240 EU/mL
Interval 222.0 to 259.0
|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
PRN (Day 1) (N= 375, 380)
|
20 EU/mL
Interval 18.0 to 23.0
|
21 EU/mL
Interval 18.0 to 24.0
|
|
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
PRN (One month post dose)
|
330 EU/mL
Interval 300.0 to 363.0
|
403 EU/mL
Interval 367.0 to 443.0
|
SECONDARY outcome
Timeframe: 1 month post MenACWY-CRM vaccination.Population: Analysis was done on the MenACWY per-protocol population - all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at baseline and one month postvaccination for at least one serogroup, and had no major protocol violation as defined prior to unblinding.
The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.
Outcome measures
| Measure |
MenACWY-CRM+Tdap+HPV
n=371 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=99 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
Men A
|
35 Titers
Interval 29.0 to 42.0
|
2.13 Titers
Interval 1.97 to 2.31
|
|
Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
Men C (N=370, 97)
|
59 Titers
Interval 48.0 to 73.0
|
3.92 Titers
Interval 3.3 to 4.66
|
|
Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
Men W (N=369, 96)
|
61 Titers
Interval 53.0 to 69.0
|
12 Titers
Interval 9.26 to 17.0
|
|
Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
Men Y (N=369, 97)
|
48 Titers
Interval 40.0 to 58.0
|
3.54 Titers
Interval 2.9 to 4.31
|
SECONDARY outcome
Timeframe: Day 1-7 after any vaccination.Population: Analysis was done on solicited safety Set - All subjects in the exposed population who provided solicited AEs.
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.
Outcome measures
| Measure |
MenACWY-CRM+Tdap+HPV
n=389 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=385 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Local
|
209 Subjects
|
164 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Injection site pain
|
158 Subjects
|
134 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Injection site erythema
|
65 Subjects
|
25 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Injection site induration
|
61 Subjects
|
37 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Systemic
|
205 Subjects
|
179 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Chills
|
60 Subjects
|
50 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Nausea
|
54 Subjects
|
39 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Malaise
|
57 Subjects
|
44 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Myalgia
|
115 Subjects
|
101 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Arthralgia
|
35 Subjects
|
43 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Headache
|
113 Subjects
|
95 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Rash
|
4 Subjects
|
7 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Fever ≥ 38°C
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Other
|
88 Subjects
|
80 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Stayed home due to reaction
|
25 Subjects
|
33 Subjects
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Analgesic / Antipyretic medication used
|
74 Subjects
|
65 Subjects
|
SECONDARY outcome
Timeframe: Throughout the study (Day 1 to Day 211).Population: Analysis was done on overall safety population - All subjects in the exposed population who provided postvaccination and post-baseline safety data.
The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo. Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal - one subject due to treatment emergent AE and another subject prior to study vaccination on day 1.
Outcome measures
| Measure |
MenACWY-CRM+Tdap+HPV
n=396 Participants
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=397 Participants
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Any AEs
|
201 Subjects
|
197 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
At least possibly related AEs
|
17 Subjects
|
14 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Serious AEs
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
AEs leading to Premature Withdrawal
|
2 Subjects
|
0 Subjects
|
Adverse Events
MenACWY-CRM+Tdap+HPV
Serious events: 4 serious events
Other events: 288 other events
Deaths: 0 deaths
Placebo+Tdap+HPV
Serious events: 3 serious events
Other events: 248 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM+Tdap+HPV
n=396 participants at risk
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=397 participants at risk
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.25%
1/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.25%
1/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes mellitus
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.25%
1/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Psychiatric disorders
Aggression
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Renal and urinary disorders
Haematuria
|
0.25%
1/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
0.00%
0/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
Other adverse events
| Measure |
MenACWY-CRM+Tdap+HPV
n=396 participants at risk
Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
Placebo+Tdap+HPV
n=397 participants at risk
Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
|
|---|---|---|
|
General disorders
Injection site induration
|
17.4%
69/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
10.8%
43/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Gastrointestinal disorders
Nausea
|
14.9%
59/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
10.6%
42/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
General disorders
Chills
|
16.4%
65/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
12.6%
50/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
General disorders
Injection site erythema
|
19.9%
79/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
7.6%
30/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
General disorders
Injection site pain
|
48.7%
193/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
41.6%
165/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
General disorders
Malaise
|
14.9%
59/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
11.3%
45/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Infections and infestations
Pharyngitis
|
5.6%
22/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
5.3%
21/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.1%
40/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
11.8%
47/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.5%
117/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
27.5%
109/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
|
Nervous system disorders
Headache
|
32.3%
128/396 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
26.4%
105/397 • From day 1 through day 211.
Serious adverse events (SAEs) were collected from Day 1 through Day 211. Note: Among 801 subjects in the enrolled population (reported in the participant flow module), 793 subjects were exposed to the study vaccines.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60