Trial Outcomes & Findings for ProQuad® Intramuscular vs Subcutaneous (NCT NCT00402831)
NCT ID: NCT00402831
Last Updated: 2018-08-13
Results Overview
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
Week 10 (6 weeks after Dose 2 on Week 4)
Results posted on
2018-08-13
Participant Flow
A total of 411 male and female participants (12 to 18 months of age) were selected for study entry at 33 sites in France. A total of 405 participants were randomized and received 2 doses of study drug.
Participant milestones
| Measure |
Intramuscular ProQuad®
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
203
|
|
Overall Study
ProQuad® Dose 1 (Day 1)
|
202
|
203
|
|
Overall Study
ProQuad® Dose 1 (Day 30)
|
202
|
203
|
|
Overall Study
COMPLETED
|
201
|
200
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Intramuscular ProQuad®
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Non-compliance with protocol
|
0
|
1
|
Baseline Characteristics
ProQuad® Intramuscular vs Subcutaneous
Baseline characteristics by cohort
| Measure |
Intramuscular ProQuad®
n=202 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=203 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.72 Months
STANDARD_DEVIATION 1.44 • n=5 Participants
|
13.65 Months
STANDARD_DEVIATION 1.53 • n=7 Participants
|
13.68 Months
STANDARD_DEVIATION 1.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10 (6 weeks after Dose 2 on Week 4)Population: Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=153 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=148 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Measles
|
100 Percentage of participants
Interval 97.6 to 100.0
|
100 Percentage of participants
Interval 97.5 to 100.0
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Mumps
|
99.3 Percentage of participants
Interval 96.4 to 100.0
|
99.3 Percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Rubella
|
100 Percentage of participants
Interval 97.2 to 100.0
|
99.2 Percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Varicella
|
100 Percentage of participants
Interval 97.4 to 100.0
|
99.3 Percentage of participants
Interval 95.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.
Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=153 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=149 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Measles
|
100 Percentage of participants
Interval 97.6 to 100.0
|
97.3 Percentage of participants
Interval 93.2 to 99.3
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Mumps
|
97.4 Percentage of participants
Interval 93.4 to 99.3
|
91.3 Percentage of participants
Interval 85.5 to 95.3
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Rubella
|
98.4 Percentage of participants
Interval 94.5 to 99.8
|
100 Percentage of participants
Interval 97.3 to 100.0
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Varicella
|
98.6 Percentage of participants
Interval 94.9 to 99.8
|
98.5 Percentage of participants
Interval 94.8 to 99.8
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who were initially seronegative to measles and who had post-vaccination serology results were included.
Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=153 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=148 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose
|
4058.7 Antibody titres (mIU/mL)
Interval 3643.1 to 4521.8
|
3327.0 Antibody titres (mIU/mL)
Interval 2835.4 to 3903.9
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.
Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres \<10 ELISA Ab units mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=152 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=149 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose
|
120.0 Antibody titres (ELISA Ab units/mL)
Interval 102.2 to 140.9
|
101.9 Antibody titres (ELISA Ab units/mL)
Interval 84.2 to 123.2
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.
Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=129 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=133 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose
|
46.9 Antibody titres (IU/mL)
Interval 39.7 to 55.4
|
50.9 Antibody titres (IU/mL)
Interval 44.9 to 57.7
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.
Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=138 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=136 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose
|
25.0 Antibody titres (gpELISA units/mL)
Interval 22.5 to 27.7
|
23.6 Antibody titres (gpELISA units/mL)
Interval 20.9 to 26.7
|
SECONDARY outcome
Timeframe: Week 10 (6 weeks after Dose 2 on Week 4)Population: Participants who were initially seronegative to measles and who had post-vaccination serology results were included.
Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre \<255 mIU/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=153 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=147 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment
|
3953.7 Antibody titres (mIU/mL)
Interval 3497.2 to 4469.9
|
3748.6 Antibody titres (mIU/mL)
Interval 3270.9 to 4296.0
|
SECONDARY outcome
Timeframe: Week 10 (6 weeks after Dose 2 on Week 4)Population: Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.
Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre \<10 ELISA Ab units mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=152 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=148 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment
|
157.9 Antibody titres (ELISA Ab units/mL)
Interval 138.6 to 180.0
|
168.8 Antibody titres (ELISA Ab units/mL)
Interval 146.9 to 194.0
|
SECONDARY outcome
Timeframe: Week 10 (6 weeks after Dose 2 on Week 4)Population: Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.
Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre \<10 IU/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=129 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=132 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment
|
92.8 Antibody titres (IU/mL)
Interval 82.4 to 104.5
|
94.2 Antibody titres (IU/mL)
Interval 83.2 to 106.6
|
SECONDARY outcome
Timeframe: Week 10 (6 weeks after Dose 2 on Week 4)Population: Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.
Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre \<1.25 gpELISA units/mL.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=138 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=134 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment
|
358.1 Antibody titres (gpELISA units/mL)
Interval 300.1 to 427.4
|
261.8 Antibody titres (gpELISA units/mL)
Interval 216.7 to 316.4
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)Population: All participants who received at least one dose of study drug and had safety follow-up data are included.
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=202 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=203 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
Injection-site AEs
|
17.8 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
Vaccine-related systemic AEs
|
8.9 Percentage of participants
|
8.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)Population: All participants who received at least one dose of study drug and had safety follow-up data are included.
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=201 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=200 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
Injection-site AEs
|
20.4 Percentage of participants
|
29.5 Percentage of participants
|
|
Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
Vaccine-related systemic AEs
|
6.0 Percentage of participants
|
5.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.
Outcome measures
| Measure |
Intramuscular ProQuad®
n=202 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days.
|
Subcutaneous ProQuad®
n=203 Participants
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days.
|
|---|---|---|
|
Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
IM ProQuad® Arm: Dose 1
Serious events: 2 serious events
Other events: 153 other events
Deaths: 0 deaths
SC ProQuad® Arm: Dose 1
Serious events: 2 serious events
Other events: 166 other events
Deaths: 0 deaths
IM ProQuad® Arm: Dose 2
Serious events: 1 serious events
Other events: 141 other events
Deaths: 0 deaths
SC ProQuad® Arm: Dose 2
Serious events: 1 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IM ProQuad® Arm: Dose 1
n=202 participants at risk
All participants who received the first dose of ProQuad® via IM injection are included.
|
SC ProQuad® Arm: Dose 1
n=203 participants at risk
All participants who received the first dose of ProQuad® via SC injection are included.
|
IM ProQuad® Arm: Dose 2
n=201 participants at risk
All participants who received the second dose of ProQuad® via IM injection are included.
|
SC ProQuad® Arm: Dose 2
n=200 participants at risk
All participants who received the second dose of ProQuad® via SC injection are included.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.49%
1/203 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.50%
1/201 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/200 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Gastroenteritis viral
|
0.50%
1/202 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/201 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/200 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Viral tonsillitis
|
0.50%
1/202 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/201 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/200 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.49%
1/203 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/201 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/200 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/201 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.50%
1/200 • Number of events 1 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
Other adverse events
| Measure |
IM ProQuad® Arm: Dose 1
n=202 participants at risk
All participants who received the first dose of ProQuad® via IM injection are included.
|
SC ProQuad® Arm: Dose 1
n=203 participants at risk
All participants who received the first dose of ProQuad® via SC injection are included.
|
IM ProQuad® Arm: Dose 2
n=201 participants at risk
All participants who received the second dose of ProQuad® via IM injection are included.
|
SC ProQuad® Arm: Dose 2
n=200 participants at risk
All participants who received the second dose of ProQuad® via SC injection are included.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
11/202 • Number of events 11 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.9%
12/203 • Number of events 14 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
3.5%
7/201 • Number of events 7 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.0%
12/200 • Number of events 12 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Gastrointestinal disorders
Teething
|
9.4%
19/202 • Number of events 21 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
8.4%
17/203 • Number of events 19 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.5%
11/201 • Number of events 12 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.0%
12/200 • Number of events 13 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
General disorders
Injection site erythema
|
6.9%
14/202 • Number of events 14 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
19.7%
40/203 • Number of events 42 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
15.4%
31/201 • Number of events 31 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
27.0%
54/200 • Number of events 54 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
General disorders
Injection site pain
|
11.4%
23/202 • Number of events 23 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.9%
12/203 • Number of events 12 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
10.0%
20/201 • Number of events 20 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
10.0%
20/200 • Number of events 20 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
General disorders
Pyrexia
|
56.9%
115/202 • Number of events 158 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
61.6%
125/203 • Number of events 161 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
44.3%
89/201 • Number of events 124 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
41.0%
82/200 • Number of events 113 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Bronchitis
|
9.9%
20/202 • Number of events 20 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
7.9%
16/203 • Number of events 18 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
4.5%
9/201 • Number of events 9 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.0%
12/200 • Number of events 14 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Ear infection
|
10.9%
22/202 • Number of events 22 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
9.4%
19/203 • Number of events 20 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
10.4%
21/201 • Number of events 21 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
11.0%
22/200 • Number of events 24 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
19/202 • Number of events 19 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
8.9%
18/203 • Number of events 20 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
7.5%
15/201 • Number of events 15 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
8.5%
17/200 • Number of events 18 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Rhinitis
|
6.9%
14/202 • Number of events 15 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.4%
13/203 • Number of events 14 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/201 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/200 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
7/202 • Number of events 7 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.4%
13/203 • Number of events 14 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.5%
11/201 • Number of events 11 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
3.5%
7/200 • Number of events 8 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
General disorders
Injection site swelling
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
6.0%
12/201 • Number of events 12 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
12.5%
25/200 • Number of events 25 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.5%
11/201 • Number of events 11 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
5.0%
10/200 • Number of events 10 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/202 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
0.00%
0/203 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
7.5%
15/201 • Number of events 16 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
3.0%
6/200 • Number of events 7 • Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Event data are presented separately for Dose 1 and Dose 2.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sanofi Pasteur MSD shall have sixty days to review these documents and may refuse to give its consent in part or whole for confidential reasons (including but not limited to intellectual property rights, whether patentable or not).
- Publication restrictions are in place
Restriction type: OTHER