Trial Outcomes & Findings for Safety Study of ProQuad® rHA in Infants (V221-037) (NCT NCT00560755)
NCT ID: NCT00560755
Last Updated: 2017-10-17
Results Overview
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3388 participants
Primary outcome timeframe
Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Results posted on
2017-10-17
Participant Flow
Healthy pediatric participants were enrolled at 84 study centers in 7 European countries.
Participant milestones
| Measure |
ProQuad®
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Overall Study
STARTED
|
3388
|
|
Overall Study
ProQuad® Dose 1 and Dose 2
|
3346
|
|
Overall Study
COMPLETED
|
3328
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
ProQuad®
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Overall Study
Protocol Violation
|
15
|
|
Overall Study
Withdrawal by Subject
|
26
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Safety Study of ProQuad® rHA in Infants (V221-037)
Baseline characteristics by cohort
| Measure |
ProQuad®
n=3388 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Age, Continuous
|
14.6 Months
STANDARD_DEVIATION 2.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1650 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1738 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2
|
57.66 Percentage of Participants
Interval 55.96 to 59.34
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2
|
41.77 Percentage of Participants
Interval 40.09 to 43.47
|
PRIMARY outcome
Timeframe: Up to Day 46 (for 4 days following ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
Injection-site erythema
|
30.46 Percentage of Participants
Interval 28.9 to 32.05
|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
Injection-site swelling
|
13.23 Percentage of Participants
Interval 12.09 to 14.42
|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2
Injection-site pain
|
11.49 Percentage of Participants
Interval 10.43 to 12.62
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2
|
1.65 Percentage of Participants
Interval 1.24 to 2.14
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2
|
0.03 Percentage of Participants
Interval 0.0 to 0.17
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2
|
40.42 Percentage of Participants
Interval 38.76 to 42.11
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2
|
13.44 Percentage of Participants
Interval 12.3 to 14.64
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
Measles-like rash
|
1.62 Percentage of Participants
Interval 1.22 to 2.1
|
|
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
Rubella-like rash
|
0.57 Percentage of Participants
Interval 0.34 to 0.89
|
|
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
Varicella-like rash
|
0.63 Percentage of Participants
Interval 0.39 to 0.96
|
|
Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2
Zoster-like rash
|
0.03 Percentage of Participants
Interval 0.0 to 0.17
|
PRIMARY outcome
Timeframe: Up to Day 70 (up to 28 days after ProQuad® Dose 2)Population: All participants who received the second ProQuad® dose and had safety follow-up data available are included.
The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2
|
0.03 Percentage of Participants
Interval 0.0 to 0.17
|
PRIMARY outcome
Timeframe: Up to Day 84 (up to 42 days after ProQuad® Dose 2)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2
|
0.66 Percentage of Participants
Interval 0.41 to 0.99
|
PRIMARY outcome
Timeframe: Up to Day 84 (up to 42 days after ProQuad® Dose 2)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.
Outcome measures
| Measure |
ProQuad®
n=3342 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2
|
0.21 Percentage of Participants
Interval 0.08 to 0.43
|
SECONDARY outcome
Timeframe: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.
Outcome measures
| Measure |
ProQuad®
n=3376 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
Injection-site erythema
|
14.31 Percentage of Participants
Interval 13.14 to 15.53
|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
Injection-site swelling
|
5.57 Percentage of Participants
Interval 4.82 to 6.4
|
|
Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1
Injection-site pain
|
10.31 Percentage of Participants
Interval 9.3 to 11.38
|
SECONDARY outcome
Timeframe: Up to Day 28 (28 days after ProQuad® Dose 1)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3376 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1
|
7.43 Percentage of Participants
Interval 6.57 to 8.37
|
SECONDARY outcome
Timeframe: Up to Day 28 (28 days after ProQuad® Dose 1)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.
Outcome measures
| Measure |
ProQuad®
n=3376 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1
|
56.10 Percentage of Participants
Interval 0.85 to 1.61
|
SECONDARY outcome
Timeframe: Up to Day 28 (28 days after ProQuad® Dose 1)Population: All participants who received the first ProQuad® dose and had safety follow-up data available are included.
Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.
Outcome measures
| Measure |
ProQuad®
n=3376 Participants
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
|
|---|---|
|
Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1
|
64.10 Percentage of Participants
Interval 62.45 to 65.72
|
Adverse Events
ProQuad® Arm: Dose 2
Serious events: 22 serious events
Other events: 1507 other events
Deaths: 0 deaths
ProQuad® Arm: Dose 1
Serious events: 40 serious events
Other events: 2057 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ProQuad® Arm: Dose 2
n=3342 participants at risk
Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42.
|
ProQuad® Arm: Dose 1
n=3376 participants at risk
Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1.
|
|---|---|---|
|
Cardiac disorders
Cyanosis
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
General disorders
Pyrexia
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Bronchitis
|
0.06%
2/3342 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Gastroenteritis
|
0.06%
2/3342 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.18%
6/3376 • Number of events 6 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.06%
2/3342 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
2/3342 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Nervous system disorders
Facial paresis
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Nervous system disorders
Febrile convulsion
|
0.18%
6/3342 • Number of events 6 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.30%
10/3376 • Number of events 10 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Psychiatric disorders
Sleep terror
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.00%
0/3376 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3342 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Acute tonsilitis
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Gastroenteritis Norwalk virus
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.06%
2/3376 • Number of events 2 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3342 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
0.03%
1/3376 • Number of events 1 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
Other adverse events
| Measure |
ProQuad® Arm: Dose 2
n=3342 participants at risk
Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42.
|
ProQuad® Arm: Dose 1
n=3376 participants at risk
Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1.
|
|---|---|---|
|
General disorders
Injection site erythema
|
30.6%
1024/3342 • Number of events 1032 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
18.6%
628/3376 • Number of events 664 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
General disorders
Injection site pain
|
11.5%
384/3342 • Number of events 385 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
10.4%
351/3376 • Number of events 352 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
General disorders
Injection site swelling
|
13.4%
447/3342 • Number of events 449 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
6.7%
225/3376 • Number of events 228 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
General disorders
Pyrexia
|
15.7%
526/3342 • Number of events 591 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
33.2%
1122/3376 • Number of events 1274 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
174/3342 • Number of events 184 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
5.5%
185/3376 • Number of events 198 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
111/3342 • Number of events 120 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
5.7%
191/3376 • Number of events 207 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Infections and infestations
Rhinits
|
4.2%
142/3342 • Number of events 148 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
5.4%
181/3376 • Number of events 198 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
166/3342 • Number of events 178 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
5.9%
199/3376 • Number of events 211 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
101/3342 • Number of events 103 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
6.7%
226/3376 • Number of events 235 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
|
Skin and subcutaneous tissue disorders
Rash mobilliform
|
1.6%
54/3342 • Number of events 55 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
6.9%
232/3376 • Number of events 236 • ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
|
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