Trial Outcomes & Findings for Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines (NCT NCT03530124)
NCT ID: NCT03530124
Last Updated: 2024-02-14
Results Overview
Number of infants with ≥ 1 apneic event in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group, mITT Population Apnea was defined as a pause in respirations of \>20 seconds, or a pause in respirations of \>15 seconds with associated bradycardia (heart rate \<80 beats per minute for any duration occurring within 1 minute of the apnea event). Potential apnea events triggered by the cardiorespiratory monitors were manually reviewed by 2 neonatologists to verify the event. In uncommon situations in which manual review of a triggered event was not possible due to missing data, the triggered event was considered to be apnea.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
223 participants
Primary outcome timeframe
48 hours
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
Vaccinated
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
116
|
|
Overall Study
COMPLETED
|
105
|
115
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Vaccinated
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Discharged prior to study completion
|
1
|
0
|
Baseline Characteristics
Data not collected on 6 participants.
Baseline characteristics by cohort
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Gestational Age at Birth
|
27.3 Gestational Age in Weeks
n=107 Participants
|
27.7 Gestational Age in Weeks
n=116 Participants
|
27.6 Gestational Age in Weeks
n=223 Participants
|
|
Age, Customized
Age: <28 wks
|
60 Participants
n=107 Participants
|
61 Participants
n=116 Participants
|
121 Participants
n=223 Participants
|
|
Age, Customized
Age: >=28 wks
|
47 Participants
n=107 Participants
|
55 Participants
n=116 Participants
|
102 Participants
n=223 Participants
|
|
Age, Customized
Postmenstrual Age
|
36.6 Postmenstrual Age in Weeks
n=107 Participants
|
36.6 Postmenstrual Age in Weeks
n=116 Participants
|
36.6 Postmenstrual Age in Weeks
n=223 Participants
|
|
Age, Customized
Postnatal Age
|
8.7 Postnatal Age in Weeks
n=107 Participants
|
8.7 Postnatal Age in Weeks
n=116 Participants
|
8.7 Postnatal Age in Weeks
n=223 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=107 Participants
|
60 Participants
n=116 Participants
|
117 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=107 Participants
|
56 Participants
n=116 Participants
|
106 Participants
n=223 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=107 Participants
|
10 Participants
n=116 Participants
|
26 Participants
n=223 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=107 Participants
|
103 Participants
n=116 Participants
|
192 Participants
n=223 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=107 Participants
|
3 Participants
n=116 Participants
|
5 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
White Only
|
55 Participants
n=107 Participants
|
66 Participants
n=116 Participants
|
121 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
Black Only
|
33 Participants
n=107 Participants
|
42 Participants
n=116 Participants
|
75 Participants
n=223 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=107 Participants
|
8 Participants
n=116 Participants
|
27 Participants
n=223 Participants
|
|
Multiple Gestation
Single
|
73 Participants
n=107 Participants
|
84 Participants
n=116 Participants
|
157 Participants
n=223 Participants
|
|
Multiple Gestation
Twins
|
34 Participants
n=107 Participants
|
30 Participants
n=116 Participants
|
64 Participants
n=223 Participants
|
|
Multiple Gestation
Triplets
|
0 Participants
n=107 Participants
|
2 Participants
n=116 Participants
|
2 Participants
n=223 Participants
|
|
Birth Weight
|
940 Grams
n=107 Participants
|
1000 Grams
n=116 Participants
|
970 Grams
n=223 Participants
|
|
Insurance
Any Private
|
50 Participants
n=107 Participants
|
49 Participants
n=116 Participants
|
99 Participants
n=223 Participants
|
|
Insurance
Public
|
55 Participants
n=107 Participants
|
66 Participants
n=116 Participants
|
121 Participants
n=223 Participants
|
|
Insurance
None
|
2 Participants
n=107 Participants
|
1 Participants
n=116 Participants
|
3 Participants
n=223 Participants
|
|
Reason for Preterm Delivery
Hypertension/Preeclampsia/Hemolysis, Elevated Liver Enzymes, Low Platelet Count (HELLP)
|
30 Participants
n=107 Participants
|
25 Participants
n=116 Participants
|
55 Participants
n=223 Participants
|
|
Reason for Preterm Delivery
Preterm Labor/Premature Rupture
|
55 Participants
n=107 Participants
|
69 Participants
n=116 Participants
|
124 Participants
n=223 Participants
|
|
Reason for Preterm Delivery
Placental Abruption
|
12 Participants
n=107 Participants
|
12 Participants
n=116 Participants
|
24 Participants
n=223 Participants
|
|
Reason for Preterm Delivery
Fetal distress
|
18 Participants
n=107 Participants
|
22 Participants
n=116 Participants
|
40 Participants
n=223 Participants
|
|
Reason for Preterm Delivery
Other
|
25 Participants
n=107 Participants
|
29 Participants
n=116 Participants
|
54 Participants
n=223 Participants
|
|
Received Synagis During Study Period
Yes
|
0 Participants
n=107 Participants
|
1 Participants
n=116 Participants
|
1 Participants
n=223 Participants
|
|
Received Synagis During Study Period
No
|
107 Participants
n=107 Participants
|
115 Participants
n=116 Participants
|
222 Participants
n=223 Participants
|
|
Received Caffeine
Yes
|
98 Participants
n=102 Participants • Data not collected on 6 participants.
|
107 Participants
n=115 Participants • Data not collected on 6 participants.
|
205 Participants
n=217 Participants • Data not collected on 6 participants.
|
|
Received Caffeine
No
|
4 Participants
n=102 Participants • Data not collected on 6 participants.
|
8 Participants
n=115 Participants • Data not collected on 6 participants.
|
12 Participants
n=217 Participants • Data not collected on 6 participants.
|
|
Sibling Enrolled in Study
Yes
|
28 Participants
n=107 Participants
|
24 Participants
n=116 Participants
|
52 Participants
n=223 Participants
|
|
Sibling Enrolled in Study
No
|
79 Participants
n=107 Participants
|
92 Participants
n=116 Participants
|
171 Participants
n=223 Participants
|
|
Respiratory Support at Randomization
Continuous Positive Airway Pressure (CPAP)
|
17 Participants
n=106 Participants • Data not collected on 1 participant.
|
16 Participants
n=116 Participants • Data not collected on 1 participant.
|
33 Participants
n=222 Participants • Data not collected on 1 participant.
|
|
Respiratory Support at Randomization
Nasal Cannula
|
34 Participants
n=106 Participants • Data not collected on 1 participant.
|
46 Participants
n=116 Participants • Data not collected on 1 participant.
|
80 Participants
n=222 Participants • Data not collected on 1 participant.
|
|
Respiratory Support at Randomization
None
|
55 Participants
n=106 Participants • Data not collected on 1 participant.
|
54 Participants
n=116 Participants • Data not collected on 1 participant.
|
109 Participants
n=222 Participants • Data not collected on 1 participant.
|
|
Combination Vaccine Brand Administered
Pediarix
|
100 Participants
n=102 Participants • Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
0 Participants
Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
100 Participants
n=102 Participants • Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
|
Combination Vaccine Brand Administered
Pentacel
|
2 Participants
n=102 Participants • Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
0 Participants
Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
2 Participants
n=102 Participants • Collection of combination vaccine data were collected for the vaccinated arm only. Data not collected on 5 participants.
|
|
Haemophilus influenzae type b Vaccine Brand Administered
ActHIB
|
98 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
0 Participants
Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
98 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
|
Haemophilus influenzae type b Vaccine Brand Administered
PedvaxHIB
|
1 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
0 Participants
Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
1 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
|
Haemophilus influenzae type b Vaccine Brand Administered
Hiberix
|
1 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
0 Participants
Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
1 Participants
n=100 Participants • Collection of Haemophilus influenzae type b vaccine data were collected for the vaccinated arm only. Data not collected on 7 participants.
|
|
Hepatitis B Vaccine Brand Administered - Engerix-B
|
1 Participants
n=107 Participants • Collection of Hepatitis B vaccine data were collected for the vaccinated arm only.
|
0 Participants
Collection of Hepatitis B vaccine data were collected for the vaccinated arm only.
|
1 Participants
n=107 Participants • Collection of Hepatitis B vaccine data were collected for the vaccinated arm only.
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The mITT population includes any infant that was enrolled and randomized in the study.
Number of infants with ≥ 1 apneic event in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group, mITT Population Apnea was defined as a pause in respirations of \>20 seconds, or a pause in respirations of \>15 seconds with associated bradycardia (heart rate \<80 beats per minute for any duration occurring within 1 minute of the apnea event). Potential apnea events triggered by the cardiorespiratory monitors were manually reviewed by 2 neonatologists to verify the event. In uncommon situations in which manual review of a triggered event was not possible due to missing data, the triggered event was considered to be apnea.
Outcome measures
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Occurrence of Apnea
Yes
|
25 Participants
|
12 Participants
|
|
Occurrence of Apnea
No
|
80 Participants
|
104 Participants
|
|
Occurrence of Apnea
Missing
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The mITT population includes any infant that was enrolled and randomized in the study.
Average number of apneic episodes in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.
Outcome measures
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Number of Apneic Episodes
|
2.72 Apneic Episodes
Standard Deviation 2.76
|
2.00 Apneic Episodes
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The mITT population includes any infant that was enrolled and randomized in the study.
Average duration of apneic episodes in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.
Outcome measures
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Duration of Apneic Episodes
|
27.7 seconds
Standard Deviation 2.6
|
32.3 seconds
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The mITT population includes any infant that was enrolled and randomized in the study.
Proportion of infants requiring any increase in respiratory support in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.
Outcome measures
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Increase in Respiratory Support
Yes
|
8 Participants
|
4 Participants
|
|
Increase in Respiratory Support
No
|
92 Participants
|
112 Participants
|
|
Increase in Respiratory Support
Missing
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: mITT Analysis Population: Duke Site Only
Proportion of infants with severe ≥1 severe cardiorespiratory event in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group. Only severe apnea events in the mITT analysis window and only the severe bradycardia events in the mITT analysis window from Duke University. The monitor data were not viable at UNC and Cincinnati Children's Hospital. Duke data were adjudicated by neonatologists.
Outcome measures
| Measure |
Vaccinated
n=39 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=42 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Severe Cardiorespiratory Events
Yes
|
7 Participants
|
8 Participants
|
|
Severe Cardiorespiratory Events
No
|
31 Participants
|
34 Participants
|
|
Severe Cardiorespiratory Events
Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The mITT population includes any infant that was enrolled and randomized in the study.
Proportion of Infants Requiring Positive Pressure Ventilation in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.
Outcome measures
| Measure |
Vaccinated
n=107 Participants
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 Participants
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Positive Pressure Ventilation
Yes
|
2 Participants
|
1 Participants
|
|
Positive Pressure Ventilation
No
|
104 Participants
|
115 Participants
|
|
Positive Pressure Ventilation
Missing
|
1 Participants
|
0 Participants
|
Adverse Events
Vaccinated
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Unvaccinated
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccinated
n=107 participants at risk
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 participants at risk
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospital readmission for tachypnea
|
0.93%
1/107 • Number of events 1 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
0.00%
0/116 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
|
Eye disorders
Hospital readmission for retinopathy of prematurity
|
0.93%
1/107 • Number of events 1 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
0.00%
0/116 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
|
Surgical and medical procedures
Respiratory decompensation and hypotension following elective surgery
|
0.93%
1/107 • Number of events 1 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
0.00%
0/116 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
Other adverse events
| Measure |
Vaccinated
n=107 participants at risk
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
HBV: ACIP Recommended vaccine
IPV: ACIP Recommended vaccine
Hib: ACIP Recommended vaccine
|
Unvaccinated
n=116 participants at risk
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
|
|---|---|---|
|
Cardiac disorders
Severe Cardiorespiratory Event
|
17.9%
7/39 • Number of events 39 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
19.0%
8/42 • Number of events 8 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
≥ 1 Apneic Event
|
23.4%
25/107 • Number of events 25 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
10.3%
12/116 • Number of events 12 • Unvaccinated infants and vaccinated infants were followed for 48 hours for clinically important adverse events and serious adverse events. In addition, vaccinated infants were followed for 14 days after vaccination for clinically important adverse events and serious adverse events.
All clinically important adverse events (not including serious adverse event) outcome data were reported out within the study outcome measures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place